NCT02369770 · University of Maryland, Baltimore
Sensory-Motor Rehabilitation Post Stroke
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- First time unilateral acute stroke, hemorrhagic or ischemic, 24 hours after admission in hospital to 1 year post stroke.
- Hemiplegia or hemiparesis
- Ankle impairments
Exclusion criteria
- 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
Where
- Baltimore, Maryland
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 21, 2026 · Source of record for eligibility and locations