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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
68
Ankle motor control relearning training under real-time feedback
Passive stretching under intelligent robotic control
Active movement training through movement games with robotic assistance
University of Maryland Baltimore
Baltimore, Maryland, United States
RECRUITINGUMROI
Baltimore, Maryland, United States
RECRUITINGTIRR Memorial Hermann
Houston, Texas, United States
RECRUITINGFugl-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.
Time frame: At the beginning and end of 3-week training, and 1 month after the treatment ends]
Active range of motion (AROM)
AROM will be measured in degrees in the ankle joint while subjects use the muscles to move the ankle.
Time frame: 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.
Passive Range of Motion PROM will be measured in degrees in the ankle joint while the robot moves the ankle of the subject strongly.
Time frame: 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
Time frame: 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.
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Passive movement in the joint middle range of motion
Active movement training without robotic assistance
Ankle torque and motion measurement with no real-time feedback
Time frame: 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.
Time frame: 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.
Time frame: At the beginning and end of 3-week training, and 1 month after the treatment ends