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强化和应用程序提供的职业治疗改善早期弥漫性皮肤系统性硬化症的上肢功能:一项试点双臂试验。

Intensive and app-delivered occupational therapy to improve upper extremity function in early diffuse cutaneous systemic sclerosis: a pilot two-arm trial.

机构信息

Department of Physical Medicine & Rehabilitation, University of Michigan.

VA Ann Arbor Healthcare System, Geriatric Research Education and Clinical Center, GRECC.

出版信息

Rheumatology (Oxford). 2021 Nov 3;60(11):5002-5011. doi: 10.1093/rheumatology/keab339.

Abstract

OBJECTIVE

SSc reduces upper extremity function and performance of everyday activities; however, there are few evidence-based rehabilitation interventions. This study examined short and longer-term effects of two occupational therapy interventions on hand disability.

METHODS

Participants with diffuse cutaneous SSc were randomized to one of two 18-week interventions: Intensive group, receiving eight weekly in-person occupational therapy sessions with App-delivered home exercises, or App Alone group. The primary outcome was QuickDASH hand disability; secondary outcomes were physical function (PROMIS scale), and total active hand motion. Linear mixed models were used to examine treatment effects.

RESULTS

Most participants were female (72%); the mean age was 52 years (13.4) (n = 32). There were no significant between-group effects on QuickDASH (P = 1.0; mean change -6.4 on 0-100 scale in both groups at 18 weeks). Left lateral pinch, an exploratory outcome, improved in App Alone compared with Intensive from baseline to 18 weeks. Within groups, the Intensive group had the largest improvements after 8 weeks (-8.5 on QuickDASH; P = 0.03), but then lost gains from 8 to 18 weeks while the App Alone group had modest improvements from baseline to 8 weeks, but then continued to improve. Of completers, 50% had clinically meaningful improvement on QuickDASH in the Intensive group and 64% had improvement in App Alone.

CONCLUSION

Both interventions showed beneficial effects on hand disability. Participants in the App Alone group improved equally to the Intensive group at 18 weeks. Our findings provide support for further study into telehealth rehabilitation approaches.

TRIAL REGISTRATION

NCT03482219.

摘要

目的

硬皮病会降低上肢功能和日常活动表现,但目前针对该疾病的康复干预措施较少。本研究旨在评估两种职业治疗干预措施对手部残疾的短期和长期影响。

方法

将弥漫性皮肤型硬皮病患者随机分为两组,分别接受为期 18 周的干预:密集组每周接受 8 次面对面的职业治疗,并结合应用程序提供的家庭练习;应用程序单独组仅接受应用程序干预。主要结局指标为快速残疾评定量表(QuickDASH)手功能障碍评分;次要结局指标包括身体机能(PROMIS 量表)和总主动手活动度。采用线性混合模型来检验治疗效果。

结果

大多数参与者为女性(72%);平均年龄为 52 岁(13.4)(n=32)。两组间 QuickDASH 评分无显著差异(P=1.0;两组在 18 周时的评分均为 0-100 分,平均变化值为-6.4)。在 App 单独组中,左手侧捏力这一探索性结局指标在基线至 18 周时优于密集组。组内比较,密集组在 8 周时的改善最大(QuickDASH 评分下降 8.5;P=0.03),但从 8 周到 18 周时,改善效果逐渐消失,而 App 单独组从基线至 8 周时适度改善,随后继续改善。在完成治疗的患者中,密集组有 50%的患者 QuickDASH 评分改善具有临床意义,而 App 单独组有 64%的患者改善。

结论

两种干预措施均对手部残疾有改善作用。在 18 周时,应用程序单独组与密集组的改善效果相当。我们的研究结果为远程康复方法的进一步研究提供了支持。

试验注册

NCT03482219。

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