Interactive Telehealth for Wheelchair Users
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04266808|
Recruitment Status : Not yet recruiting
First Posted : February 12, 2020
Last Update Posted : February 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries Paraplegia Pressure Ulcer, Buttock||Device: An interactive telehealth monitoring and biofeedback system Behavioral: Education Control||Not Applicable|
Purpose: The purpose of this study is to evaluate the efficacy of an interactive tele-health monitoring and biofeedback system to establish healthy behaviors and promote self-management of pressure relief maneuvers and physical activity.
Procedures and Course of Study:
Baseline 50 participants will be enrolled. At study entry participants will complete four baseline questionnaires and have a Nurse Practitioner or Physician's Assistant inspect their ischial skin to ensure that their prior ulcer is fully healed. A pressure-sensing mat (PRESS) will be placed under their wheelchair cushion, and a wheelchair propulsion motion sensor (WAMS) will be placed on the rear wheel of their wheelchair. The PRESS and WAMS sensors will record participants' pressure relief and wheelchair propulsion activity for the next two weeks.
Participants will then return to the clinic and the study physical therapist will provide all participants with education on importance of pressure relief maneuvers and physical activity for health as well as training in the 3 styles of pressure relief (forward and side leans, depression raise) and shoulder strengthening exercises to protect against shoulder impingement and pain with increased pressure relief and wheelchair propulsion activity. The study physical therapist will then assist all participants in setting goals to increase pressure relief frequency and/or duration and wheelchair propulsion pushes for the future based on their baseline activity. Participants will be randomized into one of two groups: feedback and no feedback. In both groups pressure relief and wheelchair propulsion activity will be recorded by the PRESS and WAMS sensors for the 12 months. Those participants in the no-feedback group will have the feedback features of the system disabled. Those participants in the feedback group will receive instant visual feedback on pressure relief duration and daily summary charts for both pressure relief and wheelchair propulsion activities.
Every month following the intervention for 12 months, a physical therapist will contact participants by phone to inquire whether their ischial skin integrity has changed and whether they have developed a pressure ulcer. Additionally, all participants will return to the clinic at 3, 6, 9, and 12 months after the intervention and a nurse practitioner will examine their ischial skin and review their medical records to determine if a pressure ulcer has developed. Participants will repeat the 4 questionnaires from the baseline evaluation at each follow-up visit. At the 12 month follow-up visit, participants will return the sensor equipment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized trial with one intervention arm and one control arm.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Outcomes Assessors for both skin integrity and psychosocial measures will be blinded to participants' group allocation|
|Official Title:||Interactive Telehealth and Auto-Biofeedback Sensor System for Individuals Who Use a Wheelchair: Phase II|
|Estimated Study Start Date :||March 2020|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||January 2022|
Experimental: An interactive telehealth monitoring and biofeedback system
Participants in this group will receive feedback of pressure relief maneuvers and wheelchair propulsion activity. Feedback for pressure relief will include information during the activity to identify adequate duration and magnitude of pressure relief activity, reminders of when the next pressure relief is due, and daily aggregate information regarding the number of successful pressure relief maneuvers performed.
Device: An interactive telehealth monitoring and biofeedback system
A pressure sensitive mat located under the user's wheelchair seat cushion and a wheelchair propulsion monitoring device attached to the chair which are interfaced with a phone App based user interface to provide feed back to promote physical activity and pressure relief maneuver performance among wheelchair users.
Sham Comparator: Education Control
Participants will receive education on the importance and recommended frequency of pressure relief maneuver for prevention of pressure ulcer/injury and on the importance and recommended amounts of physical activity for health.
Behavioral: Education Control
Participants will receive education on importance of pressure relief maneuvers and physical activity and the recommended amounts of each for prevention of pressure ulcer/injury and for physical health.
- Recurrence of Pressure Ulcer [ Time Frame: Any time during the one year active phase of the study intervention ]Any stage of Pressure Ulcer/Injury identified in the ischial region
- Change in mean number of cycles of self-propulsion per day from Baseline [ Time Frame: The four weeks preceding the 12 month assessments ]The increase or decrease in number of cycles of self-propulsion per day over the 4 weeks preceding the 12 month assessment
- Change in mean number of pressure relief maneuvers per day from Baseline [ Time Frame: The four weeks preceding the 12 month assessments ]The increase or decrease in mean number of pressure relief maneuvers per day over the 4 weeks preceding the 12 month assessment from Baseline
- Time to Recurrence of Pressure Ulcer [ Time Frame: Any time during the one year active phase of the study intervention ]The number of days from study entry to identification of recurrence of Pressure Ulcer/Injury
- Change in Patient Health Questionnaire-9 score [ Time Frame: 12 months ]Change in Questionnaire scores measuring depressive symptoms at 12 month assessment from baseline score
- Change in University of Washington Self Efficacy Short Form [ Time Frame: 12 months ]Change in scores on Questionnaire measuring self-efficacy at 12 month assessment from baseline score
- Change in Reintegration to Normal Living Index [ Time Frame: 12 months ]Change score on Questionnaire measuring participation at 12 month assessment from baseline score
- Change in Satisfaction with Life Scale [ Time Frame: 12 months ]Change in score on Questionnaire measuring satisfaction with life at 12 month assessment from baseline score
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): NCT04266808
|Contact: Sara Mulroy, PhD, PTemail@example.com|
|United States, California|
|Rancho Los Amigos National Rehabilitaiton Center|
|Downey, California, United States, 90242|
|Contact: Sara Mulroy, PT, DPT 562-385-7177 firstname.lastname@example.org|
|Principal Investigator: Sara J Mulroy, PhD, PT|
|Principal Investigator:||Sara Mulroy, PhD, PT||Rancho Los Amigos National Rehab Ce|