Sensory-Motor Rehabilitation Post Stroke
ConditionAcute Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Maryland, Baltimore
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
stretching and active movement training
DeviceA 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.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Study groupExperimental treatment 1 intervention
Group B: Control groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Changes of Fugl-Meyer Lower Extremity (FMLE)
The assessment is a measure of lower extremity (LE) motor and sensory impairments.
Time frame
At the beginning and end of 3-week training, and 1 month after the treatment endsSecondary outcomes
1
Changes of active range of motion (AROM)
AROM will be measured in degrees in the ankle joint while subjects use the muscles to move the ankle.
Time frame
At the beginning and end of 3-week training, and 1 month after the treatment ends2
Changes of passive range of motion (PROM)
PROM will be measured in degrees in the ankle joint while the robot moves the ankle of the subject strongly.
Time frame
At the beginning and end of 3-week training, and 1 month after the treatment ends3
Changes of ankle strength
Strength of the ankle flexor-extensor muscle will be measured in Newton
Time frame
At the beginning and end of 3-week training, and 1 month after the treatment ends4
Changes of ankle stiffness
Spasticity will be measured by the resistance torque in Newton-meter under controlled movement at each joint.
Time frame
At the beginning and end of 3-week training, and 1 month after the treatment endsSponsors and contacts
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Source ClinicalTrials.gov