Interactive Telehealth for Wheelchair Users

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

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.

Study Overview

• Status: Unknown
• Conditions: Spinal Cord Injuries; Paraplegia; Pressure Ulcer, Buttock
• Intervention / Treatment: Device: An interactive telehealth monitoring and biofeedback system; Behavioral: Education Control

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
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara Mulroy, PhD, PT; Phone Number: 562-385-7177; Email: smulroy@dhs.lacounty.gov

Study Locations

• United States
  • California
    • Downey, California, United States, 90242
      • Rancho Los Amigos National Rehabilitaiton Center
      • Contact: Sara Mulroy, PT, DPT; Phone Number: 562-385-7177; Email: smulroy@dhs.lacounty.gov
      • Principal Investigator: Sara J Mulroy, PhD, PT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of Pressure Ulcer	Any stage of Pressure Ulcer/Injury identified in the ischial region	Any time during the one year active phase of the study intervention
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	The four weeks preceding the 12 month assessments
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	The four weeks preceding the 12 month assessments
Time to Recurrence of Pressure Ulcer	The number of days from study entry to identification of recurrence of Pressure Ulcer/Injury	Any time during the one year active phase of the study intervention

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rancho Research Institute, Inc.
• Collaborators: National Institute on Aging (NIA); BioSensics
• Investigators: Principal Investigator: Sara Mulroy, PhD, PT, Rancho Los Amigos National Rehab Ce

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2020
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: February 7, 2020
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (Actual): February 12, 2020

Study Record Updates

• Last Update Posted (Actual): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Spinal cord injury; Pressure Ulcer
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Skin Diseases; Neurologic Manifestations; Wounds and Injuries; Skin Ulcer; Trauma, Nervous System; Spinal Cord Diseases; Paralysis; Spinal Cord Injuries; Pressure Ulcer; Paraplegia
• Other Study ID Numbers: 5R44AG059275-04 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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