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The purpose of this project is to examine and compare the immediate and long-term effects of combined Botulinum toxin type A(BoNT-A) injection with exoskeleton Robotic assisted gait training (RABT) in patients with post-stroke stiff-knee gait.
The aim of the study is to evaluate the effects of BoNT-A combining with overground exoskeleton robot for patients with post-stroke stiff-knee gait.
Stiff-knee gait (SKG) is a common gait pattern in patients after stroke, characterized by limited knee flexion (KF) during the swing phase of walking. Botulinum toxin A (BoNT-A) injection in rectus femoris muscle is considered the gold standard procedure to treat SKG.
Patients with this gait pattern would reduce walking speed, cause toe dragging, compromise the stability of walking, increase risk of falling, and interfere with daily activities. This randomized controlled trial will contribute to the accelerated refinement and development of efficient and effective treatment programs for patients with post-stroke spastic stiff knee gait. The Robot-assisted gait training (RAGT) has the potential to be an optimal adjunctive therapy following BoNT-A treatment. Combinations of BoNT-A and rehabilitation training are suggested to optimize the treatment effect for spasticity related disabilities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RF BoNT-A injection in first period and robot therapy | Experimental | Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks. |
|
| RF BoNT-A injection in second period and robot therapy | Experimental | Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BoNT-A injections | Procedure | Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris. |
| Measure | Description | Time Frame |
|---|---|---|
| Kinematic Analysis (Including ROM of Each L/E Joints、Change in Gait Speed in Gait Cycle、Change in Center of Mass、Stride Length) | Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage. We calculate the relative change by subtracting the initial value from the final value and then dividing the answer by the absolute value of the initial number. (relative change = (post - baseline)/ baseline ×100%) Investigators will use a marker less motion capture system for kinematic analysis, use four high-definition cameras to record 30 fps at a resolution of 4 megapixels. The camera was placed uniformly 5 meters away from the center of the subject at the height of 1 meter, allowing for a maximum number of detections of the entire body. To analyze the kinematics of lower extremity, investigators use Open Pose, a real-time multi-person system, to detect human pose in 2D images Fromm the four high-definition cameras. Investigators will use this test to measure the angle of knee flexion and the step length (cm) of participants. | Relative change from baseline at 5 months |
| Data Analysis From the built-in Speed and Angle Sensors of the Exoskeleton Robot (Including ROM of the Joints, the Cyclogram Perimeter, the Cyclogram Area, Cyclogram Orientation, the Trend Symmetry, and the Square Root of the Sum of Squared Deviation | Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage. A cyclogram is used to represent the functional relationship between joints during a full gait cycle, and is constructed by plotting two angles on the X-Y plane (the alteration of the hip and knee joint). It has several types of clinically relevant parameters, such as ROM of the joints, the cyclogram perimeter, the cyclogram area. And we can also compare the different between affected and unaffected side by looking at the cyclogram orientation, the trend symmetry, and the square root of the sum of squared deviation (A value of 0 indicates greater symmetry and coordination) | Relative change from baseline at 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Emory Functional Ambulation Profile(mEFAP) | Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage. The mEFAP is a clinical test that measures the time to ambulate through five common environmental terrains with or without an assistive device .It has been demonstrated to have a high inter-rater and test-retest reliability as a measure of gait capacity and functional ambulation in the post stroke patient population. The mEFAP comprises five timed tasks: (1) a 5-m walk on a hard floor; (2) a 5-m walk on a carpeted surface; (3) to rise from a chair, a 3-m walk, and return to a seated position (the timed "up-and-go" test); (4) a standardized obstacle course; and (5) to ascent and descent five stairs. The five timed sub scores will be adjusted by a multiplier for any necessary assistive device and then add together to derive a composite score. |
| Measure | Description | Time Frame |
|---|---|---|
| Nottingham Extended Activities of Daily Living Index | Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage. The Nottingham Extended Activities of Daily Living Index (Eadl) is made up of 22 items divided into 4 sections, each item is scored from 0 to 3 points. Investigators only use Eadl index mobility subdomain to assess the community participation level of participants, which includes 6 items and ranges from 0 to 12, with higher scores indicating better performance. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hung Jen-Wen | Chang Gung Memorial Hospital-Kaohsiung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan | Kaohsiung City | Kaohsiung | 833 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11283399 | Background | Baer HR, Wolf SL. Modified emory functional ambulation profile: an outcome measure for the rehabilitation of poststroke gait dysfunction. Stroke. 2001 Apr;32(4):973-9. doi: 10.1161/01.str.32.4.973. | |
| 8931526 | Background | Beckerman H, Becher J, Lankhorst GJ, Verbeek AL. Walking ability of stroke patients: efficacy of tibial nerve blocking and a polypropylene ankle-foot orthosis. Arch Phys Med Rehabil. 1996 Nov;77(11):1144-51. doi: 10.1016/s0003-9993(96)90138-0. |
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30 of 40 participants were randomized. Of those not randomized, 4 declined to participate ,6 did not meeting inclusion criteria.
40 patients were screened for eligibility between August 1, 2023 and July 31, 2025 at Kaohsiung Chang Gung Memorial Hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | RF BoNT-A Injection Plus Robot Therapy Then Robot Therapy Only | Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks. BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris. RF BoNT-A injection in first period and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected in the affected rectus femoris, then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs. After a 3-month washout period crossover to none RF BoNT-A injection, and received second round of robot therapy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| first treatment |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 31, 2025 |
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There will be a research code representing patients' identity, this code will not show patients' name, social security number, and home address. For the results of patients' visit and the diagnosis, the study moderator will maintain a confidential attitude and be careful to maintain patients' privacy.
|
| RF BoNT-A injection in first period and robot therapy | Other | Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected in the affected rectus femoris, then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs. After a 3-month washout period crossover to none RF BoNT-A injection, and received second round of robot therapy. |
|
| RF BoNT-A injection in second period and robot therapy | Other | Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected (do not inject BoNT-A in the affected rectus femoris), then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs. After a 3-month washout period crossover to RF BoNT-A injection, and received second round of robot therapy. |
|
| Relative change from baseline at 5 months |
| Modified Ashworth Scale | Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage. Spasticity of skeletal muscle in lower extremity was evaluated by using the MAS scale. It uses a 8-point scale (0, 1, 1+,2, 2+, 3, 3+, 4) to score the average resistance to passive movement for each join with higher score indicating higher spasticity. The MAS has shown good reliability and validity. Investigators assessed the MAS of knee flexor/ extensor, ankle dorsiflexor/planta flexor in sitting position. The maximum of MAS scale is 4, and the minimum is 0. The higher scores mean a worse outcome. | Relative change from baseline at 5 months |
| Medical Research Council Scale | Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage. The MRC scale is a reliable measurement which ranges from 0 (no contraction) to 5 (normal power). Total scale combines all range and computes average scores, the higher scores mean a better outcome. The MRC scale will be used to examine the muscle strength of the affected hip flexion, knee flexion, knee extension, and ankle dorsiflexion. Select an appropriate testing posture based on the client's abilities.(If the client cannot be assessed in a standing position, use a sitting position instead, but it would result in a lower score.) | Relative change from baseline at 5 months |
| Pendulum Test | Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage. The pendulum test was performed to assess spasticity of the knee extensors. During each trial, inertial measurement unit (IMU) data were recorded, including angular velocity from the gyroscope, linear acceleration from the accelerometer, and magnetic field from the magnetometer. Pendular parameters (first swing excursion and relaxation index) were derived from knee angle trajectories measured using an electrogoniometer. The proximal and distal sensor endblocks were secured 15 cm above and 15 cm below the lateral femoral epicondyle, respectively. The two sensor were used to obtain one integrated knee-joint angle signal based on the relative motion between segments, rather than two separate outputs. Previous study showed the pendular parameters can provide additional ambulatory information, as complementary to the MAS . | Relative change from baseline at 5 months |
| Berg Balance Scale | Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage. The BBS is a 14-item scale, which is widely used to assess balance disorders in people with stroke, each item is scored from 0 to 4 points. The reliability and validity of the BBS are well established. Investigators used BBS for balance function assessment. The higher scores mean a better outcome. | Relative change from baseline at 5 months |
| Six-Minute Walking Test | Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage. The 6MWT is commonly used to assess patients' cardiovascular or respiratory problems and is regarded as a submaximal test of aerobic capacity. Investigators will use 6MWT to assess walking endurance. It is now commonly used in stroke patients and is highly reliable in this group. The maximum distance covered on a 20-m walkway in 6 mins is recorded. | Relative change from baseline at 5 months |
| Isometric Strength | Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage. Isometric strength was measured using the Biodex System 3a. Investigators use to test consisting of three knee flexion/extension isometric contractions at 30°, 45°, 90° knee flexion, and record data of isometric peak torque (Nm/kg).Five-second maximal voluntary isometric contraction (MVIC) trials were performed ten times. A rest of 15s was given between contractions for each trial, and the interval between two angles was approximately 2 min. Isometric peak torque (Nm/kg) was calculated as the highest value from the filtered torque data during each MVIC, which was normalized by the body mass. The isometric peak torque (Nm) was obtained from the Biodex System 3 software for both flexion and extension. | Relative change from baseline at 5 months |
| Relative change from baseline at 5 months |
| Activities-specific Balance Confidence | Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage. The Activities-specific Balance confidence (ABS) scale is a questionnaire developed to assess older individual's balance confidence in performing daily activities. ABC scale consists of a wide continuum of less and more challenging daily activities. The ABS scale has 16 items, representing daily activities. Participants are asked to answer, with a score from 0% (not confident at all) to 100% (completely confident) in increments of 10%, how confident they are in performing each activity. The average score obtained is an indication on balance confidence. | Relative change from baseline at 5 months |
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| 18322637 | Background | Rosales RL, Chua-Yap AS. Evidence-based systematic review on the efficacy and safety of botulinum toxin-A therapy in post-stroke spasticity. J Neural Transm (Vienna). 2008;115(4):617-23. doi: 10.1007/s00702-007-0869-3. Epub 2008 Mar 6. |
| 3809245 | Background | Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206. |
| 25263601 | Background | Santamato A, Micello MF, Panza F, Fortunato F, Baricich A, Cisari C, Pilotto A, Logroscino G, Fiore P, Ranieri M. Can botulinum toxin type A injection technique influence the clinical outcome of patients with post-stroke upper limb spasticity? A randomized controlled trial comparing manual needle placement and ultrasound-guided injection techniques. J Neurol Sci. 2014 Dec 15;347(1-2):39-43. doi: 10.1016/j.jns.2014.09.016. Epub 2014 Sep 19. |
| 27291256 | Background | Santamato A, Ranieri M, Solfrizzi V, Lozupone M, Vecchio M, Daniele A, Greco A, Seripa D, Logroscino G, Panza F. High doses of incobotulinumtoxinA for the treatment of post-stroke spasticity: are they safe and effective? Expert Opin Drug Metab Toxicol. 2016 Aug;12(8):843-6. doi: 10.1080/17425255.2016.1198318. Epub 2016 Jun 17. No abstract available. |
| 30048444 | Background | Seth A, Hicks JL, Uchida TK, Habib A, Dembia CL, Dunne JJ, Ong CF, DeMers MS, Rajagopal A, Millard M, Hamner SR, Arnold EM, Yong JR, Lakshmikanth SK, Sherman MA, Ku JP, Delp SL. OpenSim: Simulating musculoskeletal dynamics and neuromuscular control to study human and animal movement. PLoS Comput Biol. 2018 Jul 26;14(7):e1006223. doi: 10.1371/journal.pcbi.1006223. eCollection 2018 Jul. |
| 18164331 | Background | Stoquart GG, Detrembleur C, Palumbo S, Deltombe T, Lejeune TM. Effect of botulinum toxin injection in the rectus femoris on stiff-knee gait in people with stroke: a prospective observational study. Arch Phys Med Rehabil. 2008 Jan;89(1):56-61. doi: 10.1016/j.apmr.2007.08.131. |
| 24309072 | Background | Tenniglo MJ, Nederhand MJ, Prinsen EC, Nene AV, Rietman JS, Buurke JH. Effect of chemodenervation of the rectus femoris muscle in adults with a stiff knee gait due to spastic paresis: a systematic review with a meta-analysis in patients with stroke. Arch Phys Med Rehabil. 2014 Mar;95(3):576-87. doi: 10.1016/j.apmr.2013.11.008. Epub 2013 Dec 3. |
| 22311056 | Background | Tok F, Balaban B, Yasar E, Alaca R, Tan AK. The effects of onabotulinum toxin A injection into rectus femoris muscle in hemiplegic stroke patients with stiff-knee gait: a placebo-controlled, nonrandomized trial. Am J Phys Med Rehabil. 2012 Apr;91(4):321-6. doi: 10.1097/PHM.0b013e3182465feb. |
| 23570893 | Background | Trompetto C, Marinelli L, Mori L, Cossu E, Zilioli R, Simonini M, Abbruzzese G, Baratto L. Postactivation depression changes after robotic-assisted gait training in hemiplegic stroke patients. Gait Posture. 2013 Sep;38(4):729-33. doi: 10.1016/j.gaitpost.2013.03.011. Epub 2013 Apr 6. |
| 17451615 | Background | Tsai RC, Lin KN, Wang HJ, Liu HC. Evaluating the uses of the total score and the domain scores in the Cognitive Abilities Screening Instrument, Chinese version (CASI C-2.0): results of confirmatory factor analysis. Int Psychogeriatr. 2007 Dec;19(6):1051-63. doi: 10.1017/S1041610207005327. Epub 2007 Apr 23. |
| 479242 | Background | Waters RL, Garland DE, Perry J, Habig T, Slabaugh P. Stiff-legged gait in hemiplegia: surgical correction. J Bone Joint Surg Am. 1979 Sep;61(6A):927-33. |
| 16446538 | Background | Welmer AK, von Arbin M, Widen Holmqvist L, Sommerfeld DK. Spasticity and its association with functioning and health-related quality of life 18 months after stroke. Cerebrovasc Dis. 2006;21(4):247-53. doi: 10.1159/000091222. Epub 2006 Jan 27. |
| 23319481 | Background | Wissel J, Manack A, Brainin M. Toward an epidemiology of poststroke spasticity. Neurology. 2013 Jan 15;80(3 Suppl 2):S13-9. doi: 10.1212/WNL.0b013e3182762448. |
| 25171879 | Background | Wissel J, Verrier M, Simpson DM, Charles D, Guinto P, Papapetropoulos S, Sunnerhagen KS. Post-stroke spasticity: predictors of early development and considerations for therapeutic intervention. PM R. 2015 Jan;7(1):60-7. doi: 10.1016/j.pmrj.2014.08.946. Epub 2014 Aug 27. |
| 10066855 | Background | Yelnik A, Albert T, Bonan I, Laffont I. A clinical guide to assess the role of lower limb extensor overactivity in hemiplegic gait disorders. Stroke. 1999 Mar;30(3):580-5. doi: 10.1161/01.str.30.3.580. |
| FG001 | Robot Therapy Only Then RF BoNT-A Injection Plus Robot Therapy | Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks. BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris. RF BoNT-A injection in second period and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected (do not inject BoNT-A in the affected rectus femoris), then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs. After a 3-month washout period crossover to RF BoNT-A injection, and received second round of robot therapy. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| wash out |
|
|
| second treatment |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | RF BoNT-A Injection in First Period and Robot Therapy | Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks. BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris. RF BoNT-A injection and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected in the affected rectus femoris, then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs. After a 3-month washout period crossover to none RF BoNT-A injection, and received second round of robot therapy. |
| BG001 | RF BoNT-A Injection in Second Period and Robot Therapy | Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks. BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris. RF BoNT-A injection and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected (do not inject BoNT-A in the affected rectus femoris), then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs. After a 3-month washout period crossover to RF BoNT-A injection, and received second round of robot therapy. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| stroke survival period | Mean | Standard Deviation | months |
| |||||||||||||||
| Affected Side | Count of Participants | Participants |
| ||||||||||||||||
| Botulinum toxin A dosage | We placed the botulinum toxin A dosage under the baseline characteristics because this study primarily examines whether robot therapy combined with a botulinum toxin injection into the rectus femoris yields better outcomes than robot therapy without a rectus femoris injection. Therefore, both groups will receive botulinum toxin; we only need to verify whether the injection doses differ between groups. | Mean | Standard Deviation | units |
| ||||||||||||||
| Functional Ambulation Category | The Functional Ambulation Categories is a 6-point functional walking test that evaluates ambulation ability, determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device. 0 means nonfunctional ambulator, while 5 means independent. | Mean | Standard Deviation | scores on a scale |
| ||||||||||||||
| Use of Ankle-Foot Orthosis | Count of Participants | Participants |
| ||||||||||||||||
| Use of Assisted devices | Count of Participants | Participants |
| ||||||||||||||||
| Mini-Mental State Examination | Mini-Mental State Examination is a 11-question test that screens for cognitive impairment by assessing orientation, attention, memory, language, and visuospatial skills. It is a 30-point questionnaire, and has a minimum score of 0 and a maximum score of 30. 24-30: typically no or minimal cognitive impairment 18-23: mild to moderate cognitive impairment 0-17: moderate to severe cognitive impairment | Mean | Standard Deviation | scores on a scale |
| ||||||||||||||
| Education | Mean | Standard Deviation | years |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Kinematic Analysis (Including ROM of Each L/E Joints、Change in Gait Speed in Gait Cycle、Change in Center of Mass、Stride Length) | Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage. We calculate the relative change by subtracting the initial value from the final value and then dividing the answer by the absolute value of the initial number. (relative change = (post - baseline)/ baseline ×100%) Investigators will use a marker less motion capture system for kinematic analysis, use four high-definition cameras to record 30 fps at a resolution of 4 megapixels. The camera was placed uniformly 5 meters away from the center of the subject at the height of 1 meter, allowing for a maximum number of detections of the entire body. To analyze the kinematics of lower extremity, investigators use Open Pose, a real-time multi-person system, to detect human pose in 2D images Fromm the four high-definition cameras. Investigators will use this test to measure the angle of knee flexion and the step length (cm) of participants. | We included the data of participants who received a botulinum toxin injection to rectus femoris into one group for analysis, and those who did not into the other; both groups underwent robot therapy. As the group titles indicates. | Posted | Mean | Standard Deviation | percentage (relative change) | Relative change from baseline at 5 months |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Data Analysis From the built-in Speed and Angle Sensors of the Exoskeleton Robot (Including ROM of the Joints, the Cyclogram Perimeter, the Cyclogram Area, Cyclogram Orientation, the Trend Symmetry, and the Square Root of the Sum of Squared Deviation | Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage. A cyclogram is used to represent the functional relationship between joints during a full gait cycle, and is constructed by plotting two angles on the X-Y plane (the alteration of the hip and knee joint). It has several types of clinically relevant parameters, such as ROM of the joints, the cyclogram perimeter, the cyclogram area. And we can also compare the different between affected and unaffected side by looking at the cyclogram orientation, the trend symmetry, and the square root of the sum of squared deviation (A value of 0 indicates greater symmetry and coordination) | We included the data of participants who received a botulinum toxin injection to rectus femoris into one group for analysis, and those who did not into the other; both groups underwent robot therapy. As the group titles indicates. | Posted | Mean | Standard Deviation | percentage (relative change) | Relative change from baseline at 5 months |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Modified Emory Functional Ambulation Profile(mEFAP) | Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage. The mEFAP is a clinical test that measures the time to ambulate through five common environmental terrains with or without an assistive device .It has been demonstrated to have a high inter-rater and test-retest reliability as a measure of gait capacity and functional ambulation in the post stroke patient population. The mEFAP comprises five timed tasks: (1) a 5-m walk on a hard floor; (2) a 5-m walk on a carpeted surface; (3) to rise from a chair, a 3-m walk, and return to a seated position (the timed "up-and-go" test); (4) a standardized obstacle course; and (5) to ascent and descent five stairs. The five timed sub scores will be adjusted by a multiplier for any necessary assistive device and then add together to derive a composite score. | We included the data of participants who received a botulinum toxin injection to rectus femoris into one group for analysis, and those who did not into the other; both groups underwent robot therapy. As the group titles indicates. | Posted | Mean | Standard Deviation | percentage (relative change) | Relative change from baseline at 5 months |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Modified Ashworth Scale | Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage. Spasticity of skeletal muscle in lower extremity was evaluated by using the MAS scale. It uses a 8-point scale (0, 1, 1+,2, 2+, 3, 3+, 4) to score the average resistance to passive movement for each join with higher score indicating higher spasticity. The MAS has shown good reliability and validity. Investigators assessed the MAS of knee flexor/ extensor, ankle dorsiflexor/planta flexor in sitting position. The maximum of MAS scale is 4, and the minimum is 0. The higher scores mean a worse outcome. | We included the data of participants who received a botulinum toxin injection to rectus femoris into one group for analysis, and those who did not into the other; both groups underwent robot therapy. As the group titles indicates. | Posted | Mean | Standard Deviation | percentage (relative change) | Relative change from baseline at 5 months |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Medical Research Council Scale | Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage. The MRC scale is a reliable measurement which ranges from 0 (no contraction) to 5 (normal power). Total scale combines all range and computes average scores, the higher scores mean a better outcome. The MRC scale will be used to examine the muscle strength of the affected hip flexion, knee flexion, knee extension, and ankle dorsiflexion. Select an appropriate testing posture based on the client's abilities.(If the client cannot be assessed in a standing position, use a sitting position instead, but it would result in a lower score.) | We included the data of participants who received a botulinum toxin injection to rectus femoris into one group for analysis, and those who did not into the other; both groups underwent robot therapy. As the group titles indicates. | Posted | Mean | Standard Deviation | percentage (relative change) | Relative change from baseline at 5 months |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Pendulum Test | Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage. The pendulum test was performed to assess spasticity of the knee extensors. During each trial, inertial measurement unit (IMU) data were recorded, including angular velocity from the gyroscope, linear acceleration from the accelerometer, and magnetic field from the magnetometer. Pendular parameters (first swing excursion and relaxation index) were derived from knee angle trajectories measured using an electrogoniometer. The proximal and distal sensor endblocks were secured 15 cm above and 15 cm below the lateral femoral epicondyle, respectively. The two sensor were used to obtain one integrated knee-joint angle signal based on the relative motion between segments, rather than two separate outputs. Previous study showed the pendular parameters can provide additional ambulatory information, as complementary to the MAS . | We included the data of participants who received a botulinum toxin injection to rectus femoris into one group for analysis, and those who did not into the other; both groups underwent robot therapy. As the group titles indicates. | Posted | Mean | Standard Deviation | percentage (relative change) | Relative change from baseline at 5 months |
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| Secondary | Berg Balance Scale | Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage. The BBS is a 14-item scale, which is widely used to assess balance disorders in people with stroke, each item is scored from 0 to 4 points. The reliability and validity of the BBS are well established. Investigators used BBS for balance function assessment. The higher scores mean a better outcome. | We included the data of participants who received a botulinum toxin injection to rectus femoris into one group for analysis, and those who did not into the other; both groups underwent robot therapy. As the group titles indicates. | Posted | Mean | Standard Deviation | percentage (relative change) | Relative change from baseline at 5 months |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Six-Minute Walking Test | Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage. The 6MWT is commonly used to assess patients' cardiovascular or respiratory problems and is regarded as a submaximal test of aerobic capacity. Investigators will use 6MWT to assess walking endurance. It is now commonly used in stroke patients and is highly reliable in this group. The maximum distance covered on a 20-m walkway in 6 mins is recorded. | We included the data of participants who received a botulinum toxin injection to rectus femoris into one group for analysis, and those who did not into the other; both groups underwent robot therapy. As the group titles indicates. | Posted | Mean | Standard Deviation | percentage (relative change) | Relative change from baseline at 5 months |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Isometric Strength | Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage. Isometric strength was measured using the Biodex System 3a. Investigators use to test consisting of three knee flexion/extension isometric contractions at 30°, 45°, 90° knee flexion, and record data of isometric peak torque (Nm/kg).Five-second maximal voluntary isometric contraction (MVIC) trials were performed ten times. A rest of 15s was given between contractions for each trial, and the interval between two angles was approximately 2 min. Isometric peak torque (Nm/kg) was calculated as the highest value from the filtered torque data during each MVIC, which was normalized by the body mass. The isometric peak torque (Nm) was obtained from the Biodex System 3 software for both flexion and extension. | We included the data of participants who received a botulinum toxin injection to rectus femoris into one group for analysis, and those who did not into the other; both groups underwent robot therapy. As the group titles indicates. | Posted | Mean | Standard Deviation | percentage (relative change) | Relative change from baseline at 5 months |
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Nottingham Extended Activities of Daily Living Index | Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage. The Nottingham Extended Activities of Daily Living Index (Eadl) is made up of 22 items divided into 4 sections, each item is scored from 0 to 3 points. Investigators only use Eadl index mobility subdomain to assess the community participation level of participants, which includes 6 items and ranges from 0 to 12, with higher scores indicating better performance. | We included the data of participants who received a botulinum toxin injection to rectus femoris into one group for analysis, and those who did not into the other; both groups underwent robot therapy. As the group titles indicates. | Posted | Mean | Standard Deviation | percentage (relative change) | Relative change from baseline at 5 months |
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Activities-specific Balance Confidence | Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage. The Activities-specific Balance confidence (ABS) scale is a questionnaire developed to assess older individual's balance confidence in performing daily activities. ABC scale consists of a wide continuum of less and more challenging daily activities. The ABS scale has 16 items, representing daily activities. Participants are asked to answer, with a score from 0% (not confident at all) to 100% (completely confident) in increments of 10%, how confident they are in performing each activity. The average score obtained is an indication on balance confidence. | We included the data of participants who received a botulinum toxin injection to rectus femoris into one group for analysis, and those who did not into the other; both groups underwent robot therapy. As the group titles indicates. | Posted | Mean | Standard Deviation | percentage (relative change) | Relative change from baseline at 5 months |
|
All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed
All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RF BoNT-A Injection and Robot Therapy | Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks. BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris. RF BoNT-A injection and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected in the affected rectus femoris, then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | None RF BoNT-A Injection and Robot Therapy | Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks. BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris. RF BoNT-A injection and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected (do not inject BoNT-A in the affected rectus femoris), then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs. | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jen-Wen Hung, MD | Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan | +886975056689 | hung0702@cgmh.org.tw |
| Aug 6, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D020233 | Gait Disorders, Neurologic |
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| right |
|
| Total |
|
| No |
|
| Quadricane |
|
| none |
|
| Knee flexion / extension angle (affected side) |
|
| Knee flexion / extension angle (unaffected side) |
|
| Ankle dorsiflexion / plantar flexion angle (affected side) |
|
| Ankle dorsiflexion / plantar flexion angle (unaffected side) |
|
| Maximum Mean Speed |
|
| Variability of speed on steady state (rms) |
|
| Variability of speed on Acceleration and Decceleration state (rms) |
|
| Variability of speed on All state (rms) |
|
| Center of Mass of Lateral direction for AUC |
|
| Center of Mass of vertical direction for distance swings |
|
| Stride length (affected side) |
|
| Stride length (unaffected side) |
|
| OG001 | None RF BoNT-A Injection and Robot Therapy | Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks. BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris. RF BoNT-A injection and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected (do not inject BoNT-A in the affected rectus femoris), then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs. |
|
|
| OG001 | None RF BoNT-A Injection and Robot Therapy | Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks. BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris. RF BoNT-A injection and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected (do not inject BoNT-A in the affected rectus femoris), then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs. |
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| OG001 | None RF BoNT-A Injection and Robot Therapy | Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks. BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris. RF BoNT-A injection and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected (do not inject BoNT-A in the affected rectus femoris), then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs. |
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| OG001 | None RF BoNT-A Injection and Robot Therapy | Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks. BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris. RF BoNT-A injection and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected (do not inject BoNT-A in the affected rectus femoris), then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs. |
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| OG001 | None RF BoNT-A Injection and Robot Therapy | Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks. BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris. RF BoNT-A injection and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected (do not inject BoNT-A in the affected rectus femoris), then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs. |
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| OG001 | None RF BoNT-A Injection and Robot Therapy | Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks. BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris. RF BoNT-A injection and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected (do not inject BoNT-A in the affected rectus femoris), then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs. |
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| OG001 | None RF BoNT-A Injection and Robot Therapy | Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks. BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris. RF BoNT-A injection and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected (do not inject BoNT-A in the affected rectus femoris), then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs. |
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| OG001 | None RF BoNT-A Injection and Robot Therapy | Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks. BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris. RF BoNT-A injection and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected (do not inject BoNT-A in the affected rectus femoris), then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs. |
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| OG001 | None RF BoNT-A Injection and Robot Therapy | Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks. BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris. RF BoNT-A injection and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected (do not inject BoNT-A in the affected rectus femoris), then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs. |
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| OG001 | None RF BoNT-A Injection and Robot Therapy | Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks. BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris. RF BoNT-A injection and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected (do not inject BoNT-A in the affected rectus femoris), then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs. |
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