Home Exercise With Wearable Sensors

NCT03416842 | Completed Phase 1

• 1 other identifier: BRC559
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Hemiparesis

Keywords

outpatient; wearable sensors; home exercise

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change in Fugl Meyer upper extremity assessment

  From day 1 to day 30 of intervention

• Physical Activity Enjoyment Scale

  Day 30 of intervention

• System usability survey

  Day 30 of intervention

Study Arms (1)

Training with 4D Motion Capture Device

EXPERIMENTAL

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

Interventions

Training with 4D Motion Capture Device 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.

Training with 4D Motion Capture Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Burke Medical Research Institute: lead
• 4D Motion Sports: collaborator

Study Sites (1)

Burke Medical Research Institute

White Plains, New York, 10605, United States

Location

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: January 31, 2018
• Study Start: February 1, 2018
• Primary Completion: June 27, 2018
• Study Completion: December 31, 2018
• Last Updated: July 10, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)