跳至主要内容
临床试验/NCT03886480
NCT03886480Unknown不适用

Investigating the Effects of Virtual Occupations on Upper Extremity Recovery Using the Saebo VR Rehabilitation System in Stroke Survivors: a Multiple Single-subject Design Evaluation

University of Manitoba1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2019年4月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
2
试验地点
1
主要终点
Canadian Occupational Performance Measure

研究概览

简要总结

The purpose of this study is to explore the efficacy of the SaeboVR rehabilitation system for improving functional outcomes related to upper extremity motor recovery in stroke survivors.

The specific objectives are:

  1. To explore the participants' level of performance and satisfaction with their performance in self-identified problem areas of daily functioning following a 4-week intervention using the SaeboVR rehabilitation system.
  2. To evaluate the efficacy of an intervention protocol that emphasizes task-specific and goal-oriented virtual practice, reflecting the participants' self-identified goal priorities.

详细描述

This study will employ a multiple single-subject pre-post experimental design, with multiple pre and post measures, to evaluate the potential efficacy of a virtual reality-based treatment using the SaeboVR rehabilitation system in stroke survivors. Comprehensive measurement during the baseline and post-treatment phases will be completed, with each individual to serve as their own control. Participants will make 3 separate visits to the laboratory (approximately 2 days apart) on the Bannatyne Campus at the University of Manitoba prior to the 4 week intervention and again after the intervention. The Arm Activity Measure (ArmA) and the Fugl-Meyer Assessment of Upper Extremity (FMA-UE) will be used both pre and post intervention as well as the Canadian Occupational Performance Measure (COPM) to measure participants' performance on self-identified occupational performance issues and their level of satisfaction with their performance. Two participants will be recruited upon discharge from inpatient stroke rehabilitation at the Riverview Health Centre, Winnipeg, Manitoba, and upon entry into this study, will receive one-to-one treatment and supervision using the SaeboVR rehabilitation system for approximately 1 hour per session, 2 to 3 times per week for 4-weeks.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • •adults aged 18 or over with upper extremity deficits post stroke
  • •admitted to Riverview Health Centre (Winnipeg, Canada) for stroke rehabilitation and are being discharged to home locations within the city of Winnipeg
  • •referred to outpatient Occupational Therapy at the Health Sciences Centre (Winnipeg, Canada) for additional upper extremity retraining post-stroke
  • •have a premorbid fully functional upper extremity
  • •have anti-gravity strength of the affected elbow to at least 45 degrees of active flexion when in an upright seated position
  • •have anti-gravity strength of the affected shoulder to at least 30 degrees of active flexion and active abduction/adduction when in an upright seated position
  • •have active internal and external shoulder rotation of the affected shoulder to at least 15 degrees when in an upright seated position
  • •able to speak and understand English
  • •able to follow verbal instructions
  • •have normal visual acuity with corrective lenses
  • •have no noted visual neglect

排除标准

  • •have a history of seizure
  • •have arthritis or pain restricting repetitive training of the affected upper extremity

研究组 & 干预措施

SaeboVR

Experimental

Use of the SaeboVR for task specific upper extremity training

干预措施: SaeboVR (Device)

结局指标

主要结局

Canadian Occupational Performance Measure

时间窗: Change from baseline perception of occupational performance to 4 weeks

The Canadian Occupational Performance Measure (COPM) is a valid and responsive measure of occupational performance and has been widely used in stroke research. The COPM uses a semi-structured interview format where performance and satisfaction scores will be identified for the participants' self-identified occupational performance issues.

次要结局

  • Fugl-Meyer Assessment-Upper Extremity (FMA-UE)(Change from baseline upper extremity impairment to 4 weeks)
  • Arm Activity Measure(Change from baseline upper extremity function to 4 weeks)

研究者

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

Brenda Semenko

Sessional Instructor

University of Manitoba

研究点 (1)

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