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临床试验/NCT03171077
NCT03171077已完成不适用

Effectiveness of Virtual Rehabilitation and Proprioceptive Neuromuscular Facilitation in the Recovery of the Motor Function Post Stroke: A Randomized Clinical Trial

Federal University of Bahia1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年6月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Effectiveness of virtual rehabilitation and proprioceptive neuromuscular facilitation in the recovery of the motor function post stroke

研究概览

简要总结

The purpose of this study is to determine the effects of use the Nintendo Wii® (NW) and therapeutic exercises by the method Proprioceptive Neuromuscular Facilitation (PNF) in the recovery of the motor function of poststroke hemiparesis patients.

详细描述

Randomised clinical trial (RCT) will be held in following the recommendations of the CONSORT (Consolidated Standards of Reporting Trials). This RCT have longitudinal and prospective feature, held at the Neurosciences Clinic located at the Clinic Professor Francisco Magalhães Neto the HUPES Complex / Federal University of Bahia from June 2015 until June 2016.

In the initial evaluation were obtained by a trained examiner and blinded to the allocation of participants, all personal data of all patients, as well as evaluations of balance and quality of life through specific validated scales:

  1. Fugl Meyer scale (FMS);

The investigators employ an experimental program of therapeutic exercises for the PNF method and virtual rehabilitation with NW, for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age between 18 and 80 years, of both sexes; neurological clinical diagnosis of stroke;
  • owning grade 2-4 spasticity according to the Ashworth scale;
  • hemiparetic patients after 6 months of onset of stroke;
  • deficit moderate gait according to Functional Ambulation Classification (values ≥ 2).

排除标准

  • score <24 on the Mini Mental State Examination;
  • other associated neurological diseases, as well as orthopedic and no visual or hearing impairment;
  • participation in other rehabilitation programs.

研究组 & 干预措施

Virtual Rehabilitation

Active Comparator

A virtual rehabilitation program (G0) based on the use of the NW for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes.

The G0 treatment program consists of the following protocols: a) protocol 1 games (Balance Bubble Plus and Tennis); b) protocol 2 games (Rhythm Parade and Boxing).

干预措施: Virtual Rehabilitation (Other)

PNF Method

Experimental

A program of therapeutic exercises (G1) based on the PNF method for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes. The G1 treatment program consists of the following protocols: a) protocol 1 : 30 minutes diagonal exercise upper limb (flexion-abduction-external rotation and extension-abduction-internal rotation), and 10 minutes diagonal exercise scapula (anterior and posterior elevation); b) protocol 2: 20 minutes diagonal exercise lower limb (flexion-abduction-external rotation and flexion-abduction-internal rotation),10 minutes diagonal exercise pelvis (anterior and posterior depression), and 10 minutes gait cycle training;

干预措施: PNF Method (Other)

Virtual Rehabilitation and PNF Method

Active Comparator

In G2 program will be performed 20 minutes G0 protocol (1 or 2, used alternately between sessions a week) and 20 minutes G1 protocol (1 or 2, used alternately between sessions a week), taking the time of the performed activities halved in both protocols.

干预措施: Virtual Rehabilitation and PNF Method (Other)

结局指标

主要结局

Effectiveness of virtual rehabilitation and proprioceptive neuromuscular facilitation in the recovery of the motor function post stroke

时间窗: 8 weeks

Fugl-Meyer Assessment

次要结局

未报告次要终点

研究者

发起方
Federal University of Bahia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Vítor Antônio dos Santos Júnior

Master's Degree student

Federal University of Bahia

研究点 (1)

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