People With Osteoporosis Can Walk-BEST to Reduce Fall and Fracture Risk (Walk-BEST)
調査の概要
状態
条件
詳細な説明
The Walk-BEST™ technology assisted gait optimization program has demonstrated effectiveness in improving gait pattern and walking capacity without adverse events in people living with Parkinson's and Multiple Sclerosis. What is not known and the topic of this pilot and feasibility study is whether older people with osteoporosis will engage successfully with this program, since they do not have a diagnosis of a disabling condition affecting gait and may be unaware that their cautious method of walking exposes them to higher risk of falls and fractures rather than protecting them.
A randomized pilot and feasibility study (PAFS) will be conducted with groups randomized in a 1:1 ratio. Participants will be randomly assigned to either 1) immediate receipt of the Walk-BEST™ program; or 2) wait-list control and delayed receipt of Walk-BEST™ program 3 months post-randomization.
Participants will receive a copy of a proprietary workbook with instructions on simple exercises targeting strength, flexibility, and balance to facilitate a better walking pattern, as well as both 3-5 remote sessions with an exercise professional to practice walking well and to learn how to use the Heel2ToeTM sensor, and two technology phone calls with a research team member, over the first 4 weeks of the intervention. This personal gait training period will be followed by independent home practice over 2 months, during which participants will be instructed to practice walking with the sensor for a minimum period of 6 min, twice a day and to complete three exercises from their workbook at least twice a week.
There will be three on-site study visits at 3-month intervals: one for initial assessment, and two for reassessment.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Velizara Garkova, MSc
- 電話番号：47071 514-934-1934
- メール：velizara.garkova@rimuhc.ca
研究場所
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Quebec
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Montreal、Quebec、カナダ、H4A 3S5
- 募集
- Research Institute of the McGill University Health Centre
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コンタクト：
- 電話番号：5149341934
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主任研究者：
- Suzanne Morin, MD
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参加基準
適格基準
就学可能な年齢
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- men and women 70 years and older
- able to walk independently with or without a walking aid
- experienced a prior fracture after the age of 40, OR two falls in the past 12 months, OR who have a bone mineral density test (done as part of routine clinical evaluation) with a T-score < -2.5, OR on a Health Canada-approved anti-osteoporosis medication (oral or intravenous bisphosphonate, denosumab, teriparatide, or romozosumab) to reduce fracture risk or on a bisphosphonate drug holiday (planned treatment interruption)
Exclusion Criteria:
- fracture sustained in the past 12 months
- unable to walk unsupervised because of active medical or neurocognitive reasons
- unable to provide informed consent, or cannot communicate in English or French
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：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- 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 |
|---|---|
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実験的：Walk-BEST Immediate
Assigned to receive the Heel2Toe sensor and Walk BEST intervention right away.
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Heel2Toe is a new generation of wearables that provides real-time auditory feedback when the person takes a good step, one in which the step is initiated with a strong heel strike.
Co-designed, evidence-based technology-assisted, therapeutic walking program developed by physiotherapy researchers, clinicians, and frail and non-frail seniors.
It consists of training elements (derived through international consensus and endorsed by 600 older Canadians) for optimal gait pattern with the use of a biofeedback device, the Heel2Toe™ sensor, which is introduced to reinforce the gait optimizing training and encourage home practice.
他の名前：
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アクティブコンパレータ：Walk-BEST Delayed
Assigned to receive the Heel2Toe sensor and Walk BEST intervention after a delay of 3 months.
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Heel2Toe is a new generation of wearables that provides real-time auditory feedback when the person takes a good step, one in which the step is initiated with a strong heel strike.
Co-designed, evidence-based technology-assisted, therapeutic walking program developed by physiotherapy researchers, clinicians, and frail and non-frail seniors.
It consists of training elements (derived through international consensus and endorsed by 600 older Canadians) for optimal gait pattern with the use of a biofeedback device, the Heel2Toe™ sensor, which is introduced to reinforce the gait optimizing training and encourage home practice.
他の名前：
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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 |
|---|---|---|
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Study recruitment rates (feasibility objective)
時間枠：3 months
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The study will be considered feasible if the investigator can recruit 28 participants
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3 months
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Study retention rates (feasibility objective)
時間枠：9 months
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The study will be considered feasible if ≥ 75 % of the sample completes the final assessment
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9 months
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Adherence to intervention (feasibility objective)
時間枠：9 months
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The intervention will be considered feasible if participants complete ≥ 65% of the prescribed number of walking sessions at the 6-month follow-up.
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9 months
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Perceived acceptability and usability of the Heel2Toe sensor (feasibility objective)
時間枠：9 months
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The acceptability outcomes will be based on an exit debriefing questionnaire.
Usability of the Heel2Toe sensor will be quantified with items from the Digital Health Devices Usability Indicators.
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9 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Functional walking capacity
時間枠：Change from Baseline to 3 months, 6 months
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Six Minute Walk Test (6MWT)
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Change from Baseline to 3 months, 6 months
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Grip strength
時間枠：Change from Baseline to 3 months, 6 months
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Hand Dynamometer
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Change from Baseline to 3 months, 6 months
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Balance
時間枠：Change from Baseline to 3 months, 6 months
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Mini-Best Test (0-28; higher is better)
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Change from Baseline to 3 months, 6 months
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Functional leg muscle strength
時間枠：Change from Baseline to 3 months, 6 months
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30-second Chair stand test
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Change from Baseline to 3 months, 6 months
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Fear of falling
時間枠：Change from Baseline to 3 months, 6 months
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6-Item Revised Fear of Falling Questionnaire (6-24, lower is better)
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Change from Baseline to 3 months, 6 months
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Physical activity
時間枠：Change from Baseline to 3 months, 6 months
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Physical Activity Scale for the elderly (0-400+; higher is better)
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Change from Baseline to 3 months, 6 months
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Lower limb function
時間枠：Change from Baseline to 3 months, 6 months
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Lower Extremity Functional Scale (0-80; higher is better)
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Change from Baseline to 3 months, 6 months
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Quality of Life
時間枠：Change from Baseline to 3 months, 6 months
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Older Persons Active Living Related Quality of Life (8-32, higher is better)
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Change from Baseline to 3 months, 6 months
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Falls
時間枠：Change from Baseline to 3 months, 6 months
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Number of falls reported in the falls calendar
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Change from Baseline to 3 months, 6 months
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Angular velocity of ankle during three phases of gait cycle, heel-strike, push-off, swing averaged over a walk of at least 50 steps
時間枠：Change from Baseline to 3 months, 6 months
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Degrees per second
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Change from Baseline to 3 months, 6 months
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Co-efficient of variation of angular velocity of ankle during three phases of gait cycle, heel-strike, push-off, swing averaged over a walk of at least 50 steps
時間枠：Change from Baseline to 3 months, 6 months
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Degrees per second
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Change from Baseline to 3 months, 6 months
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協力者と研究者
捜査官
- 主任研究者：Suzanne Morin, MD、RI-MUHC
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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。