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Interactive Telehealth for Wheelchair Users

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ClinicalTrials.gov Identifier: NCT04266808
Recruitment Status : Not yet recruiting
First Posted : February 12, 2020
Last Update Posted : February 12, 2020
Sponsor:
Collaborators:
BioSensics
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Sara Mulroy, Rancho Research Institute, Inc.

Study Description
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Brief Summary:
During typical daily activity, people with established spinal cord injury perform significantly fewer pressure-relief maneuvers than the recommended frequency while overestimating their adherence on recall surveys of pressure relief activity. The rate of pressure ulcer recurrence in individuals with a prior ulcer is 44% in those with surgical repair and as high as 75% in those with non-surgical healing indicating that increased attention to pressure relief is critical for these individuals.This study will evaluate the efficacy of a wheelchair sensor and app-based biofeedback for establishing healthy self-management behaviors (pressure relief maneuvers and daily physical activity). Investigators will enroll 50 participants with paraplegia from spinal cord injury who use a manual wheelchair for mobility and have a history of pressure ulcer that has healed or is six months post-surgical repair. Participants will be randomized into one of two groups: an intervention group that will receive an education intervention and the proposed technology to be used for one year, and a control group that will receive only the education intervention. The primary outcome will be pressure ulcer occurrence over one year. Investigators hypothesize that participants receiving the intervention of biofeedback on their pressure relief activity will have a lower recurrence of pressure ulcer than the education only control group. Secondary outcomes include depressive symptoms, self-efficacy, participation and satisfaction with life. Investigators hypothesize that increasing physical activity will reduce depressive symptoms and improve participation and satisfaction with life.

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

Detailed Description:

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.

Intervention:

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.

Follow-up:

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
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
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Change in Reintegration to Normal Living Index [ Time Frame: 12 months ]
    Change score on Questionnaire measuring participation at 12 month assessment from baseline score

  4. 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


Eligibility Criteria
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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:

  • paraplegia from Spinal Cord Injury
  • a history of pressure ulcer that has healed or 6 months post surgical repair
  • use a manual wheelchair for mobility
  • able to perform pressure relief maneuvers independently

Exclusion Criteria:

  • unable/unwilling to return to clinic for follow-up visits
Contacts and Locations
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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): NCT04266808


Contacts
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Contact: Sara Mulroy, PhD, PT 562-385-7177 smulroy@dhs.lacounty.gov

Locations
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United States, California
Rancho Los Amigos National Rehabilitaiton Center
Downey, California, United States, 90242
Contact: Sara Mulroy, PT, DPT    562-385-7177    smulroy@dhs.lacounty.gov   
Principal Investigator: Sara J Mulroy, PhD, PT         
Sponsors and Collaborators
Rancho Research Institute, Inc.
BioSensics
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Sara Mulroy, PhD, PT Rancho Los Amigos National Rehab Ce
More Information
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Responsible Party: Sara Mulroy, Research Director, Rancho Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT04266808    
Other Study ID Numbers: 5R44AG059275-04 ( U.S. NIH Grant/Contract )
5R44AG059275-04 ( U.S. NIH Grant/Contract )
First Posted: February 12, 2020    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
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: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sara Mulroy, Rancho Research Institute, Inc.:
Spinal cord injury
Pressure Ulcer
Additional relevant MeSH terms:
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Spinal Cord Injuries
Paraplegia
Pressure Ulcer
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
 Trauma, Nervous System
Wounds and Injuries
Skin Ulcer
Skin Diseases
Paralysis
Neurologic Manifestations