Recruiting

Sensory-Motor Rehabilitation

Sponsor:

University of Maryland, Baltimore

Code:

NCT02369770

Conditions

Acute Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

stretching and active movement training

Study Details

Brief summary:

Early after stroke, patients often have significant motor impairment and sensory deficit. Evidence has demonstrated heightened plasticity and significant recovery in the acute phase (first months) post stroke but there has been a lack of effective and practical protocols and devices for early intensive sensorimotor therapy.This research study will conduct a randomized clinical trial of an intensive motor-sensory rehabilitation on patients with acute stroke using a wearable rehabilitation robot. The primary aims are to facilitate sensorimotor recovery, reduce ankle impairments, and improve balance and gait functions. This clinical trial will be conducted on the Study and Control groups of acute stroke survivors.

Conditions

Acute Stroke

Study ID

NCT02369770

Start date

Apr 26, 2019

Status verified date

Apr, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. First time unilateral acute stroke, hemorrhagic or ischemic, 24 hours after admission in hospital to 1 year post stroke.
2. Hemiplegia or hemiparesis
3. Age 18-80
4. Ankle impairments

Exclusion Criteria:

1. No impairment or very mild ankle impairment of ankle.
2. Unstable medical conditions that interferes with ability to training and exercise.
3. Severe cardiovascular disorders that interfere with ability to perform moderate movement exercises.
4. Cognitive impairment or aphasia with inability to follow instructions
5. Pressure ulcer, recent surgical incision or active skin disease with open wounds present below knee of treated limb
6. Severe pain in legs

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Study group

Subjects in the Study group will receive stretching and active movement training with robotic guidance and intelligent control

experimental: Control group

Subjects in the Control group will receive stretching and active movement training without robotic guidance.

Interventions

stretching and active movement training

A portable rehabilitation robot will be used to strongly or gently move the impaired ankle joint back and forth. Then subjects will be asked to use muscles to move the ankle with or without the robotic guidance depending on which group the subjects are in.

Primary outcome measure

  • Changes of 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

Raziyeh Baghi, Ph.D.

(410) 706-5717rbaghi@som.umaryland.edu

Thanh Phan, PhD

(410) 706-3242Thanh.Phan@som.umaryland.edu

Locations

University of Maryland, Baltimore

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Mei Huang, Ph.D.

(410) 706-4527MHuang@som.umaryland.edu

Michael Graziano, Ph.D.

(410) 706-1584Michael.Graziano@som.umaryland.edu

Principal Investigator:

Li-Qun Zhang, Ph.D.

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Apr 21, 2026

Last verified

Apr, 2026

Keywords

  • Acute Stroke
  • Robotic therapy
  • Ankle impairment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-04-21.