Recruiting

Rehabilitation Robot

Sponsor:

University of Maryland, Baltimore

Code:

NCT06465290

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Motor relearning training with wearable ankle robot

Passive stretching with wearable ankle robot

Gamed-based active movement training with wearable ankle robot

Passive movement with limited wearable ankle robot

Active movement training with limited wearable ankle robot

Study Details

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.

Conditions

Traumatic Brain Injury

Study ID

NCT06465290

Start date

Jul 16, 2026

Status verified date

Jul, 2026

Completion date

Aug 31, 2030

Anticipated

Primary completion date

Aug 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Motor relearning training with wearable ankle robot

Ankle motor control relearning training under real-time feedback

Passive stretching with wearable ankle robot

Passive stretching under intelligent robotic control

Gamed-based active movement training with wearable ankle robot

Active movement training through movement games with robotic assistance

Passive movement with limited wearable ankle robot

Passive movement in the joint middle range of motion

Active movement training with limited wearable ankle robot

Active movement training without robotic assistance

Ankle/Wrist torque and motion measurement with limited wearable ankle/wrist robot

Ankle/Wrist torque and motion measurement with no real-time feedback

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 and Locations

Central contacts

Soh-Hyun Hur

410 706-8625SoHur@som.umaryland.edu

Locations

Li-Qun Zhang

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Li-Qun Zhang, PhD

4107062145l-zhang@som.umaryland.edu

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Keywords

  • Traumatic Brain Injury (TBI)
  • Paraplegia
  • Acute

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-07-17. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.