Visual Dependence and Multisensory Balance Rehabilitation After Stroke
2021年2月10日 更新者：Shu-Chun Lee、Taipei Medical University
Post-Stroke Visual Dependence and Early Intervention of Multisensory Balance Rehabilitation
This cross-sectional study aims to investigate the prevalence of post-stroke visual dependence, and the effects of visual dependence on balance and gait.
It also determines whether visual dependence could differentiate stroke patients with a history of falls from without.
調査の概要
詳細な説明
Stroke participants will be recruited to measure the level of visual dependence, muscle strength, neurological recovery, balance ability, vertigo symptom, gait pattern and activities of daily living.
This will calculate the prevalence of post-stroke visual dependence, and investigate the negative impact of visual dependence on balance and walking functions.
This also determines whether the value of visual dependence could differentiate stroke patients with a history of falls from without a history of falls.
研究の種類
観察的
入学 (実際)
100
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
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Taipei、台湾、110
- Taipei Medical University
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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
20年～80年 (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
サンプリング方法
非確率サンプル
調査対象母集団
Chronic stroke patients with the first stroke will be recruited from the 3 departments of physical and rehabilitation medicine, regional hospitals.
説明
Inclusion Criteria:
- 1) first stroke with 20-80 years of age
- 2) the time since onset is more than 6 months
- 3) can walk independently at least 10 meters without any walking devices and orthosis
- 4) normal cognitive function with scoring more than 24 on the Mini Mental State Examination scale
- 5) can understand and follow commands
- 6) can give informed consent
Exclusion Criteria:
- 1) other neurological disorders which could affect balance assessment
- 2) cerebellar stroke
- 3) diagnosis with central or peripheral vestibular diseases.
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
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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Perceived visual dependence
時間枠：Baseline
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Perceived visual dependence will be assessed using a computerized Rod and Disc Test (RDT).
Participants will adjust a tilted rod to their subjective visual vertical with rotating visual background.
The error (degrees) between subjective visual vertical and gravitational vertical will be measured and represented as the level of visual dependence.
Higher error indicates higher level of perceived visual dependence.
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Baseline
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Postural visual dependence
時間枠：Baseline
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Postural sway will be measured using an accelerometer attached on the lower back when participants are looking at blank wall, eyes closed and looking at rotating visual background.
Greater postural sway in conditions with eyes closed and rotating visual background corresponding to looking at blank wall represents the higher level of postural visual dependence.
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Baseline
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A history of falls
時間枠：Baseline
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Any falls in the past year (n).
Fall is defined by the inadvertently coming to rest on the ground, floor or other lower level, excluding intentional change in position to rest in furniture, wall or other objects.
More than once fall is identified as faller.
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Baseline
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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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Physical impairment of paretic leg and foot
時間枠：Baseline
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Physical impairment of paretic leg and foot will be assessed by the Chedoke-McMaster Stroke Assessment (CMSA) with scoring on a 7-point scale (Stage 1 through 7, most impairment through to no impairment, respectively).
The higher stage indicates the better neurological recovery.
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Baseline
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Five Times Sit to Stand Test
時間枠：Baseline
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The five Times Sit to Stand Test (5STS) evaluates functional lower extremity strength.
Participants will be asked to sit to stand for 5 times as quickly as possible.
The time to complete the task will be recorded.
The shorter duration (s) represents the better muscle strength in lower limbs.
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Baseline
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Berg Balance Scale
時間枠：Baseline
|
The Berg balance scale (BBS) is used to objectively determine a participant's ability to safely balance during a series of predetermined tasks.
It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.
The total score is 56.
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Baseline
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Timed Up and Go test
時間枠：Baseline
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The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance.
It uses the time that a person takes to rise from a chair, walk 3 meters, turn around, walk back to the chair, and sit down.
The longer duration (s) to complete the task represents the poorer balance.
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Baseline
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Modified Clinical Test of Sensory Integration and Balance
時間枠：Baseline
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Modified Clinical Test of Sensory Integration and Balance (mCTSIB) is designed to assess how well an older adult is using sensory inputs when one or more sensory systems are compromised.
Postural sway will be measured using an accelerometer attached on the lower back in 4 sensory conditions with visual and proprioceptive manipulation.
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Baseline
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Falls Efficacy Scale - International
時間枠：Baseline
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Falls Efficacy Scale- International (FES-I) assesses subjects' concerns about falling.
It consists of 16 questions related to everyday activities and subjects are asked to rate whether they were "not at all" (a score of 1), "somewhat" (2), "fairly" (3) or "very" (4) concerned about falling when doing that particular activity.
The sum scores ranged 16 - 64 with higher scores indicating a greater fear of falling.
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Baseline
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Situational Vertigo Questionnaire
時間枠：Baseline
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The Situational Vertigo Questionnaire (SVQ) is a 19-item questionnaire specifically aimed at identifying the presence of visual vertigo, a condition attributable to a defective vestibular compensation strategy, which is too dependent on the available visual information.
Higher score represents more severe vertigo symptoms.
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Baseline
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Gait pattern
時間枠：Baseline
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Gait pattern will be evaluated using a Opal wireless system.
Participants will be asked to walk in a 14-meter walkway.
The first and final 2 meters are designed for acceleration and deceleration.
The middle 10-meter will be analyzed only.
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Baseline
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Barthel index
時間枠：Baseline
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The Barthel Index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL).
Ten variables describing ADL and mobility are scored.
The total score is 100 and higher score represents more independent in ADL.
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Baseline
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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。
捜査官
- 主任研究者：Shu-Chun Lee、Taipei Medical University
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)
2020年2月1日
一次修了 (実際)
2021年1月14日
研究の完了 (実際)
2021年1月14日
試験登録日
最初に提出
2020年12月8日
QC基準を満たした最初の提出物
2021年1月7日
最初の投稿 (実際)
2021年1月11日
学習記録の更新
投稿された最後の更新 (実際)
2021年2月11日
QC基準を満たした最後の更新が送信されました
2021年2月10日
最終確認日
2021年2月1日
詳しくは
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