Stroke Circulatory System Stroke, not specified as haemorrhage or infarction
Conditions
Interventions
Following baseline assessments participants will be randomly allocated to the intervention or usual care group in a 2:1 ratio. An individual independent of the study will generate a sequence using per
Sponsors
Brunel University London
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Stroke survivors: 1. Aged 18 years or over 2. Clinically confirmed acute stroke with new unilateral weakness 3. Able to provide consent to take part in the study and to comply with the requirements of the protocol 4. Motricity Index score between 9-25 for elbow (from 90 flexion) and/or shoulder movement (shoulder abduction) 5. Ability to communicate in English, sufficient for completion of the trial intervention and assessment 6. Able to see the graphics and visual display on the screen Members of the healthcare team (stroke unit or early stroke supported discharge team): 1. Aged 18 years and over 2. Participated in the delivery of the intervention 3. Provided informed consent
Exclusion criteria
Exclusion criteria: Stroke survivors: 1. Unstable medical conditions 2. Unable to follow a two-stage command 3. Uncontrolled photosensitive epilepsy 4. Shoulder/arm pain exacerbated on movement 5. Already participating in an upper limb rehabilitation trial 6. Patients with significant cognitive impairment and unable to comprehend and follow all instructions relating to participation in the study 7. Care home residents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In accordance with a feasibility RCT this study will test the following outcomes: 1. Outcomes relating to safety (measured at baseline and post 7-week intervention): 1.1. Fatigue measured by the Fatigue Severity Score -7 (FSS-7) 1.2. Pain measured with a 10 point Visual Analogue Scale (VAS) 1.3. Spasticity measured with the Modified Modified Ashworth Scale (MMAS) 2. Outcomes relating to feasibility and acceptability (measured through the study): 2.1. Feasibility of delivery of the intervention will be measured by recording the number of people who receive the training sessions, number of sessions received, the length and content of the training, and the number of clinical or technical phone calls and hospital/home visits required. 2.2. Fidelity to the use of the NeuroBall intervention will be objectively measured throughout the study by using the data collected via the sensors in the device and software on the tablet computer on time spent actively exercising in each game and the number of movement repetitions. 2.3. Fidelity to delivery of the intervention will be measured by recording attendance at training sessions, the number of requests for clinical or technical assistance from the research or technical team. 2.4. Acceptability: 2.4.1. Stroke survivor acceptability of the intervention, including factors that may impact adoption of technology will be assessed post intervention with through semi-structured interviews (n=12) and the Quest 2.0 (n=24) 2.4.2. Healthcare staff acceptability of the intervention (n=9), including factors that may impact adoption of technology, will be assessed through semi-structured interviews 2.4.3. Stroke survivor (n=4) acceptability of allocation to the control group will be assessed through semi-structured interviews | — |
Secondary
| Measure | Time frame |
|---|---|
| 3. Feasibility of a definitive trial determined by measuring: 3.1. Recruitment and retention rates at the completion of the intervention phase 3.2. Outcome measure completion at baseline and post 7-week intervention (and reasons for missing data): 3.2.1. Arm Impairment measured using the Fugl-Meyer Upper-limb (FMA-UL) 3.2.2. Arm function measured using the Action Research Arm Test (ARAT) 3.2.3. Arm function self-report measured using the Motor Activity Log 14 (MAL-14) 3.2.4. Passive range of movement measured using a goniometer (PROM) 3.2.5. Self-efficacy for exercise measured using the Self-efficacy for home exercise programme questionnaire (SHEAPs) 3.2.6. Quality of life measured using the EuroQol 5 Dimensions 5 levels (EQ-5D-5L) 3.2.7. Participation measured using the Subjective Index of Physical and Social Outcome (SIPSO) 3.2.8. Gross level of disability measured using the simplified modified Rankin Scale questionnaire (smRSq) 3.2.9. Health Service Use measured using the adapted Client Service Receipt Inventories (adapted CSRI) 3.2.10. Depression and Anxiety measured using the combined General Anxiety Disorder (GAD-2) and Patient Health Questionnaire (PHQ-2) | — |
Countries
England, United Kingdom
Contacts
Public ContactCherry Kilbride
Outcome results
None listed