Sensory-Motor Rehabilitation Post Stroke

Not Applicable

Recruiting

• Conditions: Acute Stroke
• Interventions: Device: stretching and active movement training

• Registration Number: NCT02369770
• Lead Sponsor: University of Maryland, Baltimore

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.

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 Timeline

• Study First Submitted: 2015-02-07
• Study First Submitted QC: 2015-02-17
• Study First Posted: 2015-02-24
• Study Start: 2019-04-26
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-14
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	stretching and active movement training	Subjects in the Study group will receive stretching and active movement training with robotic guidance and intelligent control
Control group	stretching and active movement training	Subjects in the Control group will receive stretching and active movement training without robotic guidance.

Primary Outcome Measures

Name	Time	Method
Changes of Fugl-Meyer Lower Extremity (FMLE)	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.

Secondary Outcome Measures

Name	Time	Method
Changes of ankle stiffness	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.
Changes of passive range of motion (PROM)	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.
Changes of active range of motion (AROM)	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.
Changes of Modified Ashworth Scale (MAS)	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.
Changes of ankle strength	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
Changes of Berg Balance Scale	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.
Changes of 10 meter Walk Test	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.

Trial Locations

Locations (1)

University of Maryland, Baltimore; 🇺🇸 Baltimore, Maryland, United States