Clinical trial NCT06964789: The Mechatronic Remote Physiotherapy System (MRPS) in Remote Stroke Rehabilitation
Official title: The Mechatronic Remote Physiotherapy System (MRPS) in Remote Stroke Rehabilitation: A Pilot Controlled Trial for 'Early Supported Discharge'
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Neurological Disorder
Keywords: Remote rehabilitation
Neurorehabilitation
Upper limb
Lower limb
Early Supported Discharge
Lead sponsor: Institute of Technology, Sligo
Sponsor class: OTHER
Collaborators: name: Sligo General Hospital
First posted: 2025-05-09
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot randomized controlled trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Protocol Adherence/Compliance Rate.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Berg Balance Scale (BBS).
timeFrame: through study completion, an average of 1 year
measure: Fugl Meyer Assessment (FMA).
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
affiliation: ATU Sligo
name: Kenneth Monaghan, PhD
role: STUDY_DIRECTOR
References: