An Exploratory Study of a Wearable Robotic Hand Orthosis in the Chronic Stroke Population in Singapore: A Clinic to Home Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Action Research Arm Test (ARAT) Score
研究概览
简要总结
Upper limb deficits usually remain in 75% of the stroke survivors despite completing full rehabilitation. This is due to lack of effectiveness of rehabilitation and the degree of support and resources available.
In this study, the investigators plan to study the use of assistive technologies in chronic stroke survivors.
详细描述
Assistive technologies have shown promising results in immediate improvement in functional abilities.
RELab tenoexo is a fully wearable and portable robotic hand orthoses (RHO) used for functional training. Its design support end users with functional hand opening and closing and can be applied in therapy exercises or during functional activities. While prior research demonstrated its effectiveness for spinal cord injury, it hasn't been tailored for multi-ethnic stroke populations.
This study aims to determine the feasibility and extent to which the RELab tenoexo can complement therapy training in clinic and further be used as both a training and assistive device in the home environment. In addition, it also aims to investigate the amount of upper limb usage before, during and after the training period.
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
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with first ever clinical stroke (ischaemic or haemorrhagic) with hemiplegic motor deficit(s) due to stroke as diagnosed by CT or MRI.
- •Post stroke of at least 6 months with stable neurological status.
- •Age 21 to 80 years of age.
- •Hemiplegic pattern and shoulder abduction MRC motor power > 2/5 and elbow extension >2/5
- •Has a stable home abode and a carer/NOK to assist with donning of device and supervise home based exercise
- •MOCA > or equal to 22/30
- •Able to give and sign informed consent at research site.
- •Able to speak English
排除标准
- •Non-stroke related causes of arm motor impairment.
- •Has unstable or terminal medical conditions which may affect participation (e.g.: unresolved sepsis, postural hypotension, end stage renal failure, cancer, retroviral disease, on immunosuppressive therapy) or anticipated life expectancy of <1 year due to malignancy or neurodegenerative disorder.
- •Local factors which may be worsened by intensive arm therapy: spasticity of Modified Ashworth Scale grades 3-4, skin wounds, shoulder pain Pain Scale >5/10, active/non-united fractures or arthritis or fixed joint/tissue flexion contractures of shoulder, elbow, wrist or fingers incompatible with tenoexo interface.
- •Patient with severe cognitive, perceptual (include hemi-neglect), and/or emotional-behavioural issues that preclude participation.
- •Experiencing moderate to severe levels of pain (Numerical Vertical Pain Scale > 5).
- •Is pregnant or breast feeding. Neither the tenoexo nor the IMUs have been tested to evaluate the usage with pregnant and/or breast feeding mothers. Further, due to the length of the study, pregnancy may make it difficult to follow the study schedule.
- •Have a pacemaker. Magnets are used throughout the system.
结局指标
主要结局
Action Research Arm Test (ARAT) Score
时间窗: Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
Functional and dexterity score in the affected arm evaluated using 19 tests of motor function across 4 subsets; minimum score = 0, maximum score = 57, with higher score indicating better function.
次要结局
- Hr-QOL scales using SS-QOL (Stroke specific Quality of Life scale)(Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment))
- EQ-5D-5L scale(Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment))
- Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)(Week 3 (mid in-clinic training), 4 (end of in-clinic training), 8 (end of home training))
- Grip Strength (kg)(Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment))
- Fugl-Meyer Motor Assessment (FMA) scale(Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment))
- Self-efficacy outcomes by UPSET (upper limb self-efficacy test)(Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment))
- System Usability Scale (SUS)(Week 3 (mid in-clinic training), 4 (end of in-clinic training), 8 (end of home training))