Clinical trial NCT06928285: Community Rollout of Technology Enriched Rehabilitation After Stroke: An Implementation Study
Official title: Community Rollout of Technology Enriched Rehabilitation After Stroke: An Implementation Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Keywords: rehabilitation
technology
implementation
Lead sponsor: University of Strathclyde
Sponsor class: OTHER
Collaborators: name: NHS Lothian
name: NHS Lanarkshire
name: Dundee Leisure and Culture
First posted: 2025-04-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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
Primary purpose: TREATMENT

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.

Detailed description: A recently completed pilot study (NCT05981729) demonstrated the feasibility of our multi-technology circuit based model of rehabilitation in an acute NHS stroke unit (UHW, NHS Lanarkshire). The key findings were that the model delivered an average of 52 minutes of additional rehabilitation every day, without any safety concerns and with supervision provided by rehabilitation assistants. Importantly for future implementation the participating patients and ward staff were all very positive about the novel approach. The challenge now is to translate these positive findings into a sustainable national solution that maintains fidelity to the key parameters of evidence-based rehabilitation (personalised, high intensity, and enriched environment) and can be adopted by diverse service providers (NHS, Local Authority, and medical charities) across various settings, to support people through their whole recovery journey.

Aim To develop an acceptable and sustainable implementation model of technology enriched rehabilitation after stroke that sustainably delivers NICE (National Institute for Clinical Effectiveness) guideline recommendations in a range of rehabilitation settings and phases of recovery after stroke.

Design This is an implementation study using a mixed methods approach to assess technology enriched rehabilitation gyms across a network of NHS, local authority and 3rd sector funded rehabilitation services. Part of the implementation study will involve gathering preliminary evidence of efficacy through comparison with a control group matched for age and stroke through a data linkage project (eDRIS, Data Scotland).

Locations Four locations have agreed to participate, they represent different stages of recovery after stroke, from acute illness (University Hospital Wishaw, Wishaw, UK) to community care (Blantyre Life, Blantyre, UK) and Edinburgh Community Stroke Service, Edinburgh, UK) and long-term maintenance (Olympia leisure centre, Dundee, UK). At one location (Edinburgh) the study will also test whether a higher dose of rehabilitation can be delivered within current resources including participant tolerance and what resources are required to maintain a high dose delivery.

Participants All participants will have a diagnosis of stroke (physician diagnosed) and be suitable for rehabilitation. Specific eligibility criteria, such as time since stroke, will vary across the locations and are detailed later.

Intervention This will be delivered by the local teams of suitably qualified (e.g. physiotherapists) staff following training from the Strathclyde team.

Intervention parameters Frequency: at least twice a week Intensity: Always sub-maximal. Determined by the amount of time spent in each activity and (where possible) the number of movements (e.g. steps on treadmill) performed Time: 2 hours max with activities varied between seated and standing Total duration: 8 weeks

Content

The TERG intervention has been described in general terms in recent publications (Kerr, Grealy et al. 2021, Kerr, Keogh et al. 2023) and is detailed in a comprehensive manual which will be used for training and to improve fidelity. The key elements are described below:

Once consent has been taken and outcome measures have been recorded each participant should be supported in setting three personal goals. Some training will be provided around effective goal setting. These, together with the initial outcome measures, will be used to structure an initial training programme that will be reviewed regularly (every 2 weeks). The programme will only use the technology listed below and individuals should be trained (as much as possible) to use the equipment on their own, with physical assistance and support provided by the supervising staff.

Rehabilitation equipment and purpose:

1. Treadmill with adjustable walking harness system. Purpose: Gait and balance training
2. Large, height adjustable, computer tablet with digital health apps. Purpose: Communication and cognitive training performed in standing or sitting
3. GripAble hand trainer. Purpose: Upper limb training and cognitive training
4. Mirror Therapy. Purpose: Motor priming \& upper limb training
5. Power assisted Seated rower. Purpose: General exercise, aerobic, strength, flexibility
6. Power assisted Cross cycle trainer. Purpose: General exercise, aerobic, strength, flexibility
7. Power assisted Seated climber. Purpose: General exercise, aerobic, strength, flexibility
8. Power assisted bike: Purpose: General exercise, aerobic, strength, flexibility
9. VR headset; Purpose: Upper limb and balance upper limb co-ordination and balance

On completion of the 8 week programme outcome measures will be repeated and participants will be interviewed by a researcher not involved in the programme delivery to understand the user experience.

Data collected

1. Participant attendance (number sessions attended) and engagement (movements performed) with activities.
2. Incidence of safety events (adverse events)
3. Interviews with staff and participants
4. Delivery costs (staff and equipment)
5. Standard measures of mobility (10 mwt, five times sit to stand), communication and patient reported outcomes on function (Rivermead Mobility Index) and quality of life (Stroke Impact Scale). These will be recorded before the programme begins and immediately after completion.
6. Health and Care costs for 6 months after intervention through a data linkage project

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: 10-meter walk test (10mWT)
timeFrame: 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
measure: Five times sit to stand movement
timeFrame: 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:
measure: Stroke Impact Scale
timeFrame: Two time points; 1) Two weeks before intervention starts and 2) immediately after intervention ends
measure: Action Research Arm Test (ARAT)
timeFrame: Two time points; 1) Two weeks before intervention starts and 2) immediately after intervention ends
Other outcomes:
measure: Communication Outcome after Stroke (COAST) scale
timeFrame: Two time points; 1) Two weeks before intervention starts and 2) immediately after intervention ends
Locations:
Study officials:
affiliation: University of Strathclyde
name: Andrew B Kerr, PhD
role: STUDY_DIRECTOR
References: