NCT03416842

Home Exercise With Wearable Sensors

Completed Phase 1 Last updated 10 July 2019

What this trial tests

Phase 1 trial testing Training with 4D Motion Capture Device in Stroke in 6 participants. Completed in 31 December 2018.

Timeline

1 February 2018

Primary endpoint
27 June 2018

31 December 2018

Quick facts

Lead sponsor	Burke Medical Research Institute
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	device feasibility
Enrollment	6
Start date	1 February 2018
Primary completion	27 June 2018
Estimated completion	31 December 2018
Sites	1 location across United States

Drugs / interventions tested

• Training with 4D Motion Capture Device

Conditions studied

• Stroke — all drugs for Stroke →
• Hemiparesis — all drugs for Hemiparesis →

Sponsor

Burke Medical Research Institute

Who can join

18 and older, any sex, with Stroke or Hemiparesis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.