The Mechatronic Remote Physiotherapy System (MRPS) in Remote Stroke Rehabilitation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Technology, Sligo
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Mechatronic Remote Physiotherapy System (MRPS)
DeviceThe 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. A sensory substitution balance apparatus and motion detecting sensors are also being designed to connect to the system to allow for lower limb rehabilitation.
Early Supported Discharge
Other interventionESD is a multidisciplinary service providing medically stable patients continued therapy and healthcare in the community.
Treatment groups
14 Participants
are divided into 2 treatment groupsGroup A: ExperimentalExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Protocol Adherence/Compliance Rate.
Percentage of scheduled procedures, visits, or assessments completed as planned. 95% adherence/compliance rate suggest strong adherence/compliance rate.
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
Berg Balance Scale (BBS).
Outcome measure to assess static and dynamic balance with high validity and reliability within the stroke population. The Berg Balance Scale (BBS) is a clinical tool used to assess a person's balance through a series of 14 functional tasks, each scored on a scale from 0 to 4, with a maximum total score of 56. An increase in total BBS score from baseline indicates improved balance. A change of 6-7 points is often considered the minimal detectable change (MDC) in older adults or people with balance issues (i.e., change likely reflects a real improvement, not measurement error).
Time frame
through study completion, an average of 1 year2
Fugl Meyer Assessment (FMA).
Stroke-specific, performance-based impairment index outcome measure. The Fugl-Meyer Assessment (FMA) is a widely used, validated tool to evaluate motor function, balance, sensation, and joint performance in individuals after a stroke. It is particularly focused on motor recovery and is considered one of the most comprehensive quantitative measures of physical impairment post-stroke. The full Fugl-Meyer Assessment includes 5 domains, with a total possible score of 226 points. Higher scores indicate better motor recovery/function. Change in score over time reflects improvement or decline. In stroke rehabilitation:10-point increase in motor score is typically considered clinically meaningful. Smaller changes (e.g., 5-7 points) may still be relevant depending on the baseline and context.
Time frame
through study completion, an average of 1 yearLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Institute of Technology, Sligo
Lead sponsor
Sligo General Hospital
Collaborator
Source ClinicalTrials.gov
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