Promoting Neuroplastic Changes of Patients With TBI
NCT Number: NCT06465290
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Traumatic Brain Injury
Interventions: DEVICE: Motor relearning training with wearable ankle robot|DEVICE: Passive stretching with wearable ankle robot|DEVICE: Gamed-based active movement training with wearable ankle robot|DEVICE: Passive movement with limited wearable ankle robot|DEVICE: Active movement training with limited wearable ankle robot|DEVICE: Ankle torque and motion measurement with limited wearable ankle robot
Sponsor: University of Maryland, Baltimore
Collaborators: The University of Texas Health Science Center, Houston
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2030-05-31

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-TBI including patients who are paralyzed with no motor output. The early acute TBI rehabilitation device will be evaluated in this clinical trial.

Primary Outcome Measures: 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]
Secondary Outcome Measures: 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), 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