Skip to main content
OpenTrials
Completed

NCT Number: NCT03416842

Home Exercise With Wearable Sensors

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Burke Medical Research Institute

White Plains, New York, 10605, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Number of treatment days completed

    Time frame: 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.

  2. Change in active range of motion of shoulder, elbow, and wrist

    Time frame: From day 1 to day 30 of intervention

    Maximum angular position about a joint that the participant can reach without assistance.

Secondary outcomes

  1. Change in Fugl Meyer upper extremity assessment

    Time frame: From day 1 to day 30 of intervention

    Clinical scale that measures upper extremity impairment in stroke patients

  2. Physical Activity Enjoyment Scale

    Time frame: Day 30 of intervention

    Survey of how well a participant enjoyed the study treatment.

  3. System usability survey

    Time frame: Day 30 of intervention

    Survey of user-friendliness of software and device

Sponsors and collaborators

Lead sponsor

Burke Medical Research Institute

Other

Collaborators

  • 4D Motion Sports

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 31, 2018
Registry last updated
Jul 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.