Promoting Neuroplastic Changes of Patients With TBI

February 21, 2026 updated by: Li-Qun Zhang, University of Maryland, Baltimore
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Device: Motor relearning training with wearable ankle robot
Ankle motor control relearning training under real-time feedback
Device: Passive stretching with wearable ankle robot
Passive stretching under intelligent robotic control
Device: Gamed-based active movement training with wearable ankle robot
Active movement training through movement games 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
Device: Passive movement with limited wearable ankle robot
Passive movement in the joint middle range of motion
Device: Active movement training with limited wearable ankle robot
Active movement training without robotic assistance
Device: Ankle/Wrist torque and motion measurement with limited wearable ankle/wrist robot
Ankle/Wrist torque and motion measurement with no real-time feedback

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Active range of motion (AROM)
Time Frame: 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.
At the beginning and end of 3-week training, and 1 month after the treatment ends
Modified Ashworth Scale (MAS)
Time Frame: 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.
At the beginning and end of 3-week training, and 1 month after the treatment ends
Berg Balance Scale
Time Frame: 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.
At the beginning and end of 3-week training, and 1 month after the treatment ends
10-meter Walk Test
Time Frame: 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.
At the beginning and end of 3-week training, and 1 month after the treatment ends
Passive Range of Motion (PROM)
Time Frame: 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.
At the beginning and end of 3-week training, and 1 month after the treatment ends
Strength of the ankle flexor-extensor muscle
Time Frame: 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
At the beginning and end of 3-week training, and 1 month after the treatment ends

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Collaborators

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Li-Qun Zhang, University of Maryland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

August 31, 2029

Study Completion (Estimated)

August 31, 2030

Study Registration Dates

First Submitted

May 24, 2024

First Submitted That Met QC Criteria

June 17, 2024

First Posted (Actual)

June 18, 2024

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 21, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00110703

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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