Smart Robot Therapy for Stroke Upper Limb Rehabilitation: A Proof-of-value Trial of Clinic to Home Robotics-assisted Telerehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Fugl Meyer Motor Assessment
研究概览
简要总结
Hemiparetic weakness is common after stroke and only a small group of patients achieve useful upper limb function despite best rehabilitation efforts. This is due to the lack of intensive upper limb therapies to drive neuroplasticity either in clinic or at home.
In this study, we plan to pilot home-based, robot-aided-therapy using H-man to deliver intensive arm rehabilitation.
详细描述
It has been assumed that stroke survivors reach a plateau in their recovery within 3-6 months of their stroke. They tend to receive minimal rehabilitation support once they are discharged to the community citing obstacles such as ambulation, transportation, and cost.
H-man is a novel telerehabilitation, upper limb training robot, that will deliver robot-aided therapy in patients' homes by clinic-based therapists through remote monitoring and under the supervision of their caregivers.
The study aims to refine and evaluate the feasibility, efficacy and safety of home-based training using the H-man robot.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical stroke (ischaemic or haemorrhagic) confirmed by admitting doctors and CT, CT angiography or MRI brain imaging (2) Age 21 to 90 years, both males and females (3) At least > 28 days (4) Upper limb motor impairment of Fugl-Myer Motor Assessment (FMA) scale 10 to 60 (5) Has a stable home abode and a carer/ NOK to supervise home based exercise. (6) Ability to sit supported continuously for 60 minutes (7) Montreal Cognitive Assessment (MOCA) score > 21/30 (8) Able to understand purpose of research and give consent
排除标准
- •Non-stroke related causes of arm motor impairment
- •Medical conditions incompatible with research participation: uncontrolled medical illnesses (hypertension or diabetes, ischaemic heart disease, congestive heart failure, bronchial asthma, severe /untreated depression, agitation, end stage renal/liver/heart/lung failure, unresolved cancers.
- •Anticipated life expectancy of < 6 months
- •Inability to tolerate sitting continuously for 60 minutes (5 Local factors potentially worsened by intensive robot-aided arm therapy and computer-based training: active seizures within 3 months, spasticity of Modified Ashworth Scale grades >2 skin wounds, shoulder, arm pain VAS >5/10, active upper limb fractures, arthritis, fixed upper limb flexion contractures.
- •(6) Hemi anaesthesia of affected limb (7) Severe visual impairment or visual neglect affecting ability to use H-Man robot (8) History of dementia, severe depression or behavioural problems (9) Pregnant or lactating females will not be allowed to participate (10) Absence of reliable carer to provide supervision during home training.
结局指标
主要结局
Fugl Meyer Motor Assessment
时间窗: Assessed at week 5 from baseline (week 0)
Change in Fugl Meyer Motor Assessment score in the affected arm
次要结局
- Grip strength (KgF) measured by Digital Dynamometer (mean of 3 readings will be recorded)(Assessed at weeks 0, 5, 12 and 24)
- Self-efficacy outcomes by UPSET (upper limb self-efficacy test)(Assessed at weeks 0, 5, 12 and 24)
- HrQOL scales using SS-QOL (Stroke specific Quality of Life scale)(Assessed at weeks 0, 5, 12 and 24)
- PROMs using subjective scales (Likert 0-5) to questions(Assessed at weeks 0, 5, 12 and 24)
- Streamlined Wolf-motor function test (SWMFT)(Assessed at weeks 0, 5, 12 and 24)
- Aggregated number(Assessed at weeks 0, 5, 12 and 24)
- Action Research Arm Test (ARAT)(Assessed at weeks 0, 5, 12 and 24)