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临床试验/NCT05762562
NCT05762562已完成不适用

Parkinson Disease Telerehabilitation Program (PDTR): a Home-motor Program for Parkinson's Disease With Open-source Platforms. A Pilot Study.

Istituti Clinici Scientifici Maugeri SpA1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
33
试验地点
1
主要终点
The opportunity of the usage TR in PD patients by using free open-source platforms

研究概览

简要总结

Parkinson's disease (PD) leads to multifactorial disabilities with consequent social restrictions, especially in the COVID-19 era. Continuity of care, especially rehabilitation measures, is critical to improve or maintain an adequate QoL for patients. The Parkinson Disease Telerehabilitation Program (PDTR) is an individualized home rehabilitation program using open-source platforms (OSp).

The main purpose of this pilot study is to investigate the feasibility of TR in patients with PD by using free OS platforms (PDTR PROGRAM).

The target of this study was to have at least 90% of participants completing the program. To complete the program every single patient had to complete at least 80% of the prescribed TR sessions.

详细描述

Participants were PD patient afferent to the Neurology ambulatory. Patients underwent an initial evaluation (T0) by the neurologist and physiotherapist. During T0, also the level of digital literacy was evaluated

Participants included in the study were separated into three groups based on their residual motor skills evaluated by the Short Physical Performance Battery (SPPB).

Each group corresponded to a Program (Pr). SPPB score between 12 and 10: Pr. A for patients with capable motor skills; they were were associated to the TR program A (TrP.A).

SPPB score between 9 and 7: Pr. B for patients with reduced motor skills; they were were associated to the TR program B (TrP.B).

SPPB score lower than 7: Pr. C for patients who didn't show having sufficient motor skills; they were were associated to the telemonitoring program C (TmP.C) without any exercise program.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

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

入选标准

  • Hoehn & Yahr (H&Y) score between 1 and 3;
  • being on drug treatment stabilized with L-Dopa or dopamine agonists;
  • being able to walk independently (with or without help)
  • having adequate computer knowledge, be able to use online communication platforms and to undertake a continuous 8-weeks program.

排除标准

  • Montreal Cognitive Assessment screening test score below 17.54
  • having unpredictable motor fluctuations or non-pharmacologically controlled dyskinesias
  • having neurological pathologies superimposed on PD; or cognitive, sensory, psychiatric alterations such as to make it impossible to understand and execute the exercises; or musculoskeletal and cardiopulmonary diseases that compromise mild physical activity.

结局指标

主要结局

The opportunity of the usage TR in PD patients by using free open-source platforms

时间窗: 1 year

90% of participants completing the program. To complete the program every single patient had to complete at least 80% of the prescribed TR sessions

次要结局

  • Patient's agreement(1 year)
  • Patient's satisfaction(1 year)
  • Maintenance of clinical outcomes - Walking speed(1 year)
  • Maintenance of clinical outcomes - Risk of falling(1 year)
  • Maintenance of clinical outcomes - Balance(1 year)
  • Perceived level of quality of life(1 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chiara Vellata

Physiotherapy

Istituti Clinici Scientifici Maugeri SpA

研究点 (1)

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