Targeting Balance Confidence to Increase Community Integration in Users of Prostheses
2022年5月31日 更新者：Noah Rosenblatt、Rosalind Franklin University of Medicine and Science
Targeting Balance Confidence as a Strategy to Increase Integration and Improve Outcomes in Users of Lower-Limb Prostheses
Low balance confidence occurs when an individual perceives they have limited ability to maintain their balance while performing a specific task of daily living.
It is a prevalent problem in lower limb prosthesis users and is a strong predictor of prosthesis use and community participation.
Balance confidence is not necessarily related to functional abilities.
It is possible to improve functional ability as a result of rehabilitation, without concurrently improving balance confidence.
Interventions to address low balance confidence may need to target both functional abilities as well as beliefs regarding these abilities.
The purpose of this study is to test whether, for users of lower limb prostheses, an intervention combining physical therapy exercise to improve function with cognitive behavioral therapy to address fears and thoughts associated with low confidence can improve balance confidence and promote community participation.
調査の概要
状態
完了
詳細な説明
Lower limb prosthesis users, with self-reported low balance confidence complete baseline gait analysis and balance testing, as well as a series of validated self-reported outcome scales addressing balance confidence, quality of life, and community integration.
Participants are then provided a step activity monitor (SAM) and a global position sensing (GPS) tracker to be worn for one week, the data from which is linked and used to objectively quantify baseline community participation.
At the conclusion of the one week, participants are randomized to one of two groups, each of which will last for 8 weeks.
At the conclusion of the eight weeks, participants repeat baseline assessments and are again provided a SAM and GPS tracker to wear for one week.
Baseline measures and activity monitoring occur again 8 and 16 weeks thereafter.
研究の種類
介入
入学 (実際)
22
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Illinois
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North Chicago、Illinois、アメリカ、60064
- Captain James A. Lovell Federal Health Care Center
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North Chicago、Illinois、アメリカ、60064
- Rosalind Franklin University of Medicine and Science
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- age ≥18 years
- unilateral lower limb amputation without serious complications
- at least 6 months experience using a definitive lower limb prosthesis
- Activity Specific Balance Confidence (ABC) scale score≤80
- self-reported concern about balance that limit activities
Exclusion Criteria:
- active wounds on weight bearing surfaces
- inability to perform the protocol without an assistive device
- currently seeing a physical therapist for any reason
- history of neurodegenerative disease
- history of stroke
- ill-fitting or ill-functioning prosthesis (to be verified by research prosthetist during screening)
- prohibited by primary care physician or research physician to participate in mild exercise
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：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 |
|---|---|
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実験的：Exercise Group A
Weekly exercise sessions with physical therapist and psychologist
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Eight weekly sessions integrating techniques from physical therapy and cognitive behavioral therapy.
At the start of each session participants play virtual reality games that target balance and functional gait and then discuss their balance confidence and activity avoidance behaviors with a behavioural counselor.
Weekly homework assignments ask participants to report on thoughts causing them to avoid activities and to slowly engage in activities that present increasing levels of fear.
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プラセボコンパレーター：Exercise Group B
Home-based exercises
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Stretching and other exercises are safely taught by physical therapist and then practiced at home following a provided schedule.
Participants receive periodic calls to discuss progress.
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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 |
|---|---|---|
|
Community integration
時間枠：24 weeks
|
number of steps taken outside of the home
|
24 weeks
|
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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Social Functioning scale from the 36-item Short Form Health Survey
時間枠：24 weeks
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The scale measures the extent to which physical and emotional problems interfere with social activities on a scale of 0-100 with higher scores indicating less interference
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24 weeks
|
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Role Limitation due to Emotional Problems scale from the Short Form Health Survey (SF36)
時間枠：24 weeks
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The scale measures the extent to which emotional problems interfere with work and daily activities on a scale of 0-100 with higher scores indicating less interference
|
24 weeks
|
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Extent of Participation scale from the Measure of Community Reintegration of Servicemembers
時間枠：24 weeks
|
The scale measures community participation in terms of how often an individual engages in certain activities on a score of 10-70 with higher scores indicating greater participation
|
24 weeks
|
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Perceived Limitation scale from the Measure of Community Reintegration of Servicemembers
時間枠：24 weeks
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The scale measures self-perceived limitations in community participation n a score of 10-70 with higher scores indicating less limitation
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24 weeks
|
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Frenchay Activity Index
時間枠：24 weeks
|
This is a behavioral scale that primarily measures social participation, as well as daily activities on a score of 0-45 with higher scores indicating greater social activity.
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24 weeks
|
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Change from baseline in Activity-specific balance confidence scale following the intervention
時間枠：8 weeks
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The ABC scale measures balance confidence on a scale of 0-100 with higher values indicating greater confidence
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8 weeks
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Activity-specific balance confidence scale
時間枠：24 weeks
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The ABC scale measures balance confidence on a scale of 0-100 with higher values indicating greater confidence.
Measurement at this time point will indicate the lasting impact of the intervention on balance confidence
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24 weeks
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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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Well-being scale from the Prosthetic Evaluation Questionnaire
時間枠：24 weeks
|
The scale measures overall quality of life on a score of 0-100 with higher scores indicating increased quality of life.
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24 weeks
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Change from baseline in Berg Balance Scale
時間枠：8 wks
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This scale measures measures balance function by assessing the performance of functional tasks.
It is scored from 0-45 with high scores indicating better balance.
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8 wks
|
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Change from baseline on L-test performance
時間枠：8 wks
|
Participants rise from a chair without armrests, walk 3m, turn right, walk 7m, turn around and trace their path back to the start.
Time to complete the task is noted.
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8 wks
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年4月5日
一次修了 (実際)
2022年5月1日
研究の完了 (実際)
2022年5月1日
試験登録日
最初に提出
2018年1月10日
QC基準を満たした最初の提出物
2018年1月18日
最初の投稿 (実際)
2018年1月26日
学習記録の更新
投稿された最後の更新 (実際)
2022年6月1日
QC基準を満たした最後の更新が送信されました
2022年5月31日
最終確認日
2022年5月1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。