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

Primary Purpose

Stroke, Hemiparesis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wearable sensors and biofeedback
Sponsored by
BioSensics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Spaulding Rehabilitation HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Fugl-Meyer during intervention
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).
Change in Motor Activity Log Quality Score during intervention
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)
Change in Motor Activity Log Quantity Score during intervention
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)
Change in Fugl-Meyer during washout
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).
Change in Motor Activity Log Quality Score during washout
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)
Change in Motor Activity Log Quantity Score during washout
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

Change in Wolf Motor Function Test time-subscale during intervention
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)
Change in Wolf Motor Function Test quality-subscale during intervention
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)
Change in Wolf Motor Function Test time-subscale during washout
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)
Change in Wolf Motor Function Test quality-subscale during washout
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)

Full Information

First Posted
January 23, 2018
Last Updated
February 26, 2021
Sponsor
BioSensics
Collaborators
Spaulding Rehabilitation Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03431025
Brief Title
Wrist-worn Sensors for Tele-Rehabilitation of the Hemiparetic Upper Extremity
Official Title
Wrist-worn Sensors for Tele-Rehabilitation of the Hemiparetic Upper Extremity; A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 28, 2019 (Actual)
Primary Completion Date
August 31, 2021 (Anticipated)
Study Completion Date
August 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioSensics
Collaborators
Spaulding Rehabilitation Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiparesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Wearable sensors and biofeedback
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Fugl-Meyer during intervention
Description
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).
Time Frame
12 weeks
Title
Change in Motor Activity Log Quality Score during intervention
Description
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)
Time Frame
12 weeks
Title
Change in Motor Activity Log Quantity Score during intervention
Description
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)
Time Frame
12 weeks
Title
Change in Fugl-Meyer during washout
Description
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).
Time Frame
12 weeks (end of intervention), 20 weeks (follow-up)
Title
Change in Motor Activity Log Quality Score during washout
Description
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)
Time Frame
12 weeks (end of intervention), 20 weeks (follow-up)
Title
Change in Motor Activity Log Quantity Score during washout
Description
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)
Time Frame
12 weeks (end of intervention), 20 weeks (follow-up)
Secondary Outcome Measure Information:
Title
Change in Wolf Motor Function Test time-subscale during intervention
Description
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)
Time Frame
12 weeks
Title
Change in Wolf Motor Function Test quality-subscale during intervention
Description
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)
Time Frame
12 weeks
Title
Change in Wolf Motor Function Test time-subscale during washout
Description
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)
Time Frame
12 weeks (end of intervention), 20 weeks (follow-up)
Title
Change in Wolf Motor Function Test quality-subscale during washout
Description
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)
Time Frame
12 weeks (end of intervention), 20 weeks (follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Adans-Dester, PT
Phone
617-952-6321
Email
cadans-dester@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph T Gwin, PhD
Organizational Affiliation
BioSensics
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paolo Bonato, PhD
Organizational Affiliation
Spaulding Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spaulding Rehabilitation Hospital
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Adans-Dester, PT
Phone
617-952-6321
Email
cadans-dester@partners.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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