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临床试验/NCT02764372
NCT02764372已完成1 期

Serious Games for Upper Extremity Rehabilitation for Patients With Neurological Disorders: A Pilot Study

Fondazione Don Carlo Gnocchi Onlus0 个研究点目标入组 20 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
20
主要终点
9 Hole peg test

研究概览

简要总结

The aims of the present study were to:

  • Investigate the feasibility of using a therapeutic gaming system (REHAB@HOME), based on Kinect, to augment upper extremity neurorehabilitation services.
  • Provide preliminary evidence of clinical efficacy of the approach in increasing arm activity and health related quality of life of persons post stroke or with MS.

Main results suggest that the serious games approach was positively received in terms of user experience and motivation to use, with the participants showing also improvements in functional abilities of the treated arm.

详细描述

The objective of this pilot study was to assess the feasibility of using a therapeutic gaming system (REHAB@HOME), based on Kinect, to augment upper extremity neurorehabilitation services. A secondary objective was to provide preliminary evidence of clinical efficacy of the approach in increasing arm activity and health related quality of life of persons post stroke or with multiple sclerosis (MS).

A pilot single-blind randomized controlled trial was carried out in an inpatient and ambulatory care at a rehabilitation center. Twenty persons with multiple sclerosis (n=16) or chronic poststroke (n=4) receiving rehabilitation at the center, able to flex shoulder and elbow at least 45 degrees, participated in the study.

An intervention group received Serious Games-based upper extremity therapy for a total of 12 sessions (4-5 sessions, lasting 40 minutes, per week) and the control played the same amount of time with commercial exergames of the Wii. Both groups received their usual rehabilitation services as well as game playing.

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

入选标准

  • Persons Post stroke or with MS with resultant upper extremity motor deficits.
  • Range of motion of shoulder and elbow equal or higher than 45 degrees.
  • Able to comprehend and follow directions.

排除标准

  • Wearing pace maker
  • Comorbidities affecting arm use
  • Not able to comprehend and follow directions

结局指标

主要结局

9 Hole peg test

时间窗: 10 months

Testing pre and post intervention

Box and Block test

时间窗: 10 months

Testing pre and post intervention

次要结局

  • Short Form 12(10 months)
  • the EQ-5D visual analogue scale (EQ-VAS)(10 months)

研究者

申办方类型
Other
责任方
Sponsor

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