Aqua Stand-Up Paddle Balance Effect in Parkinson's Disease (AquaSUP PARK)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of an Aqua Stand-Up Paddle Program on Postural Instability in Parkinson's Disease

Conditions
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Parkinson Disease, Rehabilitation

Intervention / Treatment
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* Procedure: Stand-Up Paddle Rehabilitation
* Procedure: Physiotherapy Rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 4. 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Proof of concept. Study of non-inferiority, prospective, monocentric, randomized, controlled (Aqua SUP vs physiotherapy), in blind treatment compared to applied treatment.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aqua SUP<br>Patients in the Aqua SUP group will benefit from a 1 hour Aqua SUP session, twice a week, for 8 weeks in a therapeutic pool. | Procedure: Stand-Up Paddle Rehabilitation<br>* Patients in the Aqua SUP group will benefit from a 1 hour Aqua SUP session, twice a week, for 8 weeks in a therapeutic pool.<br>|
| Active Comparator: Physiotherapy<br>Patients in the control group will receive a conventional physiotherapy session of 1 hour, twice a week, for 8 weeks. | Procedure: Physiotherapy Rehabilitation<br>* Patients in the control group will receive a conventional physiotherapy session of 1 hour, twice a week, for 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini-Balance Evaluation System Score variation | 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 | Change from baseline Mini-Balance Evaluation Systems Test at 2 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Movement Disorder Society - Unified Parkinson's Disease rating Scale III score variation | Movement Disorder Society - Unified Parkinson's Disease rating Scale III : Motor symptoms evaluation, 18 items quoted 0 (normal) to 4 (severe). Total score recorded : minimum =0 Maximum =72. Higher values represent a worse outcome | Change from baseline Movement Disorder Society - Unified Parkinson's Disease rating Scale III at 2 months | 
| Berg Balance Scale score variation | Berg Balance Scale test : Balance and posture evaluation, 14 items quoted 0(normal) to 3 (severe). Total score recorded : Minimum=0 Maximum = 42. Higher values represent a worse outcome | Change from baseline Berg Balance Scale at 2 months | 
| Mini-Mental State Examination score variation | Mini-Mental State Examination test : Cognitice capacity evaluation, 6 items evaluated. Total score recorded : Minimum = 0 Maximum = 30 . Higher values represent a better outcome | Change from baseline Mini-Mental State Examination: at 2 months | 
| Modified Timed Up and Go score variation | Modified Timed Up and Go Test : Functionnal capacity evaluation, Timing Walking test. Higher values represent a worse outcome | Change from baseline Modified Modified Timed Up and Go at 2 months | 
| Global Mobility Task score variation | Global Mobility Task Test : Functionnal capacity evaluation; 5 items quoted 0(normal) to 4 (severe). Total score recorded : Minimum=0 Maximum = 20. Higher values represent a worse outcome | Change from baseline Global Mobility Task at 2 months | 
| 2 minutes walking test score variation | 2 minutes walking test : Timing Walking test. Higher values represent a better outcome | Change from baseline 2 minutes walking test 2 months | 
| Posturographic data (Satel Platform) variation | Posturographic data test : Statokinesigram and stabilogram | Change from baseline Posturographic data at 2 months | 
| Temporo-spatial parameters of gait (GAITRite walkway system) variation | Temporo-spatial parameters of GAITRite walkway system test : Walking test : lengh, timing and speed recorded. Higher values represent a better outcome for speed and lengh | Change from baseline Temporo-spatial parameters of GAITRite walkway system at 2 months | 
| Parkinson's Disease Questionnaire 39-item score variation | Parkinson's Disease Questionnaire 39-item test : Quality of life evaluation; 39 items quoted never rarely sometimes often or always. | Change from baseline Parkinson's Disease Questionnaire 39-item at 2 months | 
| Beck Depression Inventory score variation | Beck Depression Inventory test : depression evaluation . 21 items quoted 0(normal) to 3 (severe). Total score recorded : Minimum=0 Maximum = 63. Higher values represent a worse outcome | Change from baseline Beck Depression Inventory at 2 months | 
| Clinical Global Impression (CGI) score variation | Clinical Global Impression test : Global improvement evaluation : 1 item quoted 1 (very high improvement) to 7 (very high worsening). Higher value represent a worse outcome | Change from beseline Clinical Global Impression at 2 months | 
| Isokinetic lower-limb muscle strength results variation | Isokinetic lower-limb muscle strength test : muscular strenght evaluation. Right anf left quadriceps and harmstrings strenght evaluation. Higher values represent a better outcome | Change from baseline Isokinetic lower-limb muscle strength at 2 months | 
| Maximal oxygen uptake (V02max) results variation | Maximal oxygen uptake test : cardio-respiratory capacity evaluation. Higher value represent a better outcome | Change from baseline Maximal oxygen uptake at 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation, Parkinson's Disease, Balance, Aquatic therapy, Stand Up Paddle