NCT06928285

Brief Summary

The minimum guideline recommendations for rehabilitation after stroke are not being met. This compromises individual recovery and increasing the global burden of disability. A multi-technology solution, co-created with people living with stroke, has been shown to be feasible in both sub-acute and chronic populations but has not been implemented as an integrated rehabilitation service. The aim of this implementation study is to assess the ability of a technology enriched model of rehabilitation to deliver guideline recommendations in a range of NHS and local authority settings that provide rehabilitation services to stroke survivors at different stages of their recovery. The findings will be used to co-create a scalable, adaptable, and sustainable model that meets rehabilitation guidelines.

Trial Health

65
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Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for not_applicable stroke

Timeline
22mo left

Started Aug 2025

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

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Study Timeline

Key milestones and dates

Study Progress30%
Aug 2025Mar 2028

First Submitted

Initial submission to the registry

April 7, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 15, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

April 15, 2025

Status Verified

March 1, 2025

Enrollment Period

2 years

First QC Date

April 7, 2025

Last Update Submit

April 7, 2025

Conditions

Keywords

rehabilitationtechnologyimplementation

Outcome Measures

Primary Outcomes (2)

  • 10-meter walk test (10mWT)

    Time to walk 10 metres

    Three time points; 1) Two weeks before intervention starts at the initial induction meeting,2) immediately before the intervention, and 4) immediately after intervention ends

  • Five times sit to stand movement

    Time to complete five sit to stand movements safely.

    Three time points; 1) Two weeks before intervention starts, at the induction meeting,2) immediately before the intervention and 3) immediately after intervention ends

Secondary Outcomes (2)

  • Stroke Impact Scale

    Two time points; 1) Two weeks before intervention starts and 2) immediately after intervention ends

  • Action Research Arm Test (ARAT)

    Two time points; 1) Two weeks before intervention starts and 2) immediately after intervention ends

Other Outcomes (1)

  • Communication Outcome after Stroke (COAST) scale

    Two time points; 1) Two weeks before intervention starts and 2) immediately after intervention ends

Study Arms (1)

Technology enriched rehabilitation: Intervention

EXPERIMENTAL

People well enough to exercise lightly but living with motor impairment following a stroke will attend a personalised circuit based programme in a technology enriched rehabilitation gym with exercise and activities structured around their motor, communication and cognitive impairments.

Other: Technology Enriched Rehabilitation

Interventions

The intervention is an 8-week long 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 a university campus. Individual programs are designed, supervised, 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. Participants should attend a minimum of two times per week and can more frequently for the two hour group based circuit class.

Technology enriched rehabilitation: Intervention

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of stroke
  • Currently well
  • Suitable for rehabilitation (motor/ciommunication and or/cognitive impairment(
  • Able to attend the programme for two hours at least twice a week
  • Able to follow instructions in English and follow provide verbal and/or written feedback

You may not qualify if:

  • Absolute contradictions to physical activity
  • Recent (6 weeks) deterioration in health
  • Change in medication
  • Currently unwell

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Andrew B Kerr, PhD

    University of Strathclyde

    STUDY DIRECTOR

Central Study Contacts

Andrew B Kerr, PhD

CONTACT

Milena Sklachetka Research Physiotherapist, M.Sc.

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: Implementation study assessing; 1. ability to sustainably deliver NICE (National Institute for Clinical Effectiveness, UK) recommendations for rehabilitation after stroke (intensity and dose) 2. Response from participants including changes to mobility, communication and impact on life. This will include a data linkage control group with dat aopn health and care use
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2025

First Posted

April 15, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

April 15, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

We will share the outcomes of the implementation study including interview transcipts and outcome measures

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
August 2027 for 5 years
Access Criteria
This will be publicly available from the University of Strathclyde repository (PURE)
More information