Clinical trial NCT06465290: Promoting Neuroplastic Changes of Patients With TBI
Official title: Promoting Neuroplastic Changes of Patients With TBI
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Traumatic Brain Injury
Keywords: Traumatic Brain Injury (TBI)
Paraplegia
Acute
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: The University of Texas Health Science Center, Houston
First posted: 2024-06-18
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial with the study group and control group
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Fugl-Meyer Lower Extremity (FMLE)
timeFrame: At the beginning and end of 3-week training, and 1 month after the treatment ends]
Secondary outcomes:
measure: Active range of motion (AROM)
timeFrame: At the beginning and end of 3-week training, and 1 month after the treatment ends
measure: Passive Range of Motion (PROM)
timeFrame: At the beginning and end of 3-week training, and 1 month after the treatment ends
measure: Strength of the ankle flexor-extensor muscle
timeFrame: At the beginning and end of 3-week training, and 1 month after the treatment ends
measure: Modified Ashworth Scale (MAS)
timeFrame: At the beginning and end of 3-week training, and 1 month after the treatment ends
measure: Berg Balance Scale
timeFrame: At the beginning and end of 3-week training, and 1 month after the treatment ends
measure: 10-meter Walk Test
timeFrame: At the beginning and end of 3-week training, and 1 month after the treatment ends
Other outcomes:
Locations:
Study officials:
affiliation: University of Maryland
name: Li-Qun Zhang
role: PRINCIPAL_INVESTIGATOR
References:
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