Efficacy of an Interactive Web-Based Home Therapy Program in the Recovery of Arm and Hand Function Following Stroke: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Wolf Motor Function Test Short Battery
研究概览
简要总结
This is an online study that involves assessment and training of arm function at home. Stroke is the leading cause of disability worldwide. Of the annual incidence of stroke (~750,000) in the USA about 60% fail to recover arm and hand use contributing to reduced quality of life for survivors and caregivers. How can therapists facilitate the rehabilitation of individuals with arm movement deficits and increase their quality of life over a long time period? It is known that principles of treatment including repetition, feedback, challenge and progression are important for producing recovery. The ability for patients to train at home and manage their own rehabilitation duration, intensity and progression, via effective self-management strategies, is vital. What is needed is an effective, easy to use, low cost system that self-motivates patients to intensively practice their therapy exercises at home while maintaining elements of repetition, feedback, challenge and progression. In this proposal the investigators intend to adapt just such a "web-based system" originally designed in the UK. The first version of the system has shown preliminary efficacy and feasibility in a small pilot study in UK. The investigators will adapt the system for use in the USA, with the assistance of consultants from the UK.
The purpose of this study is to investigate the efficacy and feasibility of using a free, easy to use, interactive web-based upper extremity stroke rehab program on individuals with stroke who have been discharged from outpatient rehabilitation. The goal is to compare the home use of the web-based stroke rehab program with that of written exercises in a randomized controlled trial. The aims/objectives are to (1) adapt the existing system for use in America including adding bilateral activities and then to assess (2) motor function immediately before and after six weeks intervention and after 12 weeks follow up in order to support the efficacy of using this web-based intervention; (3) behavioral changes in motivation and self-efficacy at the same time points to understand the relationship between behavioral and motor function changes; (4) perceptions of patients and caregivers of the web-based program to understand feasibility and barriers to home use; and (5) perceptions of therapists to understand feasibility and barriers to clinic use.
详细描述
Objective 1, Development of the expanded STROKE web program applicable to individuals with stroke in the USA.
This is a necessary objective to achieve before the investigators can start the trial; but it has no associated hypothesis. One rationale is to expand the target population in terms of impairment severity based both on feedback from therapists and on the need to add more bilateral activities that are important for everyday use. The second rationale is to check that material is readable and applicable to individuals with stroke in the USA.
Objective 2: To determine the immediate and durable motor function changes from a six-week web-based stroke rehab program vs. usual written exercise care in individuals discharged from outpatient therapy after a stroke.
H1: Six weeks of web-based stroke training compared to six weeks of a written home upper limb exercise program will result in clinically meaningful and statistically significant improvement in upper extremity function immediately after the intervention and 12 weeks later.
This primary hypothesis is justified based on the combination of two theoretical constructs as described earlier. First, there is evidence that web-based programs, based on Self Determination Theory principles, will show an increase in motivation to exercise vs. a control with no intervention in non-disabled individuals. Second, since the web-based program is also based on neuroplasticity and motor learning principles known to improve functional recovery, and not just physiological improvements, the participants should also improve their functional recovery rather than merely gain physical activity benefits while maintaining or even losing their functional level. Third, the pilot feasibility study supports this hypothesis for the immediate effect and, after the power analysis, for the follow up testing.
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion:
- •Individuals over 30 years who have Ischemic or Hemorrhagic stroke:
- •Discharged from outpatient rehabilitation
- •Impaired upper limb function: Participants must have recognizable (observable) dysfunction. They should also have the ability to move their hand forward by at least 3 inches without trunk compensation and demonstrating anti-gravity movement.
- •Must have a computer or tablet with internet access and also capability of video recording the study participant.
- •Able to provide informed consent.
- •Participants needs to have enough cognitive and communication function to understand instructions from the web-based program.
排除标准
- •Co-morbidities such as neurological, orthopaedic and cardiovascular complications that compromise safety and participation
- •Severe cognitive and communication problems indicated by failure to respond to two-step commands: Participants must be able to interact with the web-based intervention.
- •Indications of a cerebellar stroke as detected by the screening of impaired upper limb function.
结局指标
主要结局
Wolf Motor Function Test Short Battery
时间窗: Change after 6 weeks training and 4.5 months after training
Upper extremity function measure- 6 timed tasks - Up to 2 mins per task permitted. Shorter time indicates better outcome
次要结局
- Stroke Rehabilitation Motivation Scale(Measured at baseline, after 6 weeks, and after 12 weeks of training)
- Amount of Practice(Measured throughout training)
- Stroke Self-Efficacy Questionnaire(Measured at baseline, after 6 weeks, and after 12 weeks of training)
- Motor Activity Log(Measured at baseline, after 6 weeks, and after 12 weeks of training)
- Fugl Meyer Upper Extremity Motor Performance(Measured at baseline, after 6 weeks, and after 12 weeks of training)
研究者
Kelly Westlake
Associate Professor
University of Maryland, Baltimore