Stroke
Conditions
Keywords
Stroke, Paraplegia, Acute
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPassive stretching
Passive stretching under intelligent robotic control
DEVICEGamed-based active movement training
Active movement training through movement games with robotic assistance
DEVICEPassive movement
Passive movement in the joint middle range of motion
DEVICEActive movement training
Active movement training without robotic assistance
DEVICEAnkle torque and motion measurement
Ankle torque and motion measurement with no real-time feedback
DEVICEMotor relearning training
Ankle motor control relearning training under real-time feedback
Sponsors
The University of Texas Health Science Center, Houston
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Randomized clinical trial with the study group and control group
Eligibility
Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Acute first time unilateral hemispheric stroke (hemorrhagic or ischemic stroke, 24 hours after admission to 1 month post-stroke at the start of the proposed treatment) * Hemiplegia or hemiparesis * 0≤Manual Muscle Testing (MMT)\<=2 * Age 30-85 * Ankle impairments including stiff calf muscles and/or inadequate dorsiflexion
Exclusion criteria
* Medically not stable * Associated acute medical illness that interferes with ability to training and exercise * No impairment or very mild ankle impairment of ankle * Severe cardiovascular problems that interfere with ability to perform moderate movement exercises * Cognitive impairment or aphasia with inability to follow instructions * Severe pain in legs * Severe ankle contracture greater than 15° plantar flexion (when pushing ankle to dorsiflexion) * Pressure ulcer, recent surgical incision or active skin disease with open wounds present below knee
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Lower Extremity (FMLE) | At the beginning and end of 3-week training, and 1 month after the treatment ends] | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Passive Range of Motion PROM will be measured in degrees in the ankle joint while the robot moves the ankle of the subject strongly. |
| 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 | Strength of the ankle flexor-extensor muscle will be measured in Newtons |
| Active range of motion (AROM) | At the beginning and end of 3-week training, and 1 month after the treatment ends | AROM will be measured in degrees in the ankle joint while subjects use the muscles to move the ankle. |
| Berg Balance Scale | At the beginning and end of 3-week training, and 1 month after the treatment ends | 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. |
| 10-meter Walk Test | At the beginning and end of 3-week training, and 1 month after the treatment ends | 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. |
| Modified Ashworth Scale (MAS) | At the beginning and end of 3-week training, and 1 month after the treatment ends | 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. |
Countries
United States
Contacts
Primary ContactSoh-Hyun Hur
Outcome results
None listed