Exercise to Improve Balance in Older Adults With Hearing Impairment - a Proof-of-concept Study
Balance and Mobility in Older Adults With Hearing Impairment
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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)
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:他の
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:Virtual reality exercise
20 participants will be randomised to this arm
|
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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実験的:Vestibular rehabilitation exercise
20 participants will be randomised to this arm
|
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.
|
他の:Control
20 participants will be randomised to this arm
|
Participants will not be randomised to either of the exercise interventions, but will be adviced to stay active
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Short physical performance battery
時間枠: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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Standing balance - posturography
時間枠: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
|
Walking balance
時間枠: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
|
Participants will walk across an electronic walkway that registers steps, for analysis of gait steadiness
|
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)
時間枠: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
|
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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Activity monitoring
時間枠:Measured as change from baseline/before intervention to after intervention (6 weeks after baseline)
|
Participants will wear sensors over 4 days, registering activity in their own environments
|
Measured as change from baseline/before intervention to after intervention (6 weeks after baseline)
|
Dizziness Handicap Inventory
時間枠:Measured at baseline/before intervention and after intervention (6 weeks after baseline)
|
25 item-questionnaire that registers limitations due to dizziness.
Possible scores range from 0-100, and higher scores indicate more dizziness-related handicap.
|
Measured at baseline/before intervention and after intervention (6 weeks after baseline)
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Virtual reality exerciseの臨床試験
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Hospital Universitari Vall d'Hebron Research InstituteUniversitat Autonoma de Barcelona募集
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University of Erlangen-Nürnberg Medical SchoolKlinikum Nürnberg完了
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University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); University... と他の協力者招待による登録
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Shanghai Jiao Tong University School of Medicine積極的、募集していない
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University of TorontoUniversity Health Network, Toronto; University of Western Ontario, Canada; Institute for Clinical... と他の協力者完了
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University of WashingtonNational Institute on Aging (NIA); Kaiser Permanente完了
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Hospital Universitari Vall d'Hebron Research Institute積極的、募集していない