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Interactive Telehealth for Wheelchair Users

2020년 2월 10일 업데이트: Sara Mulroy, Rancho Research Institute, Inc.

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.

연구 개요

상태

알려지지 않은

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (예상)

50

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • California
      • Downey, California, 미국, 90242
        • Rancho Los Amigos National Rehabilitaiton Center

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
장치: 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.
가짜 비교기: 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.
행동: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Recurrence of Pressure Ulcer
기간: Any time during the one year active phase of the study intervention
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
기간: 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
The four weeks preceding the 12 month assessments
Change in mean number of pressure relief maneuvers per day from Baseline
기간: 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
The four weeks preceding the 12 month assessments
Time to Recurrence of Pressure Ulcer
기간: 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
Any time during the one year active phase of the study intervention

2차 결과 측정

결과 측정
측정값 설명
기간
Change in Patient Health Questionnaire-9 score
기간: 12 months
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
기간: 12 months
Change in scores on Questionnaire measuring self-efficacy at 12 month assessment from baseline score
12 months
Change in Reintegration to Normal Living Index
기간: 12 months
Change score on Questionnaire measuring participation at 12 month assessment from baseline score
12 months
Change in Satisfaction with Life Scale
기간: 12 months
Change in score on Questionnaire measuring satisfaction with life at 12 month assessment from baseline score
12 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Rancho Research Institute, Inc.

협력자

National Institute on Aging (NIA)
BioSensics

수사관

  • 수석 연구원: Sara Mulroy, PhD, PT, Rancho Los Amigos National Rehab Ce

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (예상)

2020년 3월 1일

기본 완료 (예상)

2021년 4월 1일

연구 완료 (예상)

2022년 1월 1일

연구 등록 날짜

최초 제출

2020년 2월 7일

QC 기준을 충족하는 최초 제출

2020년 2월 10일

처음 게시됨 (실제)

2020년 2월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 2월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2020년 2월 10일

마지막으로 확인됨

2020년 2월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 5R44AG059275-04 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

예

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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