StrokeNCT05875792
EvolvRehab for Telerehabilitation
A study testing EvolvRehab - MoveWell in people with Stroke, run by University of Exeter at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- EvolvRehab - MoveWell
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Jun 2023to 4 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EvolvRehab - MoveWell Virtual Platform for Stroke Survivors Rapid Rehabilitation Through Fun Exergaming-based Learning
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- EvolvRehab - MoveWell
- Keywords
- telerehabilitation, rehabilitation, stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvolvRehab - MoveWellDevice
The Intervention has been developed and has a CE mark and has medical device level 1 approvals in the UK. It will be developed with patients in Phase 1 and will consist of initial staff training [training package]. Exercise prescription will be encouraged, in line with usual care, for the either one week (stage 1, phase 2) or six weeks (stage 2, phase 2). Individuals will be able to continue using the EvolvRehab - MoveWell system beyond 6 weeks from stage 2, phase 2, and technical support will continue until the end of the study completion, participants will not be limited in the additional activity that can be performed during this time, and encouraged to do as much as they wish, except if needed for clinical reasons. The intervention will be supported by the clinical team in keeping with routine care. The research therapist will attend clinical visits and support as required. The number of visits will be recorded, and will hopefully reduce to zero over the study.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | people who have recently had a stroke and need upper limb rehabilitation Receives: Device: EvolvRehab - MoveWell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl Meyer Assessment
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. The scale is comprised of five domains and there are 155 items in total:
Movements are scored between 0 (none), 1 (partial) or 2 (full/ can be elicited) for reflex activity, volitional movement within synergies, volitional movement mixing synergies, volitional movement with little or no synergy, for upper body including wrist and hand.
Normal reflex activity is scored 0 (hyper), 1 (lively) or 2 (normal).
Co-ordination is scored 0 (marked), 1 (slight) or 2 (none).
Sensation is scored 0 (anesthesia), 1 (hypoesthesia or dysesthesia), 2 (normal)
Joint motion is scored 0 (only few degrees), 1 (decreased), 2 (normal)
Joint pain is scored 0 (pronounced pain), 1 (some pain), 2 (no pain)
Measured: 6 weeks
Secondary outcomes (14)
Carer Strain Index (CSI)
The CSI can be used to quickly identify families with potential caregiving concerns. It is a 13-question tool that measures strain related to care provision. There is at least one item for each of the following major domains: Employment, Financial, Physical, Social and Time. Positive responses to 7 or more items on the index indicate a greater level of strain. This instrument can be used to assess individuals of any age who have assumed the role of carer for an older adult
Measured: 6 weeks
Grip strength
Hand-grip strength was assessed through the use of a handheld dynamometer. Participants sat with the elbow of the arm which was holding the dynamometer, against the side of their body, and bent to a 90˚ angle. Hand-grip strength was measured three times on each side, with the highest value taken as their maximum grip strength.
Measured: 6 weeks
European Quality of Life questionnaire (Eq-5D-5L)
The measure covers five dimensions of health related quality of life: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, scored by level of severity for each dimension (1= no problems, 2= slight problems,3=moderate problems, 4=severe problems, and 5=extreme problems). Overall health status is also measured using a visual analogue score out of 100 whereby higher scores = better quality of life.
Measured: 6 weeks
The World Health Organization Disability Assessment Schedule (WHODAS)
The World Health Organization Disability Assessment Schedule is a generic assessment instrument developed by WHO to provide a standardised method for measuring health and disability across cultures.
Measured: 6 weeks
Health resource use questionnaire
Self-reported questionnaires of healthcare resource utilisation.
Measured: 6 weeks
Acceptability
Questions around: Acceptability of Intervention Measure, Intervention Appropriateness Measure, Feasibility of Intervention Measure.
Response Scale: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree
Measured: 6 weeks
Incidence of adverse events
monitoring of any adverse events
Measured: 6 weeks
System Usability Scale
The SUS is a 10 item questionnaire about how easy the rehabkit is to use, with 5 response options (ranging from strongly disagree = 1 to strongly agree 5).
Measured: 6 weeks
Free-living activity
Participants will use bilateral physical activity monitors (accelerometers), which they will wear for up to 8 days prior to the start of the 6-week intervention, to measure a period of "free-living" at baseline and follow-up. This will objectively measure participants' habitual physical activity level. Participants will be asked to continuously wear the monitors for 24 hours a day for up to 8 days.
The devices will be initialised using the manufactures software under default settings. Alongside this, participants will also be asked to fill out a self-report diary (wake and sleep log) for the days they wear the devices, and if completely necessary, record any time when the devices are removed.
Measured: 6 weeks
Process interviews
Interviews will be led by researchers from UoE. (Interviews with clinicians, participants and carers post-trial will explore potential improvements and user experience, including testimonials for dissemination
Measured: 6 weeks
Shoulder Abduction Finger extension
The SAFE score is calculated by scoring Shoulder Abduction and Finger Extension of the paretic upper limb using the Medical Research Council grades.
The patient's strength in each of these movements is scored between 0 and 5. 0 = no palpable muscle activity
- = palpable muscle activity, but no movement
- = limited active range of motion without gravity
- = full active range of motion against gravity, but no resistance
- = full active range of motion against gravity and resistance, but weaker than the other side
- = normal power
Measured: 6 weeks
Movement quality in "movewell" activities on the EvolvRehab system
Number of compensatory movements identified automatically by the EvolvRehab system during prescribed rehabilitation exercises
Measured: 6 weeks
Movement quantity in "movewell" activities on the EvolvRehab system
Measure of how many repetitions of exercises identified automatically by the EvolvRehab system during prescribed rehabilitation exercises
Measured: 6 weeks
Range of motion
Measure of ranges of motion in shoulder flexion, should abduction, elbow flexion (completed on the EvolvRehab system)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start14 Jun 2023
- Primary completion4 May 2024
- Study completion4 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, before and after feasability study
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05875792
- Sponsor's protocol ID
- SBRIH18P2018
- Status last verified
- Aug 2024
- First submitted
- 22 Feb 2023
- Last updated
- 7 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Perks J, McBride P, Mansoubi M, Clatworthy P, Hulme C, Taylor G, Warner M, Dawes H. EvolvRehab-MoveWell telerehabilitation for stroke survivors: study protocol for a feasibility with embedded initial proof-of-concept study. BMJ Open. 2024 May 6;14(5):e078104. doi: 10.1136/bmjopen-2023-078104.
PubMed 38719328
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EvolvRehab - MoveWell Virtual Platform for Stroke Survivors Rapid Rehabilitation Through Fun Exergaming-based Learning
- ClinicalTrials.gov ID
- NCT05875792
- Acronym / sponsor ID
- SBRIH18P2018
- Conditions
- Stroke
- Keywords
- telerehabilitation, rehabilitation, stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- 4 May 2024 (actual)
- Study completion
- 4 May 2024 (actual)
- First posted
- 25 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, before and after feasability study
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: EvolvRehab - MoveWellpeople who have recently had a stroke and need upper limb rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EvolvRehab - MoveWellThe Intervention has been developed and has a CE mark and has medical device level 1 approvals in the UK. It will be developed with patients in Phase 1 and will consist of initial staff training [training package]. Exercise prescription will be encouraged, in line with usual care, for the either one week (stage 1, phase 2) or six weeks (stage 2, phase 2). Individuals will be able to continue using the EvolvRehab - MoveWell system beyond 6 weeks from stage 2, phase 2, and technical support will continue until the end of the study completion, participants will not be limited in the additional activity that can be performed during this time, and encouraged to do as much as they wish, except if needed for clinical reasons. The intervention will be supported by the clinical team in keeping with routine care. The research therapist will attend clinical visits and support as required. The number of visits will be recorded, and will hopefully reduce to zero over the study. | Device | Intervention |
Primary outcome
Fugl Meyer Assessment
Time frame: 6 weeks
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. The scale is comprised of five domains and there are 155 items in total: Movements are scored between 0 (none), 1 (partial) or 2 (full/ can be elicited) for reflex activity, volitional movement within synergies, volitional movement mixing synergies, volitional movement with little or no synergy, for upper body including wrist and hand. Normal reflex activity is scored 0 (hyper), 1 (lively) or 2 (normal). Co-ordination is scored 0 (marked), 1 (slight) or 2 (none). Sensation is scored 0 (anesthesia), 1 (hypoesthesia or dysesthesia), 2 (normal) Joint motion is scored 0 (only few degrees), 1 (decreased), 2 (normal) Joint pain is scored 0 (pronounced pain), 1 (some pain), 2 (no pain)
14 secondary outcomes
Carer Strain Index (CSI)
Time frame: 6 weeks
Grip strength
Time frame: 6 weeks
European Quality of Life questionnaire (Eq-5D-5L)
Time frame: 6 weeks
The World Health Organization Disability Assessment Schedule (WHODAS)
Time frame: 6 weeks
Health resource use questionnaire
Time frame: 6 weeks
Acceptability
Time frame: 6 weeks
Incidence of adverse events
Time frame: 6 weeks
System Usability Scale
Time frame: 6 weeks
Free-living activity
Time frame: 6 weeks
Process interviews
Time frame: 6 weeks
Shoulder Abduction Finger extension
Time frame: 6 weeks
Movement quality in "movewell" activities on the EvolvRehab system
Time frame: 6 weeks
Movement quantity in "movewell" activities on the EvolvRehab system
Time frame: 6 weeks
Range of motion
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Derived from this study: PubMed 38719328Perks J, McBride P, Mansoubi M, Clatworthy P, Hulme C, Taylor G, Warner M, Dawes H. EvolvRehab-MoveWell telerehabilitation for stroke survivors: study protocol for a feasibility with embedded initial proof-of-concept study. BMJ Open. 2024 May 6;14(5):e078104. doi: 10.1136/bmjopen-2023-078104.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EvolvRehab - MoveWell in people with Stroke, run by University of Exeter at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl Meyer Assessment (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05875792, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.