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Home Exercise With Wearable Sensors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03416842
Recruitment Status : Completed
First Posted : January 31, 2018
Last Update Posted : July 10, 2019
Sponsor:
Collaborator:
4D Motion Sports
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Stroke Hemiparesis Device: Training with 4D Motion Capture Device Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Home-based Exercises Using Wearable Motion Sensors for Community-dwelling Stroke Survivors With Hemiparesis
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : June 27, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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 :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03416842


Locations
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United States, New York
Burke Medical Research Institute
White Plains, New York, United States, 10605
Sponsors and Collaborators
Burke Medical Research Institute
4D Motion Sports
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Responsible Party: Burke Medical Research Institute
ClinicalTrials.gov Identifier: NCT03416842    
Other Study ID Numbers: BRC559
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Burke Medical Research Institute:
outpatient
wearable sensors
home exercise
Additional relevant MeSH terms:
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Paresis
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms