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Home Exercise With Wearable Sensors

Primary Purpose

Stroke, Hemiparesis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Training with 4D Motion Capture Device
Sponsored by
Burke Medical Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Stroke focused on measuring outpatient, wearable sensors, home exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Able to follow 1-2 step commands
  • Neurological deficit leading to hemiparesis or hemiplegia with a sensorimotor deficit
  • Fugl Meyer Upper Extremity Score of at least 20/66

Exclusion Criteria:

  • Has a metal implant anywhere on or inside the body
  • Fixed contracture or deformity of affected upper extremity
  • Individuals with bilateral stroke (i.e. if both arms are affected)
  • Unable to tolerate repetitious movement as determined by Likert Scale Rating greater than 5 out of 10

Sites / Locations

  • Burke Medical Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Training with 4D Motion Capture Device

Arm Description

Participants will be given access to a tablet-based application and non-invasive sensors that will track movements of the upper extremity and will prompt daily exercise. Participants will be encouraged to use the device daily for 30 consecutive days, up to one hour per day.

Outcomes

Primary Outcome Measures

Number of treatment days completed
Measure of the number of days that the participant adheres to the prescribed therapy plan (completion of 1000 movements). Goal is to have participants perform 1000 movements per day over 30 days.
Change in active range of motion of shoulder, elbow, and wrist
Maximum angular position about a joint that the participant can reach without assistance.

Secondary Outcome Measures

Change in Fugl Meyer upper extremity assessment
Clinical scale that measures upper extremity impairment in stroke patients
Physical Activity Enjoyment Scale
Survey of how well a participant enjoyed the study treatment.
System usability survey
Survey of user-friendliness of software and device

Full Information

First Posted
January 18, 2018
Last Updated
July 9, 2019
Sponsor
Burke Medical Research Institute
Collaborators
4D Motion Sports
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1. Study Identification

Unique Protocol Identification Number
NCT03416842
Brief Title
Home Exercise With Wearable Sensors
Official Title
Home-based Exercises Using Wearable Motion Sensors for Community-dwelling Stroke Survivors With Hemiparesis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
June 27, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Burke Medical Research Institute
Collaborators
4D Motion Sports

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
Repetitious motor therapy has been shown to yield the greatest improvement in motor function in those who suffer hemiplegia because of a neurological impairment. However, motor therapy remains largely clinically based due to the absence of quantitative home-based therapy technology or equipment. With the current lack of accountability, patient adherence to home exercise physical therapy programs is estimated to be as low as 35%. In response, some companies have extended the applications of their motion capture devices to be used for home-based physical therapy. However, the technologies often have not passed their initial stages of development. In contrast, a company named 4D Motion is actively working alongside the Restorative Neurology Clinic at Burke Medical Research Institute to develop a motion capture system tailored to the motor rehabilitation of hemiplegic stroke patients. This device is driven by a user's active range of motion and does not impart electrical or mechanical stimulation to the user. The device does not force the user beyond their active range of motion and does not apply resistance to motion that limits the user's capability. The 4D Motion capture system is only used to record what the patient is doing and to promote adherence to their prescribed physical therapy plan.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiparesis
Keywords
outpatient, wearable sensors, home exercise

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Training with 4D Motion Capture Device
Arm Type
Experimental
Arm Description
Participants will be given access to a tablet-based application and non-invasive sensors that will track movements of the upper extremity and will prompt daily exercise. Participants will be encouraged to use the device daily for 30 consecutive days, up to one hour per day.
Intervention Type
Device
Intervention Name(s)
Training with 4D Motion Capture Device
Intervention Description
Participants will be given access to a tablet-based application and non-invasive sensors that will track movements of the upper extremity and will prompt daily exercise. Participants will be encouraged to use the device daily for 30 consecutive days, up to one hour per day.
Primary Outcome Measure Information:
Title
Number of treatment days completed
Description
Measure of the number of days that the participant adheres to the prescribed therapy plan (completion of 1000 movements). Goal is to have participants perform 1000 movements per day over 30 days.
Time Frame
From day 1 to day 30 of intervention
Title
Change in active range of motion of shoulder, elbow, and wrist
Description
Maximum angular position about a joint that the participant can reach without assistance.
Time Frame
From day 1 to day 30 of intervention
Secondary Outcome Measure Information:
Title
Change in Fugl Meyer upper extremity assessment
Description
Clinical scale that measures upper extremity impairment in stroke patients
Time Frame
From day 1 to day 30 of intervention
Title
Physical Activity Enjoyment Scale
Description
Survey of how well a participant enjoyed the study treatment.
Time Frame
Day 30 of intervention
Title
System usability survey
Description
Survey of user-friendliness of software and device
Time Frame
Day 30 of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Able to follow 1-2 step commands Neurological deficit leading to hemiparesis or hemiplegia with a sensorimotor deficit Fugl Meyer Upper Extremity Score of at least 20/66 Exclusion Criteria: Has a metal implant anywhere on or inside the body Fixed contracture or deformity of affected upper extremity Individuals with bilateral stroke (i.e. if both arms are affected) Unable to tolerate repetitious movement as determined by Likert Scale Rating greater than 5 out of 10
Facility Information:
Facility Name
Burke Medical Research Institute
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Home Exercise With Wearable Sensors

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