Stroke Nervous System Diseases Stroke
Conditions
Interventions
Current version as of 17/04/2018:
All participants will be provided with a Gameball, which consists of a specially designed device and software platform for gamification of upper limb rehabilitation a
most of these will be repeated later at the end of the using the device and then again 4 weeks later.
In the first week we will teach the participant how to use the Gameball device independently (or
Sponsors
Brunel University London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Capacity to consent 2. Unilateral stroke 3. Minimum of 12 weeks post-stroke and finished formal rehabilitation for their arm (ie NHS or private provider) 4. Mild to moderately severe reduction in arm function (9-25 on the Motricity Index) 5. Able to sit independently for up to 5 minutes before requiring rest 6. Aged 18 years or older
Exclusion criteria
Exclusion criteria: 1. Photosensitive epilepsy 2. Pain in the arm at rest 3. People with severe visual neglect/hemianopia (score >0 on NIHSS 'Visual' and 'Inattention and Extinction' subscales) 4. Unstable medical conditions e.g. angina not controlled by medication 5. Unable to understand or communicate in English (i.e. unable to follow instructions as assessed by 2-point command) 6. Fixed contracture or active disease (e.g. rheumatoid arthritis) affecting movement that will reduce the ability to use the Gameball.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current version as of 17/04/2018: All participants will be assessed at baseline (week 0), post intervention (week 8) and follow up (week 12). Safety: 1. Pain is assessed in the upper limb (fingers, hand, wrist, forearm, elbow, upper arm and shoulder) and trunk using a visual analogue scale at each assessment point and by the pain related question on the EQ-5D-5L. 2. Fatigue is assessed by the 7-item Fatigue Severity Scale (FSS-7) at each assessment point. 3. Number and type of adverse events will be assessed by asking participants if they have experienced arm pain, a fall or other adverse event at each assessment point. Adverse events will be categorised as either expected or unexpected. Acceptability of the intervention will be assessed by: 1. Participant reported experience using the post-intervention questionnaire and by conducting semi-structured interviews with 15 participants. Interview participants will be purposively sampled from the cohort. Feasibility of delivering the intervention will be assessed by: 1. Diary logs from the research assistants and technicians of their experience of supporting the intervention. 2. The number and length of technical related calls 3. The number and length of clinical related calls Feasibility of conducting a definitive tria will be assessed by: 1. Monitoring recruitment and retention rates 2. Identifying reasons for non-participation using a questionnaire distributed to people who did not wish to take part in the study 3. Identifying reasons for withdrawal from the study using a questionnaire distributed to people who withdrew from the study 4. Monitoring the completion rate of outcome measures related to the clinical and cost effectiveness of the trial Original version: All participants will be assessed at baseline (week 0), post intervention (week 7) and follow up (week 11). Safety: 1. Pain is assessed in the upper limb (fingers, hand, wrist, forearm, elbow, upper arm and shoulder) and trunk using a visual analog | — |
Secondary
| Measure | Time frame |
|---|---|
| Current version as of 17/04/2018: The following outcome assessments will be assessed for all participants at baseline (week 0), post-intervention (8 weeks) and follow-up (12 weeks). These outcomes are the proposed outcomes that will be used to determine the clinical and cost effectiveness of the intervention if a definitive trial is conducted. The following measures will be assessed at all time points. 1. Objective arm function assessed by the Action Research Arm Test (ARAT) 2. Arm impairment assessed by Fugl-Meyer (FMA – upper limb) 3. Passive Range of Movement (PROM) assessed by goniometry 4. Spasticity assessed by Modified modified Ashworth Scale (MMAS) 5. Self reported arm function assessed by the Motor Activity Log -14 (MAL) 6. Social integration (participation) assessed by the Subjective Index of Physical and Social Outcome (SIPSO) 7. Quality of life assessed by the EQ-5D-5L 8. Health service use assessed by the Adapted Client Service Receipt Inventory (CSRI) 9. Pain assessed by Visual Analogue Scale (VAS) 10. Fatigue assessed by Fatigue Severity Scale-7 (FSS-7) 11. Global disability assessed by the simplified modified Rankin Scale questionnaire (smRSq) Original version: The following outcome assessments will be assessed for all participants at baseline (week 0), post-intervention (6 weeks) and follow-up (10 weeks). These outcomes are the proposed outcomes that will be used to determine the clinical and cost effectiveness of the intervention if a definitive trial is conducted. The following measures will be assessed at all time points. 1. Objective arm function assessed by the Action Research Arm Test (ARAT) 2. Arm impairment assessed by Fugl-Meyer (FMA – upper limb) 3. Passive Range of Movement (PROM) assessed by goniometry 4. Spasticity assessed by Modified modified Ashworth Scale (MMAS) 5. Self reported arm function assessed by the Motor Activity Log -14 (MAL) 6. Social integration (participation) assessed by the Subjective Index of Physical | — |
Countries
England, United Kingdom
Contacts
Public ContactCherry Kilbride
Outcome results
None listed