Stroke Clinical Trial
Official title:
EvolvRehab - MoveWell Virtual Platform for Stroke Survivors Rapid Rehabilitation Through Fun Exergaming-based Learning
NCT number | NCT05875792 |
Other study ID # | SBRIH18P2018 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 14, 2023 |
Est. completion date | May 4, 2024 |
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | May 4, 2024 |
Est. primary completion date | May 4, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Devon and Exeter Hospitals | Exeter |
Lead Sponsor | Collaborator |
---|---|
University of Exeter |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) |
6 weeks | |
Secondary | 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 | 6 weeks | |
Secondary | 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. | 6 weeks | |
Secondary | 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. | 6 weeks | |
Secondary | 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. | 6 weeks | |
Secondary | Health resource use questionnaire | Self-reported questionnaires of healthcare resource utilisation. | 6 weeks | |
Secondary | 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 |
6 weeks | |
Secondary | Incidence of adverse events | monitoring of any adverse events | 6 weeks | |
Secondary | 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). | 6 weeks | |
Secondary | 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. |
6 weeks | |
Secondary | 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 | 6 weeks | |
Secondary | 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 |
6 weeks | |
Secondary | Movement quality in "movewell" activities on the EvolvRehab system | Number of compensatory movements identified automatically by the EvolvRehab system during prescribed rehabilitation exercises | 6 weeks | |
Secondary | 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 | 6 weeks | |
Secondary | Range of motion | Measure of ranges of motion in shoulder flexion, should abduction, elbow flexion (completed on the EvolvRehab system) | 6 weeks |
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