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临床试验/NCT04517812
NCT04517812已完成不适用

Consideration-of-concept of the VirtualRehab Platform for Delivery of Upper Limb Rehabilitation at Home for People Late After Stroke

University of East Anglia2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2018年7月18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
22
试验地点
2
主要终点
Surface Electromyography, change over intervention period

研究概览

简要总结

This study will deliver a 12-week exercise-based upper limb virtual reality, non-immersive, rehabilitation programme for stroke survivors. The aims are to:1. to assess the acceptability and usability of the VirtualRehab platform for delivery of stroke rehabilitation at home:

  1. to find if stroke survivors adhere to 'prescribed' use of the VirtualRehab platform over a 12-week period; 3. to assess the viability of using randomised length of baselines and repeated measures during the intervention period to inform subsequent study to find the optimum therapeutic dose 4. to estimate how a 12-week period of using the VirtualRehab platform could change motor impairment and functional capacity.

详细描述

Background and objectives:

This study is driven by the hypothesis that provision of task-orientated training via a non-immersive virtual reality platform enhances upper limb motor and neural function more than current routine physical therapy for people with stroke. Before this hypothesis can be tested in a randomised controlled clinical trial. If evidence of concept is found, then the next step is identification of the optimum therapeutic dose of exercised-based therapy delivered via the Virtualrehab Platform as a precursor to a clinical efficacy trial. The specific objectives of the study reported here were:

  1. to assess the acceptability and usability of the VirtualRehab platform for delivery of stroke rehabilitation at home:
  2. to find if stroke survivors adhere to 'prescribed' use of the VirtualRehab platform over a 12-week period;
  3. to assess the viability of using randomised length of baselines and repeated measures during the intervention period to inform subsequent study to find the optimum therapeutic dose
  4. to estimate how a 12-week period of

Design:

A series of replicated single case studies with an AB design (2.1). During the A, control, phase participants will not receive the experimental intervention. Participants will receive the experimental intervention during the B phase. At the beginning of the control phase, participants will complete the measurement battery. These will be the baseline-one measures. The measurement battery will be repeated at the end of the baseline phase (baseline-two) and at the end of the intervention phase (outcome). Progress measures will be made at the end of every week of the intervention (B) phase.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Other
盲法
None

盲法说明

masking not considered for this feasibility investigation

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Surface Electromyography, change over intervention period

时间窗: baseline 1, baseline 2, during intervention, post-intervention (up to 15 weeks)

Time to onset for muscle activity during a reaching task

Change in motor impairment, over intervention period

时间窗: baseline 1, baseline 2, during intervention, post-intervention (up to 15 weeks)

The Motricity Index (scores)

Change in functional ability, pre to post

时间窗: baseline 1, baseline 2, post-intervention (3 weeks)

The Wolf Motor Function Test (WMFT) scores

Change in motor impairment, pre to post

时间窗: baseline 1, baseline 2, post-intervention (3 weeks)

Hand grip force forces (KG) will be made using a Myometer.

Change in functional ability, over intervention period

时间窗: baseline 1, baseline 2, during intervention, post-intervention (up to 15 weeks)

iThe Action Reaction Arm Test (ARAT).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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