Development and Pilot Evaluation of a Web-supported Programme of Constraint Induced Therapy Following Stroke (LifeCIT)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Change From Baseline in Upper Limb Impairment: Motor Activity Log (MAL) Quality of Use (QOU)
研究概览
简要总结
When a person has had a stroke they often lose their confidence, motivation and the ability to move one arm and hand. Recent research has shown that intensive exercise assists recovery of movement, but people are often discouraged by slow progress and stop using their weak limb.
A new idea, called Constraint Induced Therapy (CIT), has been shown to overcome this habitual 'non-use'. CIT involves wearing a mitt on the unaffected hand for several hours a day to prevent it from being used. Use of the weak arm and hand is encouraged by intensive exercises. CIT is not available in the NHS because of lack of therapist time for supervision and patients lack the confidence and motivation to carry out CIT alone at home.
This study will have two stages.
Stage 1.
The aim of this part of the study is to develop a web-based therapy programme ('LifeCIT') to support patients carrying out CIT at home (with their carer where possible) with online therapist support. The investigators will develop the therapy programme working closely with at least 12 patients, 6 carers and 6 therapists to identify and resolve any problems.
Stage 2
The investigators will then carry out a pilot trial in 6 treatment centers with 20 patients who have just been discharged from hospital and who have loss of arm and hand function. To test LifeCIT the investigators will randomly allocate patients to receive either the LifeCIT intervention or usual care. A researcher, who doesn't know which group patients have been allocated to, will measure their arm and hand function, record the problems this causes and how it affects their quality of life. Tests will be repeated after treatment (3 weeks) and 6 months later. The investigators will also examine the cost-effectiveness of treatment and ask both therapists and patients for their views.
详细描述
Development and pilot evaluation of a web-supported programme of Constraint Induced Therapy following stroke (LifeCIT) PB-PG-0909-20145
Jane H. Burridge PhD1, Claire Meagher MSc1, Ann-Marie Hughes PhD1, Sean-Ewings PhD2, Ana-Carolina Gonçalves BSc1, Claudia H. S. Alt PhD1, Sebastien Pollet BSc1, Lucy Yardley PhD3
- Rehabilitation and Health Technologies Research Group, Faculty of Health Sciences, University of Southampton, United Kingdom.
- Faculty of Statistical Sciences, University of Southampton, United Kingdom.
- Faculty of Health Psychology, University of Southampton, United Kingdom.
Lay Summary
Background:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of ischaemic or haemorrhagic stroke affecting either right or left upper limb
- •Either: a) Able to transfer safely between toilet, chair and standing and able to walk safely at home wearing the C-MIT with or without the use of a walking aid or b) primarily a wheelchair user having help or supervision to transfer and walk
- •Mini-mental score >23
- •Minimum of 10 degrees of active wrist extension measured by a hand held goniometer
- •Discharged home from hospital (not institutional care)
- •Access to internet at home
排除标准
- •Major medical problems that could interfere with participation
- •Severe pain of the hemiparetic shoulder, arm or hand either at rest or during movement.
- •People for whom communication problems prevent effective use of the system, will be excluded unless they have a carer who can support them effectively.
研究组 & 干预措施
LifeCIT
Participants will be asked to aim to wear the C-MIT for 9 hours a day for 5 days/week, including 4-6 hours of structured activities per day: two 30-60 minute sessions of web-based activities and 3-4 hours practicing everyday activities.
干预措施: LifeCIT (Behavioral)
Standard Care
Participants received their usual care which included home exercises
干预措施: Standard Care (Behavioral)
结局指标
主要结局
Change From Baseline in Upper Limb Impairment: Motor Activity Log (MAL) Quality of Use (QOU)
时间窗: Baseline, Post Intervention (three weeks) and 6 months
he MAL comprises 28 functional items, (e.g. picking up a glass; turning a key to open the door) each item is assessed by self-report on a six-point ordinal scale (0-5). Participants are asked to rate the quality of use of their hemiplegic arm for each item. Zero is scored if they can not use their affected arm, five is scored when they can use their affected arm as well as before their stroke occurred. The final MAL score is calculated as a mean score of the individual items. The minimum and maximum mean scores are 0-5, with higher values representing better outcomes.
Change in Upper Limb Impairment: Motor Activity Log (MAL) Amount of Use (AOU)
时间窗: Baseline, Post intervention (three weeks) and 6 months
The MAL comprises 28 functional items, (e.g. picking up a glass; turning a key to open the door) each item is assessed by self-report on a six-point ordinal scale (0-5). Participants are asked to rate the amount of use of their hemiplegic arm for each item. Zero is scored if they have not used their affected arm, five is scored when they use their affected as often as before their stroke occurred. The final MAL score is calculated as a mean score of the individual items. The minimum and maximum mean scores are 0-5, with higher values representing better outcomes.
次要结局
- Change in Occupational Performance: Canadian Occupational Performance Measure Performance (COPM)(Baseline, Post intervention (three weeks) and 6 months)
- Change in Upper Limb Function: Wolf Motor Function Test (WMFT) Functional Ability Scale (FAS)(Baseline, Post intervention (three weeks), 6 months)
- Change in Upper Limb Impairment: Fugel Myer Upper Extremity (FMUE)(Baseline, Post Intervention (three weeks) and 6 months)
研究者
Jane Burridge, PhD
Professor
University of Southampton