ISRCTN82280581进行中（未招募）未知
A multicentre pilot cluster randomised controlled trial evaluating an intervention to reduce sedentary behaviour in stroke survivors incorporating an embedded process evaluation
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 400
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
- •2. A family member/close friend/carer of a stroke survivor participating in the study and identified by the stroke survivor as someone they engage with on a regular basis (meet at least once a fortnight)
- •3. Able and willing to provide written informed consent
- •Previous participant inclusion criteria:
- •All stroke survivors with the following characteristics are eligible for this trial:
- •1. New or recurrent clinically diagnosed ischaemic or haemorrhagic (excluding subarachnoid haemorrhage) stroke
- •2. Requires 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 in keeping with Functional Ambulatory Categories [Holden et al, 1984] (FAC) 3-6
- •3. Planned discharge to live in the community (not to a care home)
- •4. 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 walk (FAC score=3) to those able to walk independently anywhere (FAC score=6)
- •Family/friends /carer will be eligible for the study provided they are:
- •1. Aged 16 years or over
- •2. A family member/close friend/carer of a stroke survivor participating in the study and identified by the stroke survivor as someone they engage with on a regular basis (meet at least once a fortnight)
- •3. Able and willing to provide written informed consent
排除标准
- •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
研究者
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