Sensory-Motor Rehabilitation Post Stroke

April 17, 2026 updated by: Li-Qun Zhang, University of Maryland, Baltimore
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will investigate an early intensive rehabilitation in acute stroke for motor relearning, reducing ankle impairments and improving balance and mobility/locomotion functions.

The acute stroke survivor will be randomly placed into two groups. Subjects in the Study group will receive robot-aided motor relearning under real-time feedback, stretching under intelligent control, sensory stimulation, and active movement training with interactive games. Subjects in the Control group will receive passive movement in the middle ROM without intelligent stretching and active movement training without robotic guidance.

For both groups, the therapeutic training will be conducted during 5 hourly sessions (including breaks/transitions between tasks) each week over about 3-week hospital stay. Both groups will also receive the standard of care in the hospital and rehabilitation service. Treatment outcome measures will be obtained through blinded assessments and evaluated before and after training involving biomechanical, neuromuscular and clinical outcome measures. Carry-over effects will be further evaluated 1 month after the treatment ends.

Aim 1: To evaluate biomechanical and neuromuscular changes as defined by the passive and active range of motion (ROM), flexor-extensor muscle strength, joint stiffness, proprioception and reflex excitability, and compare these measures between the two groups. The biomechanical and neuromuscular outcome measures will be obtained through blinded assessments and evaluated before and after training using the wearable rehabilitation robot.

Hypothesis 1: Robot-guided motor relearning, stretching and active movement training (Study group) will improve the biomechanical and neuromuscular outcome measures more than those of the Control group.

Aim 2: To evaluate the clinical outcome measures as defined by Fugl-Meyer score (lower extremity), modified Ashworth scale, Berg balance scale, 10 meter walk test, and to compare between the Study and Control groups.

Hypothesis 2: The Study group will improve the clinical outcome measures more than the Control group.

Study Type

Interventional

Enrollment (Estimated)

140

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

Study Contact Backup

Study Locations

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 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
Subjects in the Study group will receive stretching and active movement training with robotic guidance and intelligent control
Device: 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.
Experimental: Control group
Subjects in the Control group will receive stretching and active movement training without robotic guidance.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The assessment is a measure of lower extremity (LE) motor and sensory impairments.
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
Changes of 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
Changes of passive range of motion (PROM)
Time Frame: At the beginning and end of 3-week training, and 1 month after the treatment ends
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
Changes of ankle strength
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 Newton
At the beginning and end of 3-week training, and 1 month after the treatment ends
Changes of ankle stiffness
Time Frame: At the beginning and end of 3-week training, and 1 month after the treatment ends
Spasticity will be measured by the resistance torque in Newton-meter under controlled movement at each joint.
At the beginning and end of 3-week training, and 1 month after the treatment ends
Changes of 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
Changes of 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. 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 and takes approximately 20 minutes to complete.
At the beginning and end of 3-week training, and 1 month after the treatment ends
Changes of 10 meter Walk Test
Time Frame: At the beginning and end of 3-week training, and 1 month after the treatment ends
The 10 Metre Walk Test is a performance measure used to assess walking speed in metres per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function.
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

Northwestern University
Northwestern Memorial Hospital

Investigators

  • Principal Investigator: Li-Qun Zhang, Ph.D., University of Maryland, Baltimore

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 (Actual)

April 26, 2019

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

February 7, 2015

First Submitted That Met QC Criteria

February 17, 2015

First Posted (Estimated)

February 24, 2015

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00080466

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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