《中国康复理论与实践》

《中国康复理论与实践》 ›› 2023, Vol. 29 ›› Issue (7): 816-821.doi: 10.3969/j.issn.1006-9771.2023.07.011

• 循证研究 • 上一篇    下一篇

帕金森病步态异常非药物康复循证研究：基于ClinicalTrials.gov数据库分析

王靖萱1,2, 吕迪阳1(), 方伯言1   

  1. 1.首都医科大学附属北京康复医院，北京市 100144
    2.首都医科大学北京康复医学院，北京市 100144
  • 收稿日期:2023-02-21 修回日期:2023-06-01 出版日期:2023-07-25 发布日期:2023-08-30
  • 通讯作者: 吕迪阳(1994-)，男，汉族，博士，主要研究方向：神经系统退行性疾病。E-mail： lyudiyang@163.com
  • 作者简介:王靖萱(2002-)，女，满族，北京市人，本科生。
  • 基金资助:
    1.国家重点研发计划项目(2022YFC3602603);2.首都医科大学附属北京康复医院科技发展专项(2020-069);2.首都医科大学附属北京康复医院科技发展专项(2021-011);2.首都医科大学附属北京康复医院科技发展专项(2022R-002)

Non-drug rehabilitation for gait abnormality of Parkinson's disease: a review based on ClinicalTrials.gov

WANG Jingxuan1,2, LÜ Diyang1(), FANG Boyan1   

  1. 1. Beijing Rehabilitation Hospital, Capital Medical University, Beijing 100144, China
    2. Beijing Rehabilitation Medical College, Capital Medical University, Beijing 100144, China
  • Received:2023-02-21 Revised:2023-06-01 Published:2023-07-25 Online:2023-08-30
  • Contact: LÜ Diyang, E-mail: lyudiyang@163.com
  • Supported by:
    National Key Research and Development Program(2022YFC3602603);Beijing Rehabilitation Hospital, Capital Medical University Scientific Research Fund(2020-069);Beijing Rehabilitation Hospital, Capital Medical University Scientific Research Fund(2021-011);Beijing Rehabilitation Hospital, Capital Medical University Scientific Research Fund(2022R-002)

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摘要：

目的 了解非药物疗法治疗帕金森病步态异常的相关临床试验进展。

方法 检索临床试验注册平台ClinicalTrials.gov建库至2022年10月25日注册的有关非药物疗法治疗帕金森病步态异常的临床试验。两名研究人员独立对试验进行筛选，收集相关信息并对数据根据PICOS原则进行分析，包括注册时间、注册数量、样本量、干预措施、主要结局指标、研究设计等。

结果 最终纳入临床试验218项。近年来该领域临床试验注册数呈上升趋势。大部分临床试验的样本量< 100例(93.6%)，主要为21~30例。主要干预措施为神经调控技术，虚拟现实技术、机器人辅助训练技术也逐渐被采用。主要结局指标为评定量表、评定问卷和运动测试。试验设计以随机平行对照试验为主(111项，50.9%)。

结论 非药物疗法治疗帕金森病步态异常的临床试验注册数逐年增加，随着科学技术的发展，虚拟现实技术、机器人辅助训练技术等新的治疗方法可能成为研究主流。

关键词: 帕金森病, 康复, 临床试验, 临床试验注册平台

Abstract:

Objective To investigate the current trend of non-drug therapy for gait abnormality of Parkinson's disease.

Methods The clinical trials about non-drug therapy for gait abnormality of Parkinson's disease were retrieved from the clinical trial registration platform ClinicalTrials.gov, from inception to October 25th, 2022. The records were screened by two researchers independently, and the registration time, registration count, sample sizes, interventions, primary outcome measurements and study design, etc., were summarized and analyzed, according to the PICOS principle.

Results A total of 218 eligible records were included. The registration count increased in recently years. Almost all of the trials (93.6%) were with a relatively small sample size less than 100, mainly 21 to 30 cases. The major intervention approach was the neuromodulation technique, however, virtual reality and robot-assisted gait training were coming to use in recent years. The primary outcome measurements were the clinical scales, the questionnaires and the exercise examinations. Randomized parallel controlled trials were the most (111, 50.9%).

Conclusion The number of non-drug therapy for gait abnormality of Parkinson's disease increased year by year. The new technologies such as virtual reality and robot-assisted gait training may be used more in the future.

Key words: Parkinson's disease, rehabilitation, clinical trials, clinical trial registration platform

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