Sensory-Motor Rehabilitation Post Stroke

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT02369770
Status
Recruiting
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Conditions

  • Acute Stroke

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Apr 26, 2019
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
University of Maryland, BaltimoreBaltimoreMaryland21201
Mei Huang, Ph.D.
[email protected]
(410) 706-4527
Michael Graziano, Ph.D.
[email protected]
(410) 706-1584
Li-Qun Zhang, Ph.D. (PRINCIPAL_INVESTIGATOR)

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