An Investigation Into Neuropilates on Motor Function in Chronic Stroke: a Pilot Randomised Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Motor Assessment Scale (Carr and Shepherd 1985).
研究概览
简要总结
This is a pilot randomised controlled feasibility study investigating the effects of a neuropilates exercise class compared to a generalised exercise in the post stroke population. This study is being conducted as part of an MSc qualification at the Institute of Technology, Sligo in Ireland. The study will be conducted in conjunction with Sligo University Hospital and it attained ethical approval through the relevant University Hospital Ethics Committee.
详细描述
Pilates is an exercise form created by Joseph Pilates in the 1920s. It is a programme of mind-body exercise focusing on strength, core stability, flexibility, muscle control, posture and breathing. Neuropilates is the practice of clinical pilates in patients with a neurological condition. The exercise is ideally led by a clinician with experience and expertise in the area and uses postural, positional and equipment adaptations as necessary to suit the needs of the client. The benefits derived from pilates exercise of balanced strength with improved alignment, postural control and flexibility, could be favourable to post stroke patients who often have one-sided loss of strength and muscle length and subsequent adverse postural adaptations and abnormal movement patterns.
This study aims to investigate the effects of a 6-week neuropilates class in post stroke patients, when compared with a 6-week generalised exercise class. Participants will be assessed before and after partaking in either class in order to examine their gait, functional independence and spasticity. Participants will then be randomly assigned to either the 6-week neuropilates class or generalised exercise class. Participants will be 6 or more months post stroke and finished their formal rehabilitation. Participants should not be involved with any other rehabilitation therapies / hydrotherapy / gym services for the duration of the study. We will aim to recruit 30 participants to the study. The intervention group will attend a once-weekly 60-minute neuropilates exercise class over 6 weeks facilitated by the principle investigator (a chartered physiotherapist who is also a pilates instructor). The control group will attend a once weekly, 60-minute generalized exercise class which will be designed by a chartered physiotherapist to address strength, cardiorespiratory fitness and mobility. Both exercise classes will take place in the Physiotherapy Department in St. John's Hospital, Sligo, Ireland
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)
盲法说明
Outcome assessor will be blinded to treatment allocation. They will evaluate participant's prior to neuropilates treatment commencing and after neuropilates 6 week treatment has been completed.
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
- •Aged > 18 years
- •Diagnosis of chronic stroke (>6 months post stroke event, as defined by Bernhardt et al, 2017) and formal rehabilitation completed.
- •Able to transfer (sit to stand and lateral transfers) independently with or without assistive device
- •Access to transport to enable attendance at one class per week
- •Cognitive ability to understand the programme.
排除标准
- •Involvement in other studies or rehabilitation programmes.
- •Severe cognitive deficits or difficulty following instructions.
- •Significant hearing difficulties.
- •Significant visual deficit
- •Uncontrolled pain or uncontrolled high blood pressure
研究组 & 干预措施
Neuropilates class.
Will attend a once-weekly 60-minute neuropilates exercise class over 6 weeks facilitated by the principle investigator (chartered physiotherapist and pilates instructor).
Pitched at a beginner level focused on the core elements of neuropilates and progressing week on week as appropriate.
Includes a warm up, cool down and neuropilates exercises in line with the teaching of APPI (the Australian Physiotherapy and Pilates Institute). Exercises may be completed on mats, chairs, gym balls, plinths and in standing, depending upon the ability level of the participant.
Two classes running with 8 participants in each based on their initial assessment into the higher and lower functionally independent participants.
Participants will be given a home exercise programme weekly based on exercises from the class and will be asked to complete these independently at home twice more during the week and to keep a training diary.
干预措施: Home 'Neuropilates' exercise instructions. (Procedure)
Neuropilates class.
Will attend a once-weekly 60-minute neuropilates exercise class over 6 weeks facilitated by the principle investigator (chartered physiotherapist and pilates instructor).
Pitched at a beginner level focused on the core elements of neuropilates and progressing week on week as appropriate.
Includes a warm up, cool down and neuropilates exercises in line with the teaching of APPI (the Australian Physiotherapy and Pilates Institute). Exercises may be completed on mats, chairs, gym balls, plinths and in standing, depending upon the ability level of the participant.
Two classes running with 8 participants in each based on their initial assessment into the higher and lower functionally independent participants.
Participants will be given a home exercise programme weekly based on exercises from the class and will be asked to complete these independently at home twice more during the week and to keep a training diary.
干预措施: Supervised Neuropilates Group Class (Procedure)
Generalised exercise class.
Will attend a once weekly, 60-minute generalized exercise class which will be designed by a chartered physiotherapist to address strength, cardiorespiratory fitness and mobility.
Exercises will be more functional and generic than in the pilates classes and will be conducted in a circuit style, including mobility practice, sit to stand practice, cycling with the motomed, and general upper and lower limb strengthening. Warm up and cool downs will also be a feature of this class.
Participants will be also be given a home exercise programme based on exercises completed in the class and will be asked to complete these exercises twice more during the week and to keep a training diary.
干预措施: Home 'General' exercise instructions. (Procedure)
Generalised exercise class.
Will attend a once weekly, 60-minute generalized exercise class which will be designed by a chartered physiotherapist to address strength, cardiorespiratory fitness and mobility.
Exercises will be more functional and generic than in the pilates classes and will be conducted in a circuit style, including mobility practice, sit to stand practice, cycling with the motomed, and general upper and lower limb strengthening. Warm up and cool downs will also be a feature of this class.
Participants will be also be given a home exercise programme based on exercises completed in the class and will be asked to complete these exercises twice more during the week and to keep a training diary.
干预措施: Supervised General Exercises Group Class (Procedure)
结局指标
主要结局
Motor Assessment Scale (Carr and Shepherd 1985).
时间窗: Over a 6 week period. (15 min testing time).
A performance-based scale to assess everyday motor function in post stroke patients. Evaluation is based upon a task-orientated approach. The scale comprises 8 items corresponding to 8 areas of motor function. Patients perform each task 3 times and the best performance is recorded. Tasks include; Supine to side lying, Supine to sitting over the edge of a bed, Balanced sitting, Sitting to standing, Walking, Upper-arm function, Hand movements, Advanced hand activities. General tonus of the affected side is also measured. All items (with the exception of the general tonus item) are assessed using a 7-point scale from 0 - 6. A score of 6 indicates optimal motor behaviour. For the general tonus item, the score is based on continuous observations throughout the assessment. A score of 4 on this item indicates a consistently normal response. A score \> 4 indicates persistent hypertonus and a score \< 4 indicates various degrees of hypotonus. The maximum score possible is 48 points.
次要结局
- Gait Analysis: Timed Up and Go Test (Shumway-Cook et al, 2000).(Over a 6 week period. (1 min testing time).)
- Muscle Strength: Oxford Grading Scale.(Over a 6 week period. (5-20 min testing time).)
- Spasticity: Modified Ashworth Scale (Bohannon and Smith 1987).(Over a 6 week period. (5-20 min testing time).)
- Function: Functional Independence Measure (FIM), (Granger et al 1993).(Over a 6 week period. (30-45 min testing time).)
- London Handicap Scale (LHS), (Harwood et al 1994).(Over a 6 week period. (5 min testing time).)
研究者
Dr. John Bartlett
Head of Research
Institute of Technology, Sligo