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NCT Number: NCT06964789

The Mechatronic Remote Physiotherapy System (MRPS) in Remote Stroke Rehabilitation

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Neurological Disorder Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mechatronic Remote Physiotherapy System (MRPS)

Device

The 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.

Other names: MRPS

Early Supported Discharge

Other

ESD is a multidisciplinary service providing medically stable patients continued therapy and healthcare in the community.

Other names: ESD

Primary outcomes

  1. Protocol Adherence/Compliance Rate.

    Time frame: 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.

Secondary outcomes

  1. Berg Balance Scale (BBS).

    Time frame: through study completion, an average of 1 year

    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).

  2. Fugl Meyer Assessment (FMA).

    Time frame: through study completion, an average of 1 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kenneth Monaghan, PhD

CONTACT

[email protected]

0879480448

Peter Lynch, PhD

CONTACT

[email protected]

0879480448

Sponsors and collaborators

Lead sponsor

Institute of Technology, Sligo

Other

Collaborators

  • Sligo General Hospital

Registry information

Official study title

The Mechatronic Remote Physiotherapy System (MRPS) in Remote Stroke Rehabilitation: A Pilot Controlled Trial for 'Early Supported Discharge'

Acronym: MRPS

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 9, 2025
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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