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| Name | Class |
|---|---|
| The University of Texas Health Science Center, Houston | OTHER |
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This project will develop a wearable rehabilitation robot suitable for in-bed acute stage rehabilitation. It involves robot-guided motor relearning, passive and active motor-sensory rehabilitation early in the acute stage post-stroke including patients who are paralyzed with no motor output. The early acute stroke rehabilitation device will be evaluated in this clinical trial.
Stroke survivors often experience loss of motor control and impaired function. Immediately after stroke, there is a time-limited window of heightened plasticity during which the greatest gains in recovery occur. Therefore, early intensive sensorimotor rehabilitation post-stroke is critical in improving functional outcomes and minimizing disability. However, acute stroke survivors often receive little active training to improve mobility during their hospital stay and they are left alone during most of the day. Especially for those acute patients with no voluntary motor output, active motor training might be even less, partly due to a lack of rehabilitation protocols to detect potential motor recovering signals sensitively and facilitate neuroplastic changes. To address this unmet clinical need, this project will develop a novel wearable rehabilitation robot suitable for in-bed acute stage rehabilitation with guided motor relearning, passive and active motor-sensory rehabilitation early in the acute stage post-stroke including patients who are paralyzed with no motor output. The early acute stroke rehabilitation device will be evaluated in this clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group - Wearable ankle robot rehab | Experimental | Wearable rehab robot with motor relearning with real-time feedback, passive stretching under intelligent control; Active movement training with robotic assistance |
|
| Control group - Limited wearable ankle robot rehab | Active Comparator | The same wearable robot used by the study group will be used for the control group but in a limited way: no motor relearning training under real-time feedback; passive movement in the joint middle range of motion instead of passive stretching; active movement training with no robotic assistance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motor relearning training | Device | Ankle motor control relearning training under real-time feedback |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Lower Extremity (FMLE) | The Fugl-Meyer Lower Extremity (FMLE) assessment is a measure of lower extremity (LE) motor and sensory impairments. The FMLE scale ranges from 0 to 34, with higher scores indicating better motor function. | At the beginning and end of 3-week training, and 1 month after the treatment ends] |
| Measure | Description | Time Frame |
|---|---|---|
| Active range of motion (AROM) | AROM will be measured in degrees in the ankle joint while subjects use the muscles to move the ankle. | At the beginning and end of 3-week training, and 1 month after the treatment ends |
| Passive Range of Motion (PROM) will be measured in degrees in the ankle joint while the robot moves the ankle of the subject strongly. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Soh-Hyun Hur | Contact | 410 706-8625 | SoHur@som.umaryland.edu |
| Name | Affiliation | Role |
|---|---|---|
| Li-Qun Zhang | University of Maryland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland Baltimore | Recruiting | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34665733 | Background | Zhang C, Huang MZ, Kehs GJ, Braun RG, Cole JW, Zhang LQ. Intensive In-Bed Sensorimotor Rehabilitation of Early Subacute Stroke Survivors With Severe Hemiplegia Using a Wearable Robot. IEEE Trans Neural Syst Rehabil Eng. 2021;29:2252-2259. doi: 10.1109/TNSRE.2021.3121204. Epub 2021 Nov 4. | |
| 22466792 | Background |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D010264 | Paraplegia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D052580 | Muscle Stretching Exercises |
| D016059 | Range of Motion, Articular |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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Randomized clinical trial with the study group and control group
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| Passive stretching | Device | Passive stretching under intelligent robotic control |
|
| Gamed-based active movement training | Device | Active movement training through movement games with robotic assistance |
|
| Passive movement | Device | Passive movement in the joint middle range of motion |
|
| Active movement training | Device | Active movement training without robotic assistance |
|
| Ankle torque and motion measurement | Device | Ankle torque and motion measurement with no real-time feedback |
|
Passive Range of Motion PROM will be measured in degrees in the ankle joint while the robot moves the ankle of the subject strongly. |
| At the beginning and end of 3-week training, and 1 month after the treatment ends |
| Strength of the ankle flexor-extensor muscle will be measured in Newtons | Strength of the ankle flexor-extensor muscle will be measured in Newtons | At the beginning and end of 3-week training, and 1 month after the treatment ends |
| Modified Ashworth Scale (MAS) | The Modified Ashworth Scale is the most widely used assessment tool to measure resistance to limb movement in a clinic setting. Scores range from 0-4, with 6 choices. 0 (0) - No increase in muscle tone; 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension; 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM (range of movement); 2 (3) - More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved; 3 (4) - Considerable increase in muscle tone passive, movement difficult; 4 (5) - Affected part(s) rigid in flexion or extension. | At the beginning and end of 3-week training, and 1 month after the treatment ends |
| Berg Balance Scale | The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. The Berg balance scale ranges from 0 to 56. It is a 14-item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function. | At the beginning and end of 3-week training, and 1 month after the treatment ends |
| 10-meter Walk Test | The 10 Meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance at the beginning and end of 3-week training, and 1 month after the treatment ends. It can be employed to determine functional mobility and gait function. | At the beginning and end of 3-week training, and 1 month after the treatment ends |
| UMROI | Recruiting | Baltimore | Maryland | 21207 | United States |
|
| Krakauer JW, Carmichael ST, Corbett D, Wittenberg GF. Getting neurorehabilitation right: what can be learned from animal models? Neurorehabil Neural Repair. 2012 Oct;26(8):923-31. doi: 10.1177/1545968312440745. Epub 2012 Mar 30. |
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| 20132137 | Background | Wu YN, Ren Y, Goldsmith A, Gaebler D, Liu SQ, Zhang LQ. Characterization of spasticity in cerebral palsy: dependence of catch angle on velocity. Dev Med Child Neurol. 2010 Jun;52(6):563-9. doi: 10.1111/j.1469-8749.2009.03602.x. Epub 2010 Jan 28. |
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| 23063880 | Background | Yang CY, Guo X, Ren Y, Kang SH, Zhang LQ. Position-dependent, hyperexcitable patellar reflex dynamics in chronic stroke. Arch Phys Med Rehabil. 2013 Feb;94(2):391-400. doi: 10.1016/j.apmr.2012.09.029. Epub 2012 Oct 11. |
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| 3588947 | Background | Jenkins WM, Merzenich MM. Reorganization of neocortical representations after brain injury: a neurophysiological model of the bases of recovery from stroke. Prog Brain Res. 1987;71:249-66. doi: 10.1016/s0079-6123(08)61829-4. No abstract available. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |