跳至主要内容
临床试验/NCT05773885
NCT05773885招募中不适用

Home Telerehabilitation Based on Serious Games for Continuity of Care in People With Parkinson's Disease

IRCCS San Raffaele Roma4 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
4
主要终点
Change in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) - part II

研究概览

简要总结

Although TeleRehabilitation (TR) is widely accepted as an appropriate model for the provision of professional health services in the field of physiotherapy, with already established standards, guidelines and policies, there are still few studies in the literature on the use of TR as a rehabilitation tool in people with Parkinson's Disease (PD). Therefore, further studies on the efficacy of TR in the management of motor and non-motor symptoms of PD are needed.

The study TEMPO aims at assessing the efficacy (in terms of autonomy in carrying out the activities of daily life) of a home TR program based on serious games in people with PD compared to conventional day-hospital treatment.

详细描述

The scientific literature has shown that appropriate exercise can decrease some non-motor symptoms of PD such as fatigue, depression, apathy, and cognitive impairment, and it can positively affect motor performance. However, access to rehabilitation centers is often difficult, with logistic and economic barriers for those not living near a specialized hospital. In recent years, the use of technologies has considerably progressed, and, with the development of telemedicine systems, remote treatments have become a viable option for the management of patients with PD.

The TR has the potential to optimize the timing, intensity, and personalization of rehabilitation intervention and offers the opportunity for a flexible implementation of treatment protocols and the ability to monitor patient progress in real-time. In particular, for patients with neurological degenerative pathologies, who need periodical and tailored rehabilitation for the whole life, the TR has proved feasible and effective. The recent systematic review by Vellata found that the literature on TR in people with PD is limited. The published studies on TR for PD showed that it is feasible and effective in maintaining and/or improving some clinical and non-clinical aspects of PD such as: balance and walking, speech and voice, quality of life, patient satisfaction. However, although TR is widely accepted as an appropriate model for the provision of professional health services in the field of physiotherapy, with already established standards, guidelines and policies, there are still few studies in the literature on the use of TR as a rehabilitation tool in people with Parkinson's disease.

In this context, the efficacy of TR in the management of motor and non-motor symptoms of PD has to be further investigated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

The outcome assessor will be blind to the study protocol

入排标准

年龄范围
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age between 30 and 80 years;
  • diagnosis of Parkinson's Disease according to the "Movement Disorders Society's diagnostic criteria";
  • Hoehn & Yahr (H&Y) score between 2 and 3 (ON-state);
  • absence of dyskinesias assessed by the MDS-UPDRS with a score to items 4.1 and 4.2 ≤ 2;
  • absence of cognitive impairment measured by the MoCA total score ≥ 18;
  • stabilized drug treatment;
  • have access to the Internet for TR;
  • have a caregiver available during rehabilitation sessions in TR;
  • have sufficient cognitive and linguistic level to understand and comply with study procedures;
  • sign informed consent.

排除标准

  • having any cognitive problems or low compliance that prevent using the TR system;
  • other neurological pathologies, psychiatric complications or personality disorders;
  • musculoskeletal diseases that impair movement;
  • presence of dyskinesias assessed by the MDS-UPDRS with a score to items 4.1 and 4.2 > 2;
  • presence of cognitive impairment measured by the MoCA total score < 18;
  • severe cognitive or linguistic deficits (inability to understand and comply with study procedures);
  • presence of blurred or low vision problems;
  • hearing and speech impairment affecting participation in the system;
  • absence of signature of the informed consent.

结局指标

主要结局

Change in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) - part II

时间窗: Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1) and a follow-up (2 months after the end of the treatment, T2)

MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part II assessed motor experiences of daily living (Range 0-52). A higher score indicated more severe symptoms of PD.

次要结局

  • Change in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)(Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1) and a follow-up (2 months after the end of the treatment, T2))
  • Change in the Parkinson's Disease Questionnaire-8 (PDQ-8)(Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1) and a follow-up (2 months after the end of the treatment, T2))
  • Change in the Montreal Cognitive Assessment (MoCA)(Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1))
  • Change in the Lee Silverman Voice Treatment LOUD assessment (LSVT/LOUD)(Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1))
  • Change in the Timed Up and Go test (TUG)(Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1))
  • Change in the Timed Up and Go Dual task test (TUG-D)(Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1))
  • Change in the mini-Balance Evaluation Systems Test (mini-BESTest)(Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1))
  • Change in the Activities-specific Balance Confidence scale (ABC)(Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1) and a follow-up (2 months after the end of the treatment, T2))
  • Change in the 10-meter WalkTest (10mWT)(Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1))
  • Change in the New Freezing of Gait Questionnaire (NFOG-Q)(Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1) and a follow-up (2 months after the end of the treatment, T2))

研究者

发起方
IRCCS San Raffaele Roma
申办方类型
Other
责任方
Sponsor

研究点 (4)

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