Clinical trial NCT05875792: EvolvRehab for Telerehabilitation
Official title: EvolvRehab - MoveWell Virtual Platform for Stroke Survivors Rapid Rehabilitation Through Fun Exergaming-based Learning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: telerehabilitation
rehabilitation
stroke
Lead sponsor: University of Exeter
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm, before and after feasability study
Primary purpose: TREATMENT

Brief summary: This study includes two stages to develop the use of EvolvRehab telerehabilitation in the use of Stroke patients, early after stroke. All tasks will be conducted by multiple research sites. Stage 2 will include at least 6 weeks of study intervention, and up to 6 months follow-up, where possible.

Detailed description: All tasks in this phase will be conducted by at least two research sites (University of Exeter (site 1) and University of Bristol (site 2)) and the results from stage 1 of the study will be used to inform stage 2, following an amendment to incorporate any changes required.

Stage 1, phase 1: Review of product and processes for the preliminary pilot. The investigators will adopt a Person-Based Approach (user-Centred Design plus behavioural science) to further co-develop/refine the technology and clinical processes for use in National Health Service (NHS) stroke community services (n=15).

Stage 1, phase 2: Iterative pilot. EvolvRehab/MoveWell will be iteratively piloted in five stroke survivors' homes in one NHS team. The investigators will purposefully recruit a heterogeneous sample (e.g. gender, digital literacy, and home context). For this intervention stage of the pilot, patients will give consent. Participants will use EvolvRehab/MoveWell for one week. The research therapist will visit participants' homes alongside research staff to provide support and monitor home safety. A log of issues and feedback will be compiled. We will collect system data to finalise system refinements.

Stage 1, phase 3: Staff focus group. Rehab team staff (clinicians, carers, managers; n = 5) from Site 1 will be convened to agree how EvolvRehab will be deployed in community stroke services. The investigators will identify barriers and facilitators to deployment and report how these will be addressed. This will be advertised via poster which will be sent via email to stakeholders already involved in the study.

Stage 1, phase 4: Service user interviews. Semi-structured interviews will be held with stroke survivors used in stage 1, phase 2 (n=5) to explore issues experienced in using the system in their homes. The investigators will explore support structures (e.g., social networks) and barriers/ facilitators to engagement. Potential changes to software, hardware, support, and training will be mapped and reported. Patient/carer instruction materials will be created. The investigators will create a Digital Inclusion Package. Patients will be contacted to organise this via telephone and/or email.

Stage 1, phase 5: Service specification. A final service and product specification including reference to materials above, will be prepared to inform the second stage of the study.

All tasks in this phase will be conducted by multiple research sites. Stage 2 will include at least 6 weeks of study intervention, and up to 6 months follow-up, where possible.

Stage 2, phase 1: Site engagement and set-up.

At least two sites have expressed firm interest in participating in this study. Site set-up will start at the earliest opportunity, including staff training. Recruitment sites will be rolling, adding additional sites (with appropriate approvals) until the recruitment target is reached.

Stage 2, phase 2: Recruitment and follow-up n = 70. Participants will be identified by their treatment team. Potential participants will be screened against inclusion/ exclusion criteria and read a participant information sheet before consent will be taken. Participants will be shown how to use the system by their treating therapist and provided with additional support as required by the research therapist which will be recorded.

Stage 2, phase 3: Continuation phase n = 70. For the duration of the study, participants will continue to use EvolvRehab as they wish. Use and progression will be recorded by the system. Patients will continue to be provided with support. Support requirements will be logged.

Stage 2, phase 4: Data collection and management n = 70. Outcome Measures will be recorded by a member of the research team, as follows:

Health economic outcomes: Full data for 50 participants

Feasibility of intervention use in stroke services: Full data for 50 participants (Stroke severity and disability); Impairment (motor assessment); physical function (shoulder abduction finger extension, grip strength, barthel); physical activity; communication impairment; Cognitive impairment; Patient activation; Acceptability (amount of use, process interviews, user satisfaction); Safety (adverse events)

Feasibility of potential future clinical trial (Recruitment and retention rate; data completeness)

Clinical effectiveness (Note that this is a single arm study and will not provide definitive evidence of clinical effectiveness). In addition to clinical effectiveness measures. Feasibility of intervention: time in EvolvRehab activities; number of repetitions; health-related quality of life (EQ-5D-5L); carer strain index. Measures of compensation/quality of movement. Subjective reports of effectiveness.

Service utilisation: Measures of utilisation of resources during the study for the health economic analysis (number and duration of staff visits; requirement for technical support; training required).

Stage 2, phase 5: Process interviews n = 15. Interviews with clinicians, participants, and carers post-trial will explore potential improvements and user experience, including testimonials for dissemination. This will be advertised via poster which will be sent via email to stakeholders already involved in the study.

Stage 2, phase 6: Data analysis

Analyses will be conducted under headings:

Health economics (including service utilisation)

Feasibility of delivery (Recruitment and retention rate; data completeness)

Feasibility of future clinical trial: variability of clinical outcomes will allow estimation of sample size for a future trial of system clinical effectiveness. Recruitment and retention rates will be used to estimate necessary recruitment

Clinical effectiveness: analysis will focus on improvement over the course of the study, particularly compensatory movements and disability

Stage 2, phase 7: Dissemination

Dissemination activities will be carried out according to the Dissemination Plan co-written with stroke survivors. The investigators will use a variety of means to disseminate the results to a range of stakeholders. Methods include academic publications and presentations; written reports; articles in publications of stakeholder organisations; presentations to and publications for potential customers. Stakeholders include stroke survivors and the public; health professionals (individuals and organisations); clinical academics; voluntary sector organisations; health and care commissioners and providers.

Eligibility criteria: Inclusion Criteria:

* Experiencing motor difficulties in using the paretic arm, with some use of hand/arm as determined by clinical treatment team
* Able to safely participate and complete EvolvRehab activities as determined by clinical treatment team
* Male/female ≥18 years old
* Recently had a stroke requiring upper limb intensive rehabilitation
* The participant is expected to be able to use equipment for a minimum of 1 week
* Capacity to consent to participate
* Able to communicate adequately in English with the research team

Exclusion Criteria:

* Participating in another intervention which the research team deem could interfere with study outcomes
* Any medical condition compromising the safety or the ability to take part to the study as determined by the clinical treatment team (such as insufficient vision or hearing, upper limb condition not linked to stroke, uncontrolled blood pressure, uncontrolled diabetes, co-morbidity)
* History of more than one epileptic seizures since stroke onset or uncontrolled epileptic seizure
* Cognitive or communication impairment such that the participant is unable to follow a two stage command
* Moderate to severe hemi-spatial neglect compromising the ability to take part to the study, as determined by research team

Primary outcomes:
measure: Fugl Meyer Assessment
timeFrame: 6 weeks
Secondary outcomes:
measure: Carer Strain Index (CSI)
timeFrame: 6 weeks
measure: Grip strength
timeFrame: 6 weeks
measure: European Quality of Life questionnaire (Eq-5D-5L)
timeFrame: 6 weeks
measure: The World Health Organization Disability Assessment Schedule (WHODAS)
timeFrame: 6 weeks
measure: Health resource use questionnaire
timeFrame: 6 weeks
measure: Acceptability
timeFrame: 6 weeks
measure: Incidence of adverse events
timeFrame: 6 weeks
measure: System Usability Scale
timeFrame: 6 weeks
measure: Free-living activity
timeFrame: 6 weeks
measure: Process interviews
timeFrame: 6 weeks
measure: Shoulder Abduction Finger extension
timeFrame: 6 weeks
measure: Movement quality in "movewell" activities on the EvolvRehab system
timeFrame: 6 weeks
measure: Movement quantity in "movewell" activities on the EvolvRehab system
timeFrame: 6 weeks
measure: Range of motion
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospitals
Study officials:
References: