| 基本情報/Basic information |
| 一般向け試験名/Public title |
視覚遅延フィードバックが片麻痺症例の座位バランス制御に与える影響 |
Efficacy of Sitting Balance Training with Delayed Visual Feedback among Stroke Patients: A Randomized Crossover Clinical Trial |
| 一般向け試験名略称/Acronym |
視覚遅延フィードバックの座位バランス制御に与える影響 |
Efficacy of Sitting Balance Training with Delayed Visual Feedback |
| 科学的試験名/Scientific Title |
視覚遅延フィードバックが片麻痺症例の座位バランス制御に与える影響 |
Efficacy of Sitting Balance Training with Delayed Visual Feedback among Stroke Patients: A Randomized Crossover Clinical Trial |
| 科学的試験名略称/Scientific Title:Acronym |
視覚遅延フィードバックが片麻痺症例の座位バランス制御に与える影響 |
Efficacy of Sitting Balance Training with Delayed Visual Feedback among Stroke Patients: A Randomized Crossover Clinical Trial |
| 試験実施地域/Region |
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| 介入/Intervention |
| 群数/No. of arms |
2 |
| 介入の目的/Purpose of intervention |
治療・ケア/Treatment |
| 介入の種類/Type of intervention |
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| 介入1/Interventions/Control_1 |
視覚遅延フィードバック条件にて、5日間実施する。
60回、500ms遅延した条件にて実施する。 |
The starting position was sitting position in Control Condition (CC) and DVF Condition (DVFC). Participants did balance training with real-time VF in CC. The DVFC was used to feedback the projected CoP on the monitor with a 500ms delay.
The task was to perform a maximal lateral tilt to shift the CoG to the paretic side. The self-CoP projected on the monitor was used for DVF. In addition, the participants were not permitted to lift on their ischium of the non-paretic side. The verbal instructions for both tasks were: "After the signal, check the CoG on the monitor and move your CoG to the paretic side (left or right) to the maximum extent possible". |
| 介入2/Interventions/Control_2 |
視覚遅延フィードバックなし条件にて、5日間実施する。
60回、500ms遅延した条件にて実施する。 |
The starting position was sitting position in Control Condition (CC) and DVF Condition (DVFC). Participants did balance training with real-time VF in CC. The DVFC was used to feedback the projected CoP on the monitor with a 500ms delay.
The task was to perform a maximal lateral tilt to shift the CoG to the paretic side. The self-CoP projected on the monitor was used for DVF. In addition, the participants were not permitted to lift on their ischium of the non-paretic side. The verbal instructions for both tasks were: "After the signal, check the CoG on the monitor and move your CoG to the paretic side (left or right) to the maximum extent possible". |
| 介入3/Interventions/Control_3 |
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| 介入4/Interventions/Control_4 |
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| 介入5/Interventions/Control_5 |
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| 介入6/Interventions/Control_6 |
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| 介入7/Interventions/Control_7 |
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| 介入8/Interventions/Control_8 |
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| 介入9/Interventions/Control_9 |
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| 介入10/Interventions/Control_10 |
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| 適格性/Eligibility |
| 年齢（下限）/Age-lower limit |
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| 年齢（上限）/Age-upper limit |
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| 性別/Gender |
男女両方/Male and Female |
| 選択基準/Key inclusion criteria |
組み入れ基準は、言葉による説明で調査対象を理解できること、2分間座位保持可能であること、亜急性期から慢性期の間にComputing Tomography（CT）とMagnetic Resonance Imaging（MRI）による片側の病変があることとしました。 |
The inclusion criteria were the ability to understand the issue being investigated through verbal explanations, the ability to sit in 2 min, and the presence of a unilateral lesion by Computing Tomography (CT) and Magnetic Resonance Imaging (MRI) between subacute phase and chronic phase. |
| 除外基準/Key exclusion criteria |
除外基準として、整形外科手術歴、脳幹病変、小脳病変、多発性脳梗塞、くも膜下出血、水頭症、片側空間無視、視線追跡障害、重度の高次脳機能障害などとした。 |
Exclusion criteria included a history of orthopedic surgery, brainstem lesions, cerebellar lesions, multiple cerebral infarctions, subarachnoid hemorrhage, hydrocephalus, unilateral spatial neglect, disability of eyes tracking, and severe higher brain dysfunction. |
| 目標参加者数/Target sample size |
26 |
| 結果/Result |
| 結果掲載URL/URL related to results and publications |
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| 組み入れ参加者数/Number of participants that the trial has enrolled |
26 |
| 主な結果/Results |
CoP
、側方距離（LD）は、500ms遅延フィードバック介入後が81.0±86.8mmとなった。遅延条件と時間には単純な主効果が認められ、時間と遅延条件の間には交互作用が認められた。
FIST
FISTスコアは、DVFCの介入前は49.9±5.9点、DVFCの500ms後は52.6±3.7点、CCの0ms後は52.9±4.7点であった。
FIM
FIMスコアは、介入前が64.0±21.0点、CC後が64.0±20.0点、DVFC後が69.0±23.0点という結果であった。 |
As a result of lateral distance were 62.0 mm after 0 ms feedback intervention and 81.0 mm after 500 ms delayed feedback intervention.
FIST score resulted DVFC, the score was 49.9 points, 52.6 points after 500ms in DVFC and 52.9 points after 0 ms in CC.
FIM score resulted in 69.0 points after DVFC. In DVFC, the following results were obtained 69.8 points before intervention, 79.3 points after DVFC. |
| 主な結果入力日/Results date posted |
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| 結果掲載遅延/Results Delayed |
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| 結果遅延理由/Results Delay Reason |
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| 最初の試験結果の出版日/Date of the first journal publication of results |
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| 参加者背景/Baseline Characteristics |
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| 参加者の流れ/Participant flow |
無作為化は、実験参加者と対照参加者が同数になるようにブロックされた乱数表を用いて、研究から独立した人物が事前に作成した割付を封入した不透明な封筒を使用することで、募集担当者と評価者から隠蔽した。評価者は割り付けには盲目で、トレーニング後に結果指標を収集した。いくつかの結果指標の収集には、盲検化された2人の人物が必要であった。バイアスを減らすために、盲検化された2人の評価者がすべての指示と結果の測定を行った。計算された乱数により、研究参加者を対照群と実験群に分類した。症例の選択と割り付けについては、Consort（Consolidated Standards of Reporting Trials）の手順を従った。 |
Randomization was concealed from the recruiter and assessor by using sealed opaque envelopes containing the allocation, which was generated earlier by a person independent of the study using random number tables, blocked to ensure equal numbers of experimental and control participants. The assessor was blinded to allocation and collected the outcomes measures post training. The collection of some outcome measures required two persons, whom was blinded. To reduce bias, the blinded two assessors gave all instructions and measured outcomes. Computed random numbers categorized the study participants into control and experimental groups. We followed the procedure for selection and allocation of cases by Consolidated Standards of Reporting Trials (CONSORT).
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| 有害事象/Adverse events |
なし |
None |
| 評価項目/Outcome measures |
理学療法評価として、CoP、FIST、FIM（Functional Independence Measure）を測定した。 |
We measured CoP, FIST, and Functional Independence Measure (FIM) as physiotherapy assessments. |
| 個別症例データ共有計画/Plan to share IPD |
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| 個別症例データ共有計画の詳細/IPD sharing Plan description |
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UMIN-CTR 臨床試験登録情報の閲覧