NCT07360613

Brief Summary

The Biomedical Engineering Dept, University of Strathclyde, co-creates rehabilitation technology. In 2023-2024 a clinical study (NCT06787768) was conducted to understand the feasibility of a multi-technology approach to rehabilitation early after stroke. This was successful and leads to the next phase which is to gather preliminary evidence of the effectiveness of this approach by monitoring change in the mobility of patients who receive this intervention compared with usual care which will be gathered through a data linkage project (tracking the outcomes from matched patients from other parts of Scotland who receive usual care).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
26mo left

Started Apr 2026

Typical duration for not_applicable stroke

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Apr 2026Jul 2028

First Submitted

Initial submission to the registry

November 26, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

January 22, 2026

Status Verified

November 1, 2025

Enrollment Period

1.2 years

First QC Date

November 26, 2025

Last Update Submit

January 16, 2026

Conditions

Keywords

RehabilitationTechnologyStroke

Outcome Measures

Primary Outcomes (1)

  • Modified Rivermead Mobility Index (MRMI)

    The Modified Rivermead Mobility Index (MRMI) is a standardized 8-item assessment that evaluates mobility tasks including turning over, balance, transfers, walking, and stair climbing. Scores range from 0 to 40, with higher scores indicating greater mobility. The items include: Turning over Lying to sitting Sitting balance Sitting to standing Standing Transfers Walking indoors Stairs

    Baseline (between consent and start of intervention) and immediately before hospital discharge.

Secondary Outcomes (14)

  • 10-Metre Walk Test (10MWT)

    Baseline (between consent and start of intervention) and immediately before hospital discharge.

  • Five Times Sit-to-Stand Test (FTSTST)

    Baseline (between consent and start of intervention) and immediately before hospital discharge.

  • Berg Balance Scale (BBS)

    Baseline (between consent and start of intervention) and immediately before hospital discharge.

  • Action Research Arm Test (ARAT)

    Baseline (between consent and start of intervention) and immediately before hospital discharge.

  • Grip Strength

    Baseline (between consent and start of intervention) and immediately before hospital discharge.

  • +9 more secondary outcomes

Study Arms (1)

Technology Enriched Rehabilitation

EXPERIMENTAL

The intervention is a rehabilitation programme delivered entirely through technology, including virtual reality (immersed and non-immersed), treadmills, weight suspension and movement resistance, and power assistance equipment located in a gym-like space located on an acute stroke unit. Individual programs are designed and reviewed by a physiotherapist using principles of intensity, feedback, cognitive engagement, and aerobic activity to address the goals identified by the participant and scores from outcome measures at baseline. Supervision is provided by rehabilitation assistants Participants attend according to their tolerance (assessed by clinical team) up to 2 hours per day until discharged home.

Other: Technology Enriched Rehabilitation

Interventions

The intervention is a rehabilitation programme delivered entirely through technology, including virtual reality (immersed and non-immersed), treadmills, weight suspension and movement resistance, and power assistance equipment located in a gym-like space on an acute stroke unit (NHS Lanarkshire). Individual programs are designed and reviewed by a physiotherapist using principles of intensity, feedback, cognitive engagement, and aerobic activity to address the goals identified by the participant and scores from outcome measures at baseline. Attendance at the gym is supervised and assisted by rehabilitation support workers. Participants can attend daily for 2 hours maximum until discharge, according to their tolerance and judgement of the clinical ward team.

Technology Enriched Rehabilitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of new stroke by NHS Lanarkshire physician
  • More than 48 hours since stroke event
  • Deemed medically fit for rehabilitation by medical staff
  • Deemed to require rehabilitation
  • Able to provide informed consent

You may not qualify if:

  • Acutely medically unwell
  • Active cardiac disease, such as unstable angina
  • Active delirium/significant levels of confusion
  • Seizure within past 7 days
  • Individual currently being managed under the Adults with Incapacity Act, unless the responsible medic has noted within the document that the individual has capacity to consent to rehabilitation research
  • Known pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Kerr A, Keogh M, Slachetka M, Grealy M, Rowe P. An Intensive Exercise Program Using a Technology-Enriched Rehabilitation Gym for the Recovery of Function in People With Chronic Stroke: Usability Study. JMIR Rehabil Assist Technol. 2023 Jul 21;10:e46619. doi: 10.2196/46619.

  • Sweeney G, Boyd F, Keogh M, Lyczba P, Forrest E, Rowe P, Barber M, Kerr A. A technology-enriched approach to increasing rehabilitation dose after stroke: Clinical feasibility study. Clin Rehabil. 2025 Jun;39(6):740-749. doi: 10.1177/02692155251333542. Epub 2025 Apr 18.

  • Gittins M, Vail A, Bowen A, Lugo-Palacios D, Paley L, Bray B, Gannon B, Tyson S. Factors influencing the amount of therapy received during inpatient stroke care: an analysis of data from the UK Sentinel Stroke National Audit Programme. Clin Rehabil. 2020 Jul;34(7):981-991. doi: 10.1177/0269215520927454. Epub 2020 Jun 7.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Andrew Kerr

    Strathclyde

    STUDY DIRECTOR
  • Gillian Sweeney, PhD

    NHS Lanarkshire

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Kerr, PhD

CONTACT

Lesley-Anne Rollins, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
No masking is used
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Baselines measures of mobility (Primary: Rivermead Mobility Index) before the intervention. Intervention a rehabilitation programme delivered through technology (VR, Treadmills, hand trainers, power assisted exercise). Measures of Mobility repeated immediately before hospital discharge.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2025

First Posted

January 22, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

July 1, 2028

Last Updated

January 22, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

Data will be posted on the University's Data Sharing repository (PURE)

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
July 2027 Until July 2032
Access Criteria
This will be publicly available
More information