Home RehabGym: a Qualitative and Usability Evaluation of Advanced Technologies for Home Upper Limb Neurorehabilitation Post-stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Compliance Rates
研究概览
简要总结
Due to limited resources such as the low therapist to patient ratio or high costs associated to rehabilitation therapy, providing higher therapy dose to patients after discharge is highly challenging. This often results in non-use of the impaired limb as a result of the decreased therapy dose, causing partial loss of the functional improvements previously gained during early rehabilitation.
In this study, the investigators plan to pilot the HomeRehab Gym concept via the deployment of three rehabilitation devices at patients' homes: MyoPanda, H-Man and ReHandyBot.
详细描述
Previous research has proven that technology-aided upper limb rehabilitation is non-inferior in terms of feasibility and efficacy when compared to conventional therapy in stroke patients. These rehabilitation devices can be set up as a 'rehabilitation gym' (RehabGym), where patients can interact with several devices that target different body and rehabilitation domains and, thus allows for a holistic and complementary therapy.
Despite recent studies having shown that training with a RehabGym under reduced supervision in a hospital is not only feasible but also equally beneficial in terms of clinical outcomes, however, a RehabGym has never been set up at a patient's home to the best of our knowledge.
This study aims to investigate the feasibility and safety of a RehabGym at home concept using three different upper-limb technologies (H-Man, ReHandyBot, MyoPanda) that are established, clinically tested and allow for on-demand therapy. Objective measures of clinical efficacy will also be examined, and cost-analysis to determine the economic feasibility of a commercial implementation of RehabGym at home in the future will be performed.
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
- •Clinical stroke (ischaemic or haemorrhagic) confirmed by admitting doctors and CT, CT angiography or MRI brain imaging
- •Age 21 to 80 years, both males and females
- •At least 28 days post-stroke
- •Upper limb motor impairment of Fugl-Meyer Assessment (FMA) scale 20 to 50
- •Montreal Cognitive Assessment (MoCA) > 21/30
- •Ability to sit supported and continuously for 60 minutes
- •Stable home abode with enough space to place technologies
- •Has a carer/next of kin to supervise home-based exercises
排除标准
- •Functional impairment of the upper limb due to other pathologies
- •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 less than 6 months
- •Pacemakers and other active implants
- •Active seizures within 3 months
- •Local factors potentially worsened by intensive technology-aided upper-limb therapy and computer-based training:
- •Spasticity - modified Ashworth Scale MAS > 2 of any upper limb muscle groups
- •Severe pain in affected arm - Visual Analogue Scale for pain VAS > 5/10
- •Skin wounds
- •Cognitive impairment precluding study participation
- •Severe visual impairment or visual neglect affecting ability to use technologies
- •History of dementia, depression or behavioural problems
- •Pregnant or lactating females will not be allowed to participate
研究组 & 干预措施
Home Robotics Upper Limb Training
The patients will first familiarize in the clinic with the 3 devices (H-MAN, ReHandyBot and MyoPanda) with initial assistance of the therapists and then take the devices home for independent, self-administered training under caregiver supervision.
During the 6 weeks training (home phase), patients will be provided with two devices at any one time: with only the MyoPanda being used by the patient for 6 weeks. The H-MAN and ReHandyBot will stay with the patient for 3 weeks (i.e., 21 days) each.
干预措施: H-Man Robot (Device)
Home Robotics Upper Limb Training
The patients will first familiarize in the clinic with the 3 devices (H-MAN, ReHandyBot and MyoPanda) with initial assistance of the therapists and then take the devices home for independent, self-administered training under caregiver supervision.
During the 6 weeks training (home phase), patients will be provided with two devices at any one time: with only the MyoPanda being used by the patient for 6 weeks. The H-MAN and ReHandyBot will stay with the patient for 3 weeks (i.e., 21 days) each.
干预措施: ReHandyBot (Device)
Home Robotics Upper Limb Training
The patients will first familiarize in the clinic with the 3 devices (H-MAN, ReHandyBot and MyoPanda) with initial assistance of the therapists and then take the devices home for independent, self-administered training under caregiver supervision.
During the 6 weeks training (home phase), patients will be provided with two devices at any one time: with only the MyoPanda being used by the patient for 6 weeks. The H-MAN and ReHandyBot will stay with the patient for 3 weeks (i.e., 21 days) each.
干预措施: MyoPanda (Device)
结局指标
主要结局
Compliance Rates
时间窗: Through study's data collection period, up to 2 years.
Using cloud data from vendor, time (min/hours) of robot (H-Man, ReHandyBot, MyoPanda) usage
次要结局
- Action Research Arm Test (ARAT)(Weeks 0 (baseline), 3 (mid-intervention assessment), 6 (post-intervention assessment), 12 (1st follow-up assessment), 24 (last follow-up assessment))
- System Usability Scale (SUS)(Weeks 3 (mid-intervention assessment), 6 (post-intervention assessment)))
- Fugl Meyer Motor Assessment (FMA)(Weeks 0 (baseline), 3 (mid-intervention assessment), 6 (post-intervention assessment), 12 (1st follow-up assessment), 24 (last follow-up assessment))
- Hr-QOL scales using SS-QOL (Stroke specific Quality of Life scale)(Weeks 0 (baseline), 6 (post-intervention assessment), 12 (1st follow-up assessment), 24 (last follow-up assessment))
- Box and Block Test (BBT)(Weeks 0 (baseline), 3 (mid-intervention assessment), 6 (post-intervention assessment), 12 (1st follow-up assessment), 24 (last follow-up assessment))