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NCT Number: NCT06465290

Promoting Neuroplastic Changes of Patients With TBI

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.

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Key information

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Li-Qun Zhang

Baltimore, Maryland, 21201, United States

Location status: Recruiting

Location contact

Li-Qun Zhang, PhD

CONTACT

[email protected]

4107062145

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Soh-Hyun Hur

CONTACT

[email protected]

410 706-8625

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • The University of Texas Health Science Center, Houston

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Jun 18, 2024
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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