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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-TBI including patients who are paralyzed with no motor output. The early acute TBI rehabilitation device will be evaluated in this clinical trial.
Early after TBI, patients often have significant sensorimotor impairment. There is heightened neural excitability, which may be used to facilitate recovery in the acute phase post stroke. However, there has been a lack of effective and practical protocols and devices for early intensive sensorimotor therapy. The proposed randomized clinical trial using a wearable rehabilitation robot, muscle electromyography (EMG), and/or potentially brain electroencephalogram (EEG) signal seeks to provide early intensive sensorimotor training facilitated by real-time audiovisual and haptic feedback, intelligent stretching and sensory stimulation, active movement training through motivating movement games to promote neuroplasticity and reduce sensorimotor impairments. For acute TBI survivors who cannot generate any motor output yet, EMG or EEG may be used to detect the earliest re-emerging motor control signal and the robot can be used to provide demo and feedback of the intended movement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group - Intensive ankle/hand robot rehab | Experimental | Ankle/Hand robot with motor relearning with real-time feedback, passive stretching under intelligent control; Active movement training with robotic assistance |
|
| Control group - Mild ankle/hand 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 with wearable ankle robot | 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) |
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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 |
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| 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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Randomized clinical trial with the study group and control group
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| Passive stretching with wearable ankle robot | Device | Passive stretching under intelligent robotic control |
|
| Gamed-based active movement training with wearable ankle robot | Device | Active movement training through movement games with robotic assistance |
|
| Passive movement with limited wearable ankle robot | Device | Passive movement in the joint middle range of motion |
|
| Active movement training with limited wearable ankle robot | Device | Active movement training without robotic assistance |
|
| Ankle/Wrist torque and motion measurement with limited wearable ankle/wrist robot | Device | Ankle/Wrist 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 | 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 |
| 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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| 12509602 | Background | Sanger TD, Delgado MR, Gaebler-Spira D, Hallett M, Mink JW; Task Force on Childhood Motor Disorders. Classification and definition of disorders causing hypertonia in childhood. Pediatrics. 2003 Jan;111(1):e89-97. doi: 10.1542/peds.111.1.e89. |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D010264 | Paraplegia |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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 |
| 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 |
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