Promoting Neuroplastic Changes of Patients With TBI

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT06465290
Status
Recruiting
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Conditions

  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
30 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Motor relearning training with wearable ankle robot — DEVICE
    Ankle motor control relearning training under real-time feedback
  • 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

Study Details

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.

Key Dates

First listed
Jun 18, 2024
Start date
Jul 16, 2026
Status verified
Jul 2026
Primary completion
Aug 31, 2029
Completion
Aug 31, 2030

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Study group - Intensive ankle/hand robot rehab
    Ankle/Hand robot with motor relearning with real-time feedback, passive stretching under intelligent control; Active movement training with robotic assistance
  • Active Comparator: Control group - Mild ankle/hand robot rehab
    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

Primary Outcome Measure

Fugl-Meyer Lower Extremity (FMLE) [ Time Frame: At the beginning and end of 3-week training, and 1 month after the treatment ends] ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Li-Qun ZhangBaltimoreMaryland21201
Li-Qun Zhang, PhD
[email protected]
4107062145

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Li-Qun Zhang· Baltimore, MD

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