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NCT Number: NCT02369770

Sensory-Motor Rehabilitation Post Stroke

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.

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Key information

Conditions

Acute Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Changes of active range of motion (AROM)

    Time frame: 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.

  2. Changes of passive range of motion (PROM)

    Time frame: 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.

  3. Changes of ankle strength

    Time frame: 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

  4. Changes of ankle stiffness

    Time frame: 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.

  5. Changes of Modified Ashworth Scale (MAS)

    Time frame: 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.

  6. Changes of Berg Balance Scale

    Time frame: 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.

  7. Changes of 10 meter Walk Test

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Raziyeh Baghi, Ph.D.

CONTACT

[email protected]

(410) 706-5717

Thanh Phan, PhD

CONTACT

[email protected]

(410) 706-3242

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Feb 24, 2015
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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