Sensory-Motor Rehabilitation Post Stroke

NCT02369770 | Recruiting

• 1 other identifier: HP-00080466
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Keywords

Acute Stroke; Robotic therapy; Ankle impairment

Outcome Measures

Primary Outcomes (1)

• Changes of Fugl-Meyer Lower Extremity (FMLE)

  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 Outcomes (7)

• Changes of active range of motion (AROM)

  At the beginning and end of 3-week training, and 1 month after the treatment ends

• Changes of passive range of motion (PROM)

  At the beginning and end of 3-week training, and 1 month after the treatment ends

• Changes of ankle strength

  At the beginning and end of 3-week training, and 1 month after the treatment ends

• Changes of ankle stiffness

  At the beginning and end of 3-week training, and 1 month after the treatment ends

• Changes of Modified Ashworth Scale (MAS)

  At the beginning and end of 3-week training, and 1 month after the treatment ends

Study Arms (2)

Study group

EXPERIMENTAL

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

Device: stretching and active movement training

Control group

EXPERIMENTAL

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

Device: stretching and active movement training

Interventions

stretching and active movement training DEVICE

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.

Control group; Study group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

RECRUITING

Related Publications (31)

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  BACKGROUND

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MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Li-Qun Zhang, Ph.D.

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raziyeh Baghi, Ph.D.

CONTACT

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

Thanh Phan, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 7, 2015
• First Posted: February 24, 2015
• Study Start: April 26, 2019
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)