Exercise to Improve Balance in Older Adults With Hearing Impairment - a Proof-of-concept Study
2020년 2월 24일 업데이트: Bård Bogen, Western Norway University of Applied Sciences
Balance and Mobility in Older Adults With Hearing Impairment
Hearing impairment is common in older adults, and recent research points to associations between hearing impairment and balance/mobility.
The association may be due to more attentional resources being used to compensate for the sensory loss, with less resources available for maintaining balance.
The aim of this projects is therefore to investigate whether an exercise program with focus on motor-cognitive tasks is feasible for older adults with hearing impairment.
The study is meant as a proof-of-concept study, where trialling will be evaluated, and results will be used to inform the design of a larger and adequately powered study.
연구 개요
상태
알려지지 않은
상세 설명
Study design:
This is an experimental (exercise) study with follow-ups three and twelve months after exercise completion.
Participants:
Participants will be recruited from two instances:
- "Praksisnett", which is a collaboration between GPs and researchers in Bergen, Norway, where GPs recruit potential participants to research projects.
- The Ear, Nose, Throat department at Haukeland University Hospital (Bergen), who provide service to older adults with hearing impairment. The aim is to include 60 patients into three intervention arms: i) virtual reality exercises, ii) vestibular rehabilitation exercises and usual care
Intervention arms:
- Virtual reality exercises: Participants will exercise in virtual environments twice weekly. The choice of environments/tasks will be individualized, and progress from sitting/standing exercises, to doing exercises while walking on a treadmill. The aim is to perform cognitive and motor tasks simultanously.
- Vestibular rehabilitation exercises: This is an exercise approach that has been used in clinical groups, such as patients with vestibular disorders and traumatic brain injury. The aim is to perform movements/exercises where the participant is exposed gradually to movements that may be provocative for the vestibular system.
The exercises will be done in a movement lab at Western Norway University of Applied Sciences. Participants will be randomised to either of the three intervention arms using a computerized procedure. Neither participants, testers or deliverers of the intervention will be blinded. Testers and intervention deliverers will be physiotherapists, students enrolled in a master program in clinical physiotherapy and bachelor students in physiotherapy.
연구 유형
중재적
등록 (예상)
60
단계
- 해당 없음
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
70년 이상 (고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Hearing threshold above 30 dB
Exclusion Criteria:
- Inability to give informed consent,
- Inability to speak Scandinavian languages or English
- Diseases with severe motor impairments (such as mb Parkinsons)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Virtual reality exercise
20 participants will be randomised to this arm
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Participants will do exercises in a virtual environment, solving tasks that require cognitive efforts and motor/balance efforts.
The virtual environment/tasks will be delivered through a head-mounted display ("goggles").
Difficulty will progress from standing/sitting, to walking on a treadmill.
The environments that will be used will be both over-the-counter environments, as well as in-house designed environments.
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실험적: Vestibular rehabilitation exercise
20 participants will be randomised to this arm
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Vestibular rehabilitation exercises focus on head and eyes movements, as well as whole-body movements.
The aim is to facilitate the use of other sensory organs than the vestibular organs, which will also be relevant to persons who are not receiving sufficient sensory information from the auditory system.
The exercises will progress as tolerated, under careful supervision of trained therapists.
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다른: Control
20 participants will be randomised to this arm
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Participants will not be randomised to either of the exercise interventions, but will be adviced to stay active
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Short physical performance battery
기간: Measured as change from baseline/before intervention, to after intervention (six weeks after baseline), to three months after intervention and to 12 months after intervention
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Test of balance and mobility, with three tasks (walking, standing balance, sit-to-stand), scores from 0-12.
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Measured as change from baseline/before intervention, to after intervention (six weeks after baseline), to three months after intervention and to 12 months after intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Standing balance - posturography
기간: Measured as change from baseline/before intervention, to after intervention (six weeks after baseline), to three months after intervention and to 12 months after intervention
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Body sway measured on a balance platform, with eyes open/closed and on a firm/compliant surface
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Measured as change from baseline/before intervention, to after intervention (six weeks after baseline), to three months after intervention and to 12 months after intervention
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Walking balance
기간: Measured as change from baseline/before intervention, to after intervention (six weeks after baseline), to three months after intervention and to 12 months after intervention
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Participants will walk across an electronic walkway that registers steps, for analysis of gait steadiness
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Measured as change from baseline/before intervention, to after intervention (six weeks after baseline), to three months after intervention and to 12 months after intervention
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The World Health Organisation Disability Assessment Schedule (WHODAS)
기간: Measured as change from baseline/before intervention, to after intervention (six weeks after baseline), to three months after intervention and to 12 months after intervention
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Questionnaire that registers disability across several domains.
Possible score range is 0-144, where lower values indicate less disability
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Measured as change from baseline/before intervention, to after intervention (six weeks after baseline), to three months after intervention and to 12 months after intervention
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Activity monitoring
기간: Measured as change from baseline/before intervention to after intervention (6 weeks after baseline)
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Participants will wear sensors over 4 days, registering activity in their own environments
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Measured as change from baseline/before intervention to after intervention (6 weeks after baseline)
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Dizziness Handicap Inventory
기간: Measured at baseline/before intervention and after intervention (6 weeks after baseline)
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25 item-questionnaire that registers limitations due to dizziness.
Possible scores range from 0-100, and higher scores indicate more dizziness-related handicap.
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Measured at baseline/before intervention and after intervention (6 weeks after baseline)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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 5월 1일
기본 완료 (예상)
2021년 12월 31일
연구 완료 (예상)
2022년 9월 1일
연구 등록 날짜
최초 제출
2019년 12월 22일
QC 기준을 충족하는 최초 제출
2020년 2월 24일
처음 게시됨 (실제)
2020년 2월 25일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 2월 25일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 2월 24일
마지막으로 확인됨
2020년 2월 1일
추가 정보
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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