Interactive Telehealth for Wheelchair Users

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Brief Title

Interactive Telehealth for Wheelchair Users

Official Title

Interactive Telehealth and Auto-Biofeedback Sensor System for Individuals Who Use a Wheelchair: Phase II

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.
    

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 Type

Interventional


Primary Outcome

Recurrence of Pressure Ulcer

Secondary Outcome

 Change in Patient Health Questionnaire-9 score

Condition

Spinal Cord Injuries

Intervention

An interactive telehealth monitoring and biofeedback system

Study Arms / Comparison Groups

 An interactive telehealth monitoring and biofeedback system
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

50

Start Date

March 2020

Completion Date

January 2022

Primary Completion Date

April 2021

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Sara Mulroy, PhD, PT, 562-385-7177, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04266808

Organization ID

5R44AG059275-04

Secondary IDs

5R44AG059275-04

Responsible Party

Principal Investigator

Study Sponsor

Rancho Research Institute, Inc.

Collaborators

 BioSensics

Study Sponsor

Sara Mulroy, PhD, PT, Principal Investigator, Rancho Los Amigos National Rehab Ce


Verification Date

February 2020