ISRCTN82280581
Active, Not Recruiting
N/A
A multicentre pilot cluster randomised controlled trial evaluating an intervention to reduce sedentary behaviour in stroke survivors incorporating an embedded process evaluation
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Bradford Teaching Hospitals NHS Foundation Trust
- Enrollment
- 400
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
Brief Summary
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37518078/ (added 31/07/2023) 2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37699629/ protocol for the process evaluation (added 14/09/2023)
Investigators
Eligibility Criteria
Inclusion Criteria
- •Current participant inclusion criteria as of 25/04/2023:
- •All stroke survivors with the following characteristics are eligible for this trial:
- •1\. Are aged 16 years or over at the time of stroke
- •2\. New or recurrent clinically diagnosed ischaemic or haemorrhagic (excluding subarachnoid haemorrhage) stroke
- •3\. Require manual contact of no more than one person to stand to prevent falling. Manual contact consists of continuous or intermittent light touch to assist balance or coordination (i.e. not to support body weight)
- •4\. Planned discharge to live in the community (not to a care home)
- •5\. Provide written informed consent or Consultee agreement
- •Thus, the study will include a range of abilities from people who need help with balance/coordination to stand to those able to walk independently anywhere.
- •Family/friends /carer will be eligible for the study provided they are:
- •1\. Aged 16 years or over
Exclusion Criteria
- •Current participant exclusion criteria as of 25/04/2023:
- •Stroke survivors will be excluded from the trial if they:
- •1\. Are in receipt of palliative care
- •2\. Are discharged outside the defined geographical area supported by the associated community service(s) participating in the trial Family members/friends/carers will be excluded from the trial if the person with stroke does not consent to the trial
- •Previous participant exclusion criteria:
- •Stroke survivors will be excluded from the trial if they:
- •1\. Are in receipt of palliative care
- •2\. Have an FAC score of 1 (unable to stand without the help of a hoist or two people) or an FAC score of 2 (need continuous support to walk), as they will be unable to amend their behaviour without substantial help
- •3\. Are discharged outside the area supported by the associated community service(s) participating in the trial
- •Family members/friends/carers will be excluded from the trial if the person with stroke does not consent to the trial
Outcomes
Primary Outcomes
Not specified
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