Home Exercise With Wearable Sensors

Home-based Exercises Using Wearable Motion Sensors for Community-dwelling Stroke Survivors With Hemiparesis

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Hemiparesis
• Intervention / Treatment: Device: Training with 4D Motion Capture Device

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • White Plains, New York, United States, 10605
      • Burke Medical Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Training with 4D Motion Capture Device; 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.	Device: Training with 4D Motion Capture Device; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From day 1 to day 30 of intervention
Change in active range of motion of shoulder, elbow, and wrist	Maximum angular position about a joint that the participant can reach without assistance.	From day 1 to day 30 of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fugl Meyer upper extremity assessment	Clinical scale that measures upper extremity impairment in stroke patients	From day 1 to day 30 of intervention
Physical Activity Enjoyment Scale	Survey of how well a participant enjoyed the study treatment.	Day 30 of intervention
System usability survey	Survey of user-friendliness of software and device	Day 30 of intervention

Collaborators and Investigators

• Sponsor: Burke Medical Research Institute
• Collaborators: 4D Motion Sports

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2018
• Primary Completion (ACTUAL): June 27, 2018
• Study Completion (ACTUAL): December 31, 2018

Study Registration Dates

• First Submitted: January 18, 2018
• First Submitted That Met QC Criteria: January 24, 2018
• First Posted (ACTUAL): January 31, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 10, 2019
• Last Update Submitted That Met QC Criteria: July 9, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: outpatient; home exercise; wearable sensors
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paresis
• Other Study ID Numbers: BRC559

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No