The Mechatronic Remote Physiotherapy System (MRPS) in Remote Stroke Rehabilitation: A Pilot Controlled Trial for 'Early Supported Discharge'
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 14
- 主要终点
- Protocol Adherence/Compliance Rate.
研究概览
简要总结
The aim of this pilot trial is to examine and compare the safety and feasibility of enhanced Early Supported Discharge (ESD) through the Mechatronic Remote Physiotherapy System (MRPS) and traditional ESD after stroke.
The main questions this trial aims to answer are:
- Is enhanced ESD via the MRPS safe, feasible and significantly different compared to traditional ESD when administered to patients after stroke?
- Do patients interact with and are they satisfied with the MRPS?
- Is enhanced ESD cost-effective compared to traditional ESD?
- Are there any adverse effects of the MRPS and what are the areas for further improvement?
Participants in the experimental group will receive enhanced ESD through the MRPS.
The intervention will be given for approximately 6-8 weeks in total. Frequency will be determined by how often the participants' use the MRPS themselves. Frequency of use and level of completion of each session will be monitored. Enhanced ESD therapy sessions will be designed to reflect traditional ESD sessions.
Participants in the control group will receive traditional ESD. The intervention will be given for approximately 6-8 weeks in total with a frequency of 1-3 therapy visits per week (as per traditional ESD). Therapy sessions will be designed by therapists delivering the ESD service.
详细描述
The Mechatronic Remote Physiotherapy System (MRPS) is an Online Rehabilitation Platform for neurology patients. The platform has been designed to provide supervised and monitored remote rehabilitation therapy, initially focusing on patients who have suffered a stroke. The system comprises of a patent pending mirror therapy strengthening device, which is a neural therapy device using mirror therapy and exercise apparatus for upper limb rehabilitation. The platform also permits the addition of modules beneficial to the patients' recovery. The use of a sensory substitution balance apparatus and motion capturing sensors are also being developed to allow for lower limb rehabilitation.
Participants will be randomly allocated to an experimental (n=7) or control group (n=7) using a block stratified randomization process. Block randomization will be stratified for age, gender and degree of disability (computer-generated random numbers) with allocation concealment.
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)
盲法说明
Single blinded/masked design. As participants will be receiving either remote enhanced ESD or traditional therapist present ESD, blinding/masking of participants is not possible as they will be aware of the intervention they receive. Outcome measure assessors will be blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical diagnosis of stroke;
- •Completed inpatient rehabilitation;
- •A level of ability that would allow them to participate safely (as determined by ESD team);
- •Cognitive ability to consent and take part;
- •Technological ability and resources to allow them to access MRPS platform;
- •A proficiency in the English Language.
排除标准
- •Involvement in other studies or rehabilitation programmes;
- •A level of disability that would prevent them from participating safely (as determined by ESD team);
- •Low level technological literacy or resources (e.g. Wi-Fi) which would prevent access to MRPS platform;
- •Have uncontrolled medical condition or another serious medication condition in addition to stroke;
- •Unable to understand or follow directions.
结局指标
主要结局
Protocol Adherence/Compliance Rate.
时间窗: through study completion, an average of 1 year
Percentage of scheduled procedures, visits, or assessments completed as planned. 95% adherence/compliance rate suggest strong adherence/compliance rate.
次要结局
- Berg Balance Scale (BBS).(through study completion, an average of 1 year)
- Fugl Meyer Assessment (FMA).(through study completion, an average of 1 year)
研究者
Kenneth Monaghan
Director Kenneth Monaghan
Institute of Technology, Sligo