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临床试验/NCT02807740
NCT02807740已完成不适用

To Rehabilitate With Virtual Reality: To Evaluate the Effect of Virtual Reality on Cardiocirculatory System and on Balance in a Sample of Healthy Subject and Patients Affected by Parkinson Disease

Fondazione Don Carlo Gnocchi Onlus2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Change from Baseline Balance Berg Scale (BBS)

研究概览

简要总结

Patients affected by Parkinson disease (PD) can benefit from rehabilitation although the evidences are scattered. In the last years there are increased evidences that virtual reality can improve functional outcome in Parkinson's disease. No evidences are known concerning the cardiological safety and effect on balance of Virtual Reality. The aim of this study is to compare a virtual reality rehabilitation program versus a conventional one in a sample of patients affected by mild to moderate Parkinson and to collect data on cardiological effects.

详细描述

This study will be a prospective, single-blinded, randomized controlled trial aimed to compare two different rehabilitation programs in PD disease and to evaluate the effect of Virtual Reality on cardiocirculatory system.

Patients will undergo Conventional or Virtual Reality Rehabilitation Program for 6 consecutive weeks, 3-times in a week for a 40 minute session. Moreover, in order to acquire data on cardiocirculatory system during the first and the last sessions an Holter- electrocardiography will be used. Data will be compared with healthy subjects (matched for age and gender).

The used protocols are reported below.

Conventional (C) Rehabilitation Program The Conventional rehabilitation program will be performed according to the " Royal Dutch Society for Physical Therapy Guidelines for physical therapy in patients with Parkinson's disease". In each C rehabilitation session, patients will undergo 3 phases: 1) Warm-up phase: passive mobilization of main joints and muscular strengthen of lower limbs; 2) Active phase (both standing than seated): exercises of motor coordination with upper and lower limbs, balance training, start and stop exercises, deambulation training; 3) cool-down phase (with seated patient): manipulation exercises, mobilization exercises, respiratory exercises.

Virtual Reality (VR) Rehabilitation Program Each session will consist of multiple exercises. These ones are described below, each exercise will be performed by the patient for 4 minutes followed by a 1 minute of rest.

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)

入排标准

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

入选标准

  • Patients affected by mild to moderate PD, according to motor examination section (Part III) of the Unified Parkinson's Disease Rating Scale (UPDRS III)
  • ability to independently perform motor rehabilitation
  • absence of cognitive impairment (MMSE >25)

排除标准

  • severe hearing loss and/or visual deficit
  • serious comorbidity making impossible to perform rehabilitation (postural hypotension, heart disease, stroke, severe shoulder-hip disease)

结局指标

主要结局

Change from Baseline Balance Berg Scale (BBS)

时间窗: Patients will be evaluated at baseline (T0) and at the end of each rehabilitation program (T1), lasting 6 weeks

It is a 14-item scale that rates each function from 0 (worst) to 4 (best) along a dependence-independence continuum. This summative scale measures balance abilities seen during tasks involving sitting, standing, and positional changes. Total scores are indicative of overall balance abilities, with scores interpreted in the following manner: 0 to 20, wheelchair bound; 21 to 40, walking with assistance; and 41 to 56, independent.This scale has been previously validated in PD patients

次要结局

  • Change from Baseline Disabilities of the arm, shoulder and hand scale (DASH)(Patients will be evaluated at baseline (T0) and at the end of each rehabilitation program (T1), lasting 6 weeks)
  • Change from Baseline Dynamic gait index (DGI)(Patients will be evaluated at baseline (T0) and at the end of each rehabilitation program (T1), lasting 6 weeks)

研究者

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

Costanza Pazzaglia

Researcher

Fondazione Don Carlo Gnocchi Onlus

研究点 (2)

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