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

NCT06964789 | Not Yet Recruiting

• 1 other identifier: ATU Sligo
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stroke; Neurological Disorder

Keywords

Remote rehabilitation; Neurorehabilitation; Upper limb; Lower limb; Early Supported Discharge

Outcome Measures

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.

  through study completion, an average of 1 year

Secondary Outcomes (2)

• Berg Balance Scale (BBS).

  through study completion, an average of 1 year

• Fugl Meyer Assessment (FMA).

  through study completion, an average of 1 year

Study Arms (2)

Experimental

EXPERIMENTAL

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.

Device: Mechatronic Remote Physiotherapy System (MRPS)

Control

ACTIVE COMPARATOR

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

Other: Early Supported Discharge

Interventions

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.

Also known as: MRPS

Experimental

Early Supported Discharge OTHER

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

Also known as: ESD

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Technology, Sligo: lead
• Sligo General Hospital: collaborator

MeSH Terms

Conditions

Stroke; Nervous System Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kenneth Monaghan, PhD

  ATU Sligo

  STUDY DIRECTOR

Central Study Contacts

Kenneth Monaghan, PhD

CONTACT

0879480448; kenneth.monaghan@atu.ie

Peter Lynch, PhD

CONTACT

0879480448; peter.lynch@atu.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Kenneth Monaghan

Model Details: Pilot randomized controlled trial

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: May 9, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 14, 2025

Record last verified: 2025-05