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Interactive Telehealth for Wheelchair Users

Primary Purpose

Spinal Cord Injuries, Paraplegia, Pressure Ulcer, Buttock

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
An interactive telehealth monitoring and biofeedback system
Education Control
Sponsored by
Rancho Research Institute, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spinal Cord Injuries focused on measuring Spinal cord injury, Pressure Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rancho Los Amigos National Rehabilitaiton Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

An interactive telehealth monitoring and biofeedback system

Education Control

Arm 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.

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.

Outcomes

Primary Outcome Measures

Recurrence of Pressure Ulcer
Any stage of Pressure Ulcer/Injury identified in the ischial region
Change in mean number of cycles of self-propulsion per day from Baseline
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
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
The number of days from study entry to identification of recurrence of Pressure Ulcer/Injury

Secondary Outcome Measures

Change in Patient Health Questionnaire-9 score
Change in Questionnaire scores measuring depressive symptoms at 12 month assessment from baseline score
Change in University of Washington Self Efficacy Short Form
Change in scores on Questionnaire measuring self-efficacy at 12 month assessment from baseline score
Change in Reintegration to Normal Living Index
Change score on Questionnaire measuring participation at 12 month assessment from baseline score
Change in Satisfaction with Life Scale
Change in score on Questionnaire measuring satisfaction with life at 12 month assessment from baseline score

Full Information

First Posted
February 7, 2020
Last Updated
February 10, 2020
Sponsor
Rancho Research Institute, Inc.
Collaborators
BioSensics, National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT04266808
Brief Title
Interactive Telehealth for Wheelchair Users
Official Title
Interactive Telehealth and Auto-Biofeedback Sensor System for Individuals Who Use a Wheelchair: Phase II
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 2020 (Anticipated)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rancho Research Institute, Inc.
Collaborators
BioSensics, National Institute on Aging (NIA)

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Paraplegia, Pressure Ulcer, Buttock
Keywords
Spinal cord injury, Pressure Ulcer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized trial with one intervention arm and one control arm.
Masking
Outcomes Assessor
Masking Description
Outcomes Assessors for both skin integrity and psychosocial measures will be blinded to participants' group allocation
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
An interactive telehealth monitoring and biofeedback system
Arm Type
Experimental
Arm 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.
Arm Title
Education Control
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
An interactive telehealth monitoring and biofeedback system
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Education Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recurrence of Pressure Ulcer
Description
Any stage of Pressure Ulcer/Injury identified in the ischial region
Time Frame
Any time during the one year active phase of the study intervention
Title
Change in mean number of cycles of self-propulsion per day from Baseline
Description
The increase or decrease in number of cycles of self-propulsion per day over the 4 weeks preceding the 12 month assessment
Time Frame
The four weeks preceding the 12 month assessments
Title
Change in mean number of pressure relief maneuvers per day from Baseline
Description
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 Frame
The four weeks preceding the 12 month assessments
Title
Time to Recurrence of Pressure Ulcer
Description
The number of days from study entry to identification of recurrence of Pressure Ulcer/Injury
Time Frame
Any time during the one year active phase of the study intervention
Secondary Outcome Measure Information:
Title
Change in Patient Health Questionnaire-9 score
Description
Change in Questionnaire scores measuring depressive symptoms at 12 month assessment from baseline score
Time Frame
12 months
Title
Change in University of Washington Self Efficacy Short Form
Description
Change in scores on Questionnaire measuring self-efficacy at 12 month assessment from baseline score
Time Frame
12 months
Title
Change in Reintegration to Normal Living Index
Description
Change score on Questionnaire measuring participation at 12 month assessment from baseline score
Time Frame
12 months
Title
Change in Satisfaction with Life Scale
Description
Change in score on Questionnaire measuring satisfaction with life at 12 month assessment from baseline score
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Mulroy, PhD, PT
Phone
562-385-7177
Email
smulroy@dhs.lacounty.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Mulroy, PhD, PT
Organizational Affiliation
Rancho Los Amigos National Rehab Ce
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rancho Los Amigos National Rehabilitaiton Center
City
Downey
State/Province
California
ZIP/Postal Code
90242
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Mulroy, PT, DPT
Phone
562-385-7177
Email
smulroy@dhs.lacounty.gov
First Name & Middle Initial & Last Name & Degree
Sara J Mulroy, PhD, PT

12. IPD Sharing Statement

Plan to Share IPD
No

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Interactive Telehealth for Wheelchair Users

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