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Wearable Ankle Robot for Traumatic Brain Injury Rehabilitation

This study is testing different ways to use a wearable ankle robot to help people recover from a traumatic brain injury (TBI). The robot can provide motor relearning training, passive stretching, game-based active movement training, passive movement, and active movement training. This research aims to improve movement and reduce problems like stiff calf muscles or difficulty lifting the foot (inadequate dorsiflexion). You might be able to join if you are 30-85 years old, have had a first-time stroke within the last month, and have weakness or paralysis on one side of your body (hemiplegia or hemiparesis). The study will measure success by looking at changes in your lower body movement using the Fugl-Meyer Lower Extremity (FMLE) score, measured at the beginning, end of a 3-week training, and one month later. The current status of this study is unclear.

Study design
This interventional study plans to enroll 100 participants. It is testing different rehabilitation methods using a wearable ankle robot.
What's involved
Participants will undergo a 3-week training period. Assessments will be done at the beginning and end of this training, and one month after it concludes.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for one month after the treatment ends.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06465290

Promoting Neuroplastic Changes of Patients With TBI

Recruiting
NAAges 30–85InterventionalTreatment
University of Maryland, Baltimore
~100 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:Motor relearning training with wearable ankle robotPassive stretching with wearable ankle robotGamed-based active movement training with wearable ankle robotPassive movement with limited wearable ankle robotActive movement training with limited wearable ankle robotAnkle/Wrist torque and motion measurement with limited wearable ankle/wrist robot

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Fugl-Meyer Lower Extremity (FMLE)
Measured over At the beginning and end of 3-week training, and 1 month after the treatment ends]

Conditions

Traumatic Brain Injury

Explore related trials

Stroke

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Li-Qun Zhang · PRINCIPAL_INVESTIGATOR · University of Maryland

Who to contact

Soh-Hyun Hur
[email protected]
410 706-8625
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • 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.