CH Côte Basque
Bayonne, 64109, France
NCT Number: NCT03582371
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.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Bayonne, 64109, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Patients in the control group will receive a conventional physiotherapy session of 1 hour, twice a week, for 8 weeks.
Time frame: 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
Time frame: Change from baseline Movement Disorder Society - Unified Parkinson's Disease rating Scale III at 2 months
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
Time frame: Change from baseline Berg Balance Scale at 2 months
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
Time frame: Change from baseline Mini-Mental State Examination: at 2 months
Mini-Mental State Examination test : Cognitice capacity evaluation, 6 items evaluated. Total score recorded : Minimum = 0 Maximum = 30 . Higher values represent a better outcome
Time frame: Change from baseline Modified Modified Timed Up and Go at 2 months
Modified Timed Up and Go Test : Functionnal capacity evaluation, Timing Walking test. Higher values represent a worse outcome
Time frame: Change from baseline Global Mobility Task at 2 months
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
Time frame: Change from baseline 2 minutes walking test 2 months
2 minutes walking test : Timing Walking test. Higher values represent a better outcome
Time frame: Change from baseline Posturographic data at 2 months
Posturographic data test : Statokinesigram and stabilogram
Time frame: Change from baseline Temporo-spatial parameters of GAITRite walkway system at 2 months
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
Time frame: Change from baseline Parkinson's Disease Questionnaire 39-item at 2 months
Parkinson's Disease Questionnaire 39-item test : Quality of life evaluation; 39 items quoted "never" "rarely" "sometimes" "often" or "always".
Time frame: Change from baseline Beck Depression Inventory at 2 months
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
Time frame: Change from beseline Clinical Global Impression at 2 months
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
Time frame: Change from baseline Isokinetic lower-limb muscle strength at 2 months
Isokinetic lower-limb muscle strength test : muscular strenght evaluation. Right anf left quadriceps and harmstrings strenght evaluation. Higher values represent a better outcome
Time frame: Change from baseline Maximal oxygen uptake at 2 months
Maximal oxygen uptake test : cardio-respiratory capacity evaluation. Higher value represent a better outcome
FLABEAU Olivier
Other
Effect of an Aqua Stand-Up Paddle Program on Postural Instability in Parkinson's Disease
Acronym: AquaSUP PARK
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