Home Exercise With Wearable Sensors

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03416842
• Other study ID #: BRC559
• Status: Completed
• Phase: Phase 1
• Start date: February 1, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: July 2019
• Source: Burke Medical Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 31, 2018
• Est. primary completion date: June 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemiparesis
• Paresis
• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	Burke Medical Research Institute	White Plains	New York

Sponsors (2)

Lead Sponsor	Collaborator
Burke Medical Research Institute	4D Motion Sports

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Physical Activity Enjoyment Scale	Survey of how well a participant enjoyed the study treatment.	Day 30 of intervention
Secondary	System usability survey	Survey of user-friendliness of software and device	Day 30 of intervention