Home Exercise With Wearable Sensors

Phase 1

Completed

• Conditions: Stroke; Hemiparesis
• Interventions: Device: Training with 4D Motion Capture Device

• Registration Number: NCT03416842
• Lead Sponsor: Burke Medical Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-18
• Study First Submitted QC: 2018-01-24
• Study First Posted: 2018-01-31
• Study Start: 2018-02-01
• Primary Completion: 2018-06-27
• Study Completion: 2018-12-31
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-09
• Last Update Posted: 2019-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Training with 4D Motion Capture 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.

Primary Outcome Measures

Name	Time	Method
Number of treatment days completed	From day 1 to day 30 of intervention	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	From day 1 to day 30 of intervention	Maximum angular position about a joint that the participant can reach without assistance.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Burke Medical Research Institute; 🇺🇸 White Plains, New York, United States