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The purpose of this study is to investigate whether robotic exoskeleton training can improve walking performance after SCI as compared to conventional physical therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic exoskeleton training | Experimental | During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise. |
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| Conventional Physical Therapy | Active Comparator | During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic exoskeleton training | Device | During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Over Ground Gait Speed as Assessed by the 10 Meter Walk Test | The 10 Meter Walk Test assesses the time taken to walk 10 meters. | baseline, week 4 |
| Change in Walking Endurance as Assessed by the 6 Minute Walk Test | The 6 Minute Walk Test assesses the distance walked in 6 minutes. | baseline, week 4 |
| Change in Dynamic Mobility Assessment as Determined by the Timed Up and Go Test | The Timed Up and Go test assessed the time it takes to stand from a sitting position, complete a 3 meter walk, and then return to sitting. | baseline, week 4 |
| Change in Muscle Activity as Assessed by Surface Electromyography (EMG) | Surface EMG sensors will be placed on the skin of subjects' lower extremities and trunk to measure muscle activity. Only one participant data was analyzed. Emg was recorded from the soleus, gastrocnemius, tibialis anterior, rectus femoris, vastus medialis, bicep femoris and semitendinosus muscles. The outcome measure is the %age change between the baseline and 4 week assessments. Negative values denotes decrease in muscle activity at 4 week compared to baseline. | baseline, week 4 |
| Change in Energy Expenditure During Walking as Assessed by Oxygen Cost | Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight.20 Oxygen consumption will be calculated on a breath-by-breath basis measured by a portable metabolic system (Cosmed K4b2). | baseline, week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gait Characteristics as Assessed by the GAITRite Walkway (Cadence) | Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. Cadence is measured as steps/min. Change in cadence is reported as difference between baseline and post assessment. | baseline, week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Davis, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29556414 | Derived | Chang SH, Afzal T; TIRR SCI Clinical Exoskeleton Group; Berliner J, Francisco GE. Exoskeleton-assisted gait training to improve gait in individuals with spinal cord injury: a pilot randomized study. Pilot Feasibility Stud. 2018 Mar 5;4:62. doi: 10.1186/s40814-018-0247-y. eCollection 2018. |
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One participant dropped out of the study after signing the consent before randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | Robotic Exoskeleton Training | During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Conventional physical therapy | Other | During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period. |
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| Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Length) | Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. The change in step length between baseline and post assessment is reported. Negative value denotes decrease in step length. | baseline, week 4 |
| Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Time) | Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. The outcome measure is the difference in step time between pre and post assessment. Negative value denotes decrease in step time (implying faster step time at post). | baseline, week 4 |
| Change in Lower Extremity Strength as Assessed by American Spinal Injury Association (ASIA) Lower Extremity Motor Score (LEMS) | The ASIA (American Spinal Injury Association) assessment protocol consists of two sensory examinations, a motor examination and a classification framework (the impairment scale) to quantify the severity of the spinal cord injury. The scale informs about the functionality of the patient. The range of scores is 0 to 5, and high values represent better outcome. Following is the description of the range: 0 = total paralysis
We report the difference between baseline and 4week assessments. Negative value denotes decrease at post assessment. | baseline, week 4 |
| Exoskeleton User Feedback as Assessed by a Questionnaire | A questionnaire will be administered to allow participants to provide feedback regarding their experiences during training sessions with the exoskeleton. The units on a scale was used to measure the feedback. The range of the scale was 1-5. '1' refers to very satisfied and '5' refers to very dissatisfied. '1' refers to a better outcome. | week 4 |
| FG001 | Conventional Physical Therapy | During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Robotic Exoskeleton Training | During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise. |
| BG001 | Conventional Physical Therapy | During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Change in Over Ground Gait Speed as Assessed by the 10 Meter Walk Test | The 10 Meter Walk Test assesses the time taken to walk 10 meters. | Posted | Mean | Standard Deviation | seconds | baseline, week 4 |
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| Primary | Change in Walking Endurance as Assessed by the 6 Minute Walk Test | The 6 Minute Walk Test assesses the distance walked in 6 minutes. | Posted | Mean | Standard Deviation | feet | baseline, week 4 |
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| Primary | Change in Dynamic Mobility Assessment as Determined by the Timed Up and Go Test | The Timed Up and Go test assessed the time it takes to stand from a sitting position, complete a 3 meter walk, and then return to sitting. | Posted | Mean | Standard Deviation | Second | baseline, week 4 |
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| Primary | Change in Muscle Activity as Assessed by Surface Electromyography (EMG) | Surface EMG sensors will be placed on the skin of subjects' lower extremities and trunk to measure muscle activity. Only one participant data was analyzed. Emg was recorded from the soleus, gastrocnemius, tibialis anterior, rectus femoris, vastus medialis, bicep femoris and semitendinosus muscles. The outcome measure is the %age change between the baseline and 4 week assessments. Negative values denotes decrease in muscle activity at 4 week compared to baseline. | This measure was later added to the protocol and hence data was collected from one participant only. | Posted | Number | percentage of muscle activity change | baseline, week 4 |
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| Primary | Change in Energy Expenditure During Walking as Assessed by Oxygen Cost | Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight.20 Oxygen consumption will be calculated on a breath-by-breath basis measured by a portable metabolic system (Cosmed K4b2). | The metabolic expenditure was only measured for two subjects who completed the Robotic exoskeleton training at the end of the study. The equipment to use metabolic expenditure was not available at that time of enrollment of the population at the beginning of the study. Therefore data was only collected once the equipment became operational. | Posted | Mean | Standard Deviation | ml/min/kg | baseline, week 4 |
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| Secondary | Change in Gait Characteristics as Assessed by the GAITRite Walkway (Cadence) | Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. Cadence is measured as steps/min. Change in cadence is reported as difference between baseline and post assessment. | Posted | Mean | Standard Deviation | steps/min | baseline, week 4 |
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| Secondary | Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Length) | Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. The change in step length between baseline and post assessment is reported. Negative value denotes decrease in step length. | Posted | Mean | Standard Deviation | cm | baseline, week 4 |
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| Secondary | Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Time) | Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. The outcome measure is the difference in step time between pre and post assessment. Negative value denotes decrease in step time (implying faster step time at post). | Posted | Mean | Standard Deviation | seconds | baseline, week 4 |
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| Secondary | Change in Lower Extremity Strength as Assessed by American Spinal Injury Association (ASIA) Lower Extremity Motor Score (LEMS) | The ASIA (American Spinal Injury Association) assessment protocol consists of two sensory examinations, a motor examination and a classification framework (the impairment scale) to quantify the severity of the spinal cord injury. The scale informs about the functionality of the patient. The range of scores is 0 to 5, and high values represent better outcome. Following is the description of the range: 0 = total paralysis
We report the difference between baseline and 4week assessments. Negative value denotes decrease at post assessment. | Posted | Mean | Standard Deviation | units on a scale | baseline, week 4 |
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| Secondary | Exoskeleton User Feedback as Assessed by a Questionnaire | A questionnaire will be administered to allow participants to provide feedback regarding their experiences during training sessions with the exoskeleton. The units on a scale was used to measure the feedback. The range of the scale was 1-5. '1' refers to very satisfied and '5' refers to very dissatisfied. '1' refers to a better outcome. | This measure was only recorded from the participants in the robotic exoskeleton training group. This outcome was mainly related to the feedback of the participants after using the exoskeleton at the end of the training. | Posted | Mean | Standard Deviation | units on a scale | week 4 |
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Adverse event data were collected for each participant during their participation in the study. the study protocol was 1 month long.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Robotic Exoskeleton Training | Robotic exoskeleton training: During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes | 0 | 6 | 0 | 6 | 1 | 6 |
| EG001 | Conventional Physical Therapy | Conventional physical therapy: During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training | 0 | 3 | 0 | 3 | 0 | 3 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| swelling and pain in foot | Musculoskeletal and connective tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chang, Shuo-Hsiu, PT, PhD | UT health PM&R | 713-799-7016 | Shuo-Hsiu.Chang@uth.tmc.edu |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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| >=65 years |
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| Male |
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Conventional physical therapy: During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training |
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