Effect of an Aqua Stand-Up Paddle Program on Postural Instability in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Mini-Balance Evaluation System Score variation
研究概览
简要总结
Postural instability is associated with falls and a decreased quality of life in Parkinson's disease (PD). Evidence supports physical activity rather than levodopa for postural instability management. Considering the proven effects of the Stand-up Paddle (SUP) activity on postural instability in sedentary people, the investigators wanted to develop this aquatic activity in a swimming pool on static conditions (Aqua SUP) for PD patients. The objective is to assess the postural instability change by measuring the Mini-Balance Evaluation Systems Test (miniBESTest) after 8 weeks of Aqua SUP compared to physiotherapy in PD patients with baseline postural instability.
详细描述
Parkinson's disease (PD) is a relentless neurodegenerative disorder leading to functional impairment with postural instability. Postural instability is associated with an increased risk of falling and a decreased quality of life, and levodopa therapy may only have little effect on balance. Evidence supports physiotherapy and physical activity as an alternative treatment for postural instability in PD. Several types of physical activity have been tested in PD which target different specificities of rehabilitation such as stretching, muscle strengthening, balance, occupational therapy, cueing, treadmill training, with contrasting data regarding postural instability. The investigators want to develop an innovative physical activity with specific focus on the management of the postural instability in PD patients. Stand-up Paddle (SUP) is an aquatic sport improving postural instability in sedentary people that may be practiced in a swimming pool with static conditions for safety (Aqua SUP).
In order to assess the effect on postural instability, PD patients with baseline postural instability will be scored by Mini-Balance Evaluation Systems Test (miniBESTest) before and after 8 weeks of Aqua SUP practice and compared to physiotherapy according to a randomized controlled trial with non-inferiority design.
Patients will be clinically assessed at baseline regarding the primary outcome miniBESTest and secondary outcome measures. A secondary visit will take place at 2 months after inclusion (Aqua SUP versus physiotherapy). A tertiary visit will be completed at 6 months after inclusion to assess long term effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Patients will be scored Mini-Balance evaluation System Test by blinded investigators, before and after AquaSup or Physiotherapy
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female aged 18 to 80 years of age.
- •Patients suffering from idiopathic Parkinson's Disease according to the criteria of the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic.
- •Presence of balance disorder : Stage Hoehn and Yahr 2.5 to
- •Motor level stable, without change of treatment in last 6 weeks
- •Subjects affiliated to a social security scheme or beneficiary of an equivalent scheme
- •Subjects are volunteers with their signed consent
排除标准
- •Patients suffering from disabling neurological conditions other than IPD. Patients with progressive psychiatric pathologies.
- •Patients with significant cognitive impairment (MMS <24).
- •Presence of orthopedic problems incompatible with the practice of Aqua SUP.
- •Medical advice against the practice of endurance exercise and muscle building.
- •Patients with history or presence of cardiovascular or respiratory conditions, or patients who answered "yes" to any of the items in the Revised Physical Activity Readiness Questionnaire (Q-AAP).
- •Patients with a condition which is deemed incompatible with the therapeutic pool: uncontrolled vesico-sphincteric disorder, aquaphobia, deterioration of the skin condition (wound, eschar, ulcer).
- •Persons subject to decision making support (eg. legal guardianship or conservator).
- •Patients in the process of participating in another study.
- •Pregnant woman.
结局指标
主要结局
Mini-Balance Evaluation System Score variation
时间窗: Change from baseline Mini-Balance Evaluation Systems Test at 2 months.
Mini-Balance Evaluation System Test : Postural instability with falling risk evaluation, 14 items quoted 0 (severe) to 2 (normal). Total score recorded : minimum =0 Maximum =28. Higher values represent a better outcome
次要结局
- Mini-Mental State Examination score variation(Change from baseline Mini-Mental State Examination: at 2 months)
- Posturographic data (Satel Platform) variation(Change from baseline Posturographic data at 2 months)
- Global Mobility Task score variation(Change from baseline Global Mobility Task at 2 months)
- Temporo-spatial parameters of gait (GAITRite walkway system) variation(Change from baseline Temporo-spatial parameters of GAITRite walkway system at 2 months)
- Beck Depression Inventory score variation(Change from baseline Beck Depression Inventory at 2 months)
- Isokinetic lower-limb muscle strength results variation(Change from baseline Isokinetic lower-limb muscle strength at 2 months)
- Modified Timed Up and Go score variation(Change from baseline Modified Modified Timed Up and Go at 2 months)
- Maximal oxygen uptake (V02max) results variation(Change from baseline Maximal oxygen uptake at 2 months)
- Movement Disorder Society - Unified Parkinson's Disease rating Scale III score variation(Change from baseline Movement Disorder Society - Unified Parkinson's Disease rating Scale III at 2 months)
- Berg Balance Scale score variation(Change from baseline Berg Balance Scale at 2 months)
- Clinical Global Impression (CGI) score variation(Change from beseline Clinical Global Impression at 2 months)
- 2 minutes walking test score variation(Change from baseline 2 minutes walking test 2 months)
- Parkinson's Disease Questionnaire 39-item score variation(Change from baseline Parkinson's Disease Questionnaire 39-item at 2 months)
研究者
FLABEAU Olivier
Hospital practitionner
Centre Hospitalier de la côte Basque