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Wrist-worn Sensors for Tele-Rehabilitation of the Hemiparetic Upper Extremity

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ClinicalTrials.gov Identifier: NCT03431025
Recruitment Status : Recruiting
First Posted : February 13, 2018
Last Update Posted : March 2, 2021
Sponsor:
Collaborator:
Spaulding Rehabilitation Hospital
Information provided by (Responsible Party):
BioSensics

Study Description
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Brief Summary:
Stroke and other causes of central nervous system damage can result in debilitating loss of motor control that is often more pronounced in one limb than the other. Using or attempting to use the affected limb during activities of daily living, despite considerable difficulty, stimulates neuroplasticity and motor function recovery. The investigators are conducting a clinical study to test the efficacy of wrist-worn sensors that encourage affected limb use during activities of daily living.

Condition or disease Intervention/treatment Phase
Stroke Hemiparesis Device: Wearable sensors and biofeedback Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Wrist-worn Sensors for Tele-Rehabilitation of the Hemiparetic Upper Extremity; A Feasibility Study
Actual Study Start Date : March 28, 2019
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control
Participants in the Control Arm will wear sensors to monitor their upper limb movement but will not receive feedback from these sensors to encourage usage of the impaired limb during activities of daily living.
Experimental: Intervention
Participants in the Experimental Arm will wear sensors to monitor their upper limb movement and will receive feedback from these sensors to encourage usage of the impaired limb during activities of daily living.
 Device: Wearable sensors and biofeedback
Participants in the Experimental Arm will wear sensors to monitor their upper limb movement and will receive feedback from these sensors to encourage usage of the impaired limb during activities of daily living.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Fugl-Meyer during intervention [ Time Frame: 12 weeks ]
    Change in Fugl-Meyer Upper Extremity Assessment Scale score from baseline (measure of upper extremity impairment, score range from 0 to 66 points, higher values are considered a better outcome).

  2. Change in Motor Activity Log Quality Score during intervention [ Time Frame: 12 weeks ]
    Change in Motor Activity Log Quality Score from baseline (measure of hemiparetic upper extremity use in daily life, score range from 0 to 5 points, higher values are considered a better outcome)

  3. Change in Motor Activity Log Quantity Score during intervention [ Time Frame: 12 weeks ]
    Change in Motor Activity Log Quantity Score from baseline (measure of hemiparetic upper extremity use in daily life, score range from 0 to 5 points, higher values are considered a better outcome)

  4. Change in Fugl-Meyer during washout [ Time Frame: 12 weeks (end of intervention), 20 weeks (follow-up) ]
    Change in Fugl-Meyer Upper Extremity Assessment Scale score from end of intervention to follow-up (measure of upper extremity impairment, score range from 0 to 66 points, higher values are considered a better outcome).

  5. Change in Motor Activity Log Quality Score during washout [ Time Frame: 12 weeks (end of intervention), 20 weeks (follow-up) ]
    Change in Motor Activity Log Quality Score from end of intervention to follow-up (measure of hemiparetic upper extremity use in daily life, score range from 0 to 5 points, higher values are considered a better outcome)

  6. Change in Motor Activity Log Quantity Score during washout [ Time Frame: 12 weeks (end of intervention), 20 weeks (follow-up) ]
    Change in Motor Activity Log Quantity Score from end of intervention to follow-up (measure of hemiparetic upper extremity use in daily life, score range from 0 to 5 points, higher values are considered a better outcome)


Secondary Outcome Measures :
  1. Change in Wolf Motor Function Test time-subscale during intervention [ Time Frame: 12 weeks ]
    Change in Wolf Motor Function Test time-subscale score from baseline (measure of upper extremity function, score range from 0 to 120 seconds, lower values are considered a better outcome)

  2. Change in Wolf Motor Function Test quality-subscale during intervention [ Time Frame: 12 weeks ]
    Change in Wolf Motor Function Test quality-subscale score from baseline (measure of upper extremity function, score range from 0 to 5 points, higher values are considered a better outcome)

  3. Change in Wolf Motor Function Test time-subscale during washout [ Time Frame: 12 weeks (end of intervention), 20 weeks (follow-up) ]
    Change in Wolf Motor Function Test time-subscale score from end of intervention to follow-up (measure of upper extremity function, score range from 0 to 120 seconds, lower values are considered a better outcome)

  4. Change in Wolf Motor Function Test quality-subscale during washout [ Time Frame: 12 weeks (end of intervention), 20 weeks (follow-up) ]
    Change in Wolf Motor Function Test quality-subscale score from end of intervention to follow-up (measure of upper extremity function, score range from 0 to 5 points, higher values are considered a better outcome)


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ischemic or hemorrhagic stroke at least 3 months prior to study enrollment
  • Mild-to-moderate to severe upper-limb motor impairments (as measured by a score between 21 and 50 on the arm section of the Fugl-Meyer scale).

Exclusion Criteria:

  • Cognitive impairments that would significantly interfere with their ability to follow instructions (as measured by a score lower than 23 on the Mini Mental State Examination scale)
  • Severe attention deficits or hemispatial neglect (as measured by the Mesulam Cancellation test and the Line Bisection test);
  • Severe range-of-motion limitations (as measured via physical examination) or severe spasticity (as measured using the Modified Ashworth scale) that would prevent safe performance of home-based exercises;
  • Proprioceptive deficits that impair their ability to process feedback (as measured using the Fugl-Meyer Assessment-upper extremity; sensory section).
  • Implantable medical devices that are not compliant with the ISO 14117:2012 and/or ANSI/AAMI PC69 standards for Bluetooth compatibility. We will ask subjects to provide us with their medical device record card and verify that the device complies with the above-mentioned standards. If not, they will be excluded from the study.
  • Participation in upper-extremity rehabilitation program (i.e. outpatient occupational therapy, research study, ...).
  • Recent (< 3 months) Botox injection in the upper-extremity or plan to undergo injections during the study timeline.
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): NCT03431025


Contacts
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Contact: Catherine Adans-Dester, PT 617-952-6321 cadans-dester@partners.org

Locations
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United States, Massachusetts
Spaulding Rehabilitation Hospital Recruiting
Charlestown, Massachusetts, United States, 02129
Contact: Catherine Adans-Dester, PT    617-952-6321    cadans-dester@partners.org   
Sponsors and Collaborators
BioSensics
Spaulding Rehabilitation Hospital
Investigators
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Principal Investigator: Joseph T Gwin, PhD BioSensics LLC
Principal Investigator: Paolo Bonato, PhD Spaulding Rehabilitation Hospital
More Information
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Responsible Party: BioSensics
ClinicalTrials.gov Identifier: NCT03431025    
Other Study ID Numbers: 2016P001688/SRH
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: March 2, 2021
Last Verified: February 2021
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
Additional relevant MeSH terms:
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Paresis
Neurologic Manifestations
Nervous System Diseases