コクランライブラリー：脳卒中後の活動制限と機能障害に対するリハビリテーションに費やした時間の影響

https://doi.org/10.1002/14651858.CD012612.pub2

Background

Stroke affects millions of people every year and is a leading cause of disability, resulting in significant financial cost and reduction in quality of life. Rehabilitation after stroke aims to reduce disability by facilitating recovery of impairment, activity, or participation. One aspect of stroke rehabilitation that may affect outcomes is the amount of time spent in rehabilitation, including minutes provided, frequency (i.e. days per week of rehabilitation), and duration (i.e. time period over which rehabilitation is provided). Effect of time spent in rehabilitation after stroke has been explored extensively in the literature, but findings are inconsistent. Previous systematic reviews with meta‐analyses have included studies that differ not only in the amount provided, but also type of rehabilitation.
Background
背景
脳卒中は毎年何百万人もの人々に影響を及ぼし、障害の主要な原因となっています。これは、経済的コストの増加と生活の質の低下をもたらしています。脳卒中後のリハビリは、障害の回復を促進することによって障害を軽減することを目的としています。脳卒中リハビリの一つの側面であるリハビリに費やす時間は、結果に影響を与える可能性があります。しかし、その効果についての研究結果は一貫していません。以前の系統的レビューとメタアナリシスには、提供される時間だけでなく、リハビリの種類が異なる研究が含まれていました。

Objectives

To assess the effect of 1. more time spent in the same type of rehabilitation on activity measures in people with stroke; 2. difference in total rehabilitation time (in minutes) on recovery of activity in people with stroke; and 3. rehabilitation schedule on activity in terms of: a. average time (minutes) per week undergoing rehabilitation, b. frequency (number of sessions per week) of rehabilitation, and c. total duration of rehabilitation.
Objectives
目的

1. 脳卒中患者における同じタイプのリハビリに費やされる時間の増加が活動の測定に及ぼす影響を評価する。

2. 脳卒中患者の活動の回復に対する全体のリハビリ時間（分）の違いを評価する。

3. リハビリのスケジュールが、a. 週の平均リハビリ時間（分）、b. 週のリハビリの頻度、c. リハビリの全期間に関して活動に及ぼす影響を評価する。

Search methods

We searched the Cochrane Stroke Group trials register, CENTRAL, MEDLINE, Embase, eight other databases, and five trials registers to June 2021. We searched reference lists of identified studies, contacted key authors, and undertook reference searching using Web of Science Cited Reference Search.
Search methods
検索方法
Cochrane Stroke Groupの試験登録、CENTRAL、MEDLINE、Embaseなどのデータベースと5つの試験登録を2021年6月まで検索しました。我々は、特定された研究の参考文献リストを検索し、主要な著者に連絡を取り、Web of Science Cited Reference Searchを使用して参考文献検索を行いました。

Selection criteria

We included randomised controlled trials (RCTs) of adults with stroke that compared different amounts of time spent, greater than zero, in rehabilitation (any non‐pharmacological, non‐surgical intervention aimed to improve activity after stroke). Studies varied only in the amount of time in rehabilitation between experimental and control conditions. Primary outcome was activities of daily living (ADLs); secondary outcomes were activity measures of upper and lower limbs, motor impairment measures of upper and lower limbs, and serious adverse events (SAE)/death.
Selection criteria
選択基準
脳卒中を患う成人を対象としたランダム化比較試験(RCT)を含めました。これらの研究は、リハビリの時間だけで実験群と対照群との間に差がありました。主な結果は日常生活動作(ADL)、二次的な結果は上肢・下肢の活動測定、上肢・下肢の運動障害測定、および重篤な有害事象(SAE)/死亡でした。

Data collection and analysis

Two review authors independently screened studies, extracted data, assessed methodological quality using the Cochrane RoB 2 tool, and assessed certainty of the evidence using GRADE. For continuous outcomes using different scales, we calculated pooled standardised mean difference (SMDs) and 95% confidence intervals (CIs). We expressed dichotomous outcomes as risk ratios (RR) with 95% CIs.
Data collection and analysis
データの収集と分析
2人のレビューアが独立して研究をスクリーニングし、データを抽出し、Cochrane RoB 2ツールを使用して方法論的品質を評価し、GRADEを使用して証拠の確からしさを評価しました。異なる尺度を使用して連続的な結果のため、我々はプールされた標準化された平均差(SMD)と95%の信頼区間(CI)を計算しました。2値の結果はリスク比(RR)と95% CIで表現しました。

Main results

The quantitative synthesis of this review comprised 21 parallel RCTs, involving analysed data from 1412 participants.

Time in rehabilitation varied between studies. Minutes provided per week were 90 to 1288. Days per week of rehabilitation were three to seven. Duration of rehabilitation was two weeks to six months. Thirteen studies provided upper limb rehabilitation, five general rehabilitation, two mobilisation training, and one lower limb training. Sixteen studies examined participants in the first six months following stroke; the remaining five included participants more than six months poststroke. Comparison of stroke severity or level of impairment was limited due to variations in measurement.

The risk of bias assessment suggests there were issues with the methodological quality of the included studies. There were 76 outcome‐level risk of bias assessments: 15 low risk, 37 some concerns, and 24 high risk.

When comparing groups that spent more time versus less time in rehabilitation immediately after intervention, we found no difference in rehabilitation for ADL outcomes (SMD 0.13, 95% CI −0.02 to 0.28; P = 0.09; I2 = 7%; 14 studies, 864 participants; very low‐certainty evidence), activity measures of the upper limb (SMD 0.09, 95% CI −0.11 to 0.29; P = 0.36; I2 = 0%; 12 studies, 426 participants; very low‐certainty evidence), and activity measures of the lower limb (SMD 0.25, 95% CI −0.03 to 0.53; P = 0.08; I2 = 48%; 5 studies, 425 participants; very low‐certainty evidence). We found an effect in favour of more time in rehabilitation for motor impairment measures of the upper limb (SMD 0.32, 95% CI 0.06 to 0.58; P = 0.01; I2 = 10%; 9 studies, 287 participants; low‐certainty evidence) and of the lower limb (SMD 0.71, 95% CI 0.15 to 1.28; P = 0.01; 1 study, 51 participants; very low‐certainty evidence). There were no intervention‐related SAEs. More time in rehabilitation did not affect the risk of SAEs/death (RR 1.20, 95% CI 0.51 to 2.85; P = 0.68; I2 = 0%; 2 studies, 379 participants; low‐certainty evidence), but few studies measured these outcomes.

Predefined subgroup analyses comparing studies with a larger difference of total time spent in rehabilitation between intervention groups to studies with a smaller difference found greater improvements for studies with a larger difference. This was statistically significant for ADL outcomes (P = 0.02) and activity measures of the upper limb (P = 0.04), but not for activity measures of the lower limb (P = 0.41) or motor impairment measures of the upper limb (P = 0.06).
Main results
主な結果
このレビューの定量的な合成は、1412人の参加者からのデータを分析した21の平行RCTから構成されていました。
リハビリの時間は研究ごとに異なっていました。提供される分は、週に90から1288でした。リハビリの日数は、週に3日から7日でした。リハビリの期間は2週間から6ヶ月でした。13の研究が上肢のリハビリを、5の研究が一般的なリハビリを、2の研究が移動トレーニングを、1の研究が下肢のトレーニングを提供しました。16の研究は脳卒中後の最初の6ヶ月の参加者を調査し、残りの5つはそれ以上の期間の参加者を含めました。

Authors' conclusions

An increase in time spent in the same type of rehabilitation after stroke results in little to no difference in meaningful activities such as activities of daily living and activities of the upper and lower limb but a small benefit in measures of motor impairment (low‐ to very low‐certainty evidence for all findings). If the increase in time spent in rehabilitation exceeds a threshold, this may lead to improved outcomes. There is currently insufficient evidence to recommend a minimum beneficial daily amount in clinical practice. The findings of this study are limited by a lack of studies with a significant contrast in amount of additional rehabilitation provided between control and intervention groups.

Large, well‐designed, high‐quality RCTs that measure time spent in all rehabilitation activities (not just interventional) and provide a large contrast (minimum of 1000 minutes) in amount of rehabilitation between groups would provide further evidence for effect of time spent in rehabilitation.
Authors' conclusions
著者の結論
脳卒中後の同じタイプのリハビリに費やす時間の増加は、日常生活動作や上肢・下肢の活動などの意味のある活動にはほとんど影響せず、運動障害の測定にはわずかな利益があります(すべての所見に対する低〜非常に低い確信度)。リハビリに費やす時間が一定の閾値を超えると、結果が改善する可能性があります。現在のところ、臨床実践での最小限の有益な毎日の量を推奨するための十分な証拠はありません。この研究の所見は、介入群と対照群の間で提供される追加のリハビリの量に大きな差がある研究が不足していることによって制限されています。
すべてのリハビリ活動の時間を測定し、群間でのリハビリの量に大きな対照（最小で1000分）を提供する、大規模で設計が良好で高品質なRCTは、リハビリに費やす時間の効果に関するさらなる証拠を提供するでしょう。