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Sensory-Motor Rehabilitation Post Stroke

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ClinicalTrials.gov Identifier: NCT02369770
Recruitment Status : Recruiting
First Posted : February 24, 2015
Last Update Posted : January 27, 2023
Sponsor:
Collaborators:
Northwestern University
Northwestern Memorial Hospital
Information provided by (Responsible Party):
Li-Qun Zhang, University of Maryland, Baltimore

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Stroke Device: stretching and active movement training Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sensory-Motor Rehabilitation Post Stroke
Actual Study Start Date : April 26, 2019
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
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Arm Intervention/treatment
Experimental: Study group
Subjects in the Study group will receive stretching and active movement training with robotic guidance and intelligent control
 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.
Experimental: Control group
Subjects in the Control group will receive stretching and active movement training without robotic guidance.
 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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02369770


Contacts
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Contact: Michael Graziano, Ph.D. (410) 706-1584 Michael.Graziano@som.umaryland.edu
Contact: Mei Huang, Ph.D. (410) 706-4527 MHuang@som.umaryland.edu

Locations
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United States, Maryland
University of Maryland, Baltimore Recruiting
Baltimore, Maryland, United States, 21201
Contact: Mei Huang, Ph.D.    410-706-4527    MHuang@som.umaryland.edu   
Contact: Michael Graziano, Ph.D.    (410) 706-1584    Michael.Graziano@som.umaryland.edu   
Principal Investigator: Li-Qun Zhang, Ph.D.         
Sponsors and Collaborators
University of Maryland, Baltimore
Northwestern University
Northwestern Memorial Hospital
Investigators
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Principal Investigator: Li-Qun Zhang, Ph.D. University of Maryland, Baltimore
More Information
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Publications:
Jin D, Ren Y, Chen K, Harvey RL, Roth EJ, Prabhakaran S, and Zhang L-Q. Mobility rehabilitation in acute stroke using a wearable ankle robot. Neuroscience, Chicago, 2015

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Responsible Party: Li-Qun Zhang, Principal Investigator, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT02369770    
Other Study ID Numbers: HP-00080466
First Posted: February 24, 2015    Key Record Dates
Last Update Posted: January 27, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Li-Qun Zhang, University of Maryland, Baltimore:
Acute Stroke
Robotic therapy
Ankle impairment
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases