Recruiting
Phase 1
Phase 2

Rehabilitation Robot

Sponsor:

University of Maryland, Baltimore

Code:

NCT06404268

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Motor relearning training

Passive stretching

Gamed-based active movement training

Passive movement

Active movement training

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-stroke including patients who are paralyzed with no motor output. The early acute stroke rehabilitation device will be evaluated in this clinical trial.

Conditions

Stroke

Study ID

NCT06404268

Start date

Jun 1, 2025

Status verified date

Jul, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 31, 2028

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

68 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Study group - Wearable ankle robot rehab

Wearable rehab robot with motor relearning with real-time feedback, passive stretching under intelligent control; Active movement training with robotic assistance

active comparator: Control group - Limited wearable ankle 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

Ankle motor control relearning training under real-time feedback

Passive stretching

Passive stretching under intelligent robotic control

Gamed-based active movement training

Active movement training through movement games with robotic assistance

Passive movement

Passive movement in the joint middle range of motion

Active movement training

Active movement training without robotic assistance

Ankle torque and motion measurement

Ankle 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

Peiwen Fu, BS

410 706-8625Peiwen.Fu@som.umaryland.edu

Locations

University of Maryland Baltimore

Recruiting

Baltimore, Maryland, United States, 21201

Principal Investigator:

Li-Qun Larry Zhang, PhD

UMROI

Recruiting

Baltimore, Maryland, United States, 21207

TIRR Memorial Hermann

Recruiting

Houston, Texas, United States, 77030

Contacts

Manuel Portilla-Jimenez, PhD

346-719-4921manuel.a.portillajimenez@uth.tmc.edu

Principal Investigator:

Sheng Li, MD-PhD

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Keywords

  • Stroke
  • Paraplegia
  • Acute

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-07-23.