Interest of Hydrophysiotherapy Care in Parkinson Disease's Motor and Non-motor Symptoms

Study Overview
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Brief Summary
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Parkinson Disease (PD) is a neurodegenerative disorder who begin around 55 years old, characterized by brain's backmatter's dopamine neuron destruction, involved in motor control. Diagnosis is made with presence of 3 of 4 disease's cardinal sign: bradykinesia, rigidity, resting tremor, walking troubles. Treatments enhance patient's quality of life, but do not allow to stop disease's evolution, who is specific depending on a lot of factors. For some years, PD's non motor symptoms (NMS) - in particular pain, anxiety, depression, sleep disorders - have been highlighted and turn out to impair sometimes quality of life even though motor symptoms are controlled. This project's main aim is to evaluate if aquatic environment's care lead to an advantage on PD's NMS, symptoms currently underestimated, insufficiently in care and having a harmful influence on quality of life. Collaboration of the University Hospital (Neurology Dpt), the Physical Medicine and Rehabilitation Regional Institute, Grand Nancy Thermal, and France Parkinson Association, will allow in this way to offer on PD's NMS, postural control impairments, and walking troubles an alternative or further non-pharmacological therapy.

Official Title
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Interest of Hydrophysiotherapy Care in Parkinson Disease's Non-motor Symptoms

Conditions
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Interest of Hydrophysiotherapy Care in Parkinson Disease's Non-motor Symptoms

Intervention / Treatment
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* Other: Aquatic rehabilitation
* Other: Land based physical activities
* Other: Conventional rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria, patient: having get a complete information on study's organization and having given written informed consent, affiliated to a social security system, suffering from Parkinson's disease (stage 2 or 3 of Hoehn and Yahr), with motor fluctuation lower than 25% of awaked time, with dyskinesia lower than 25% of awaked time (according to MDS-UPDRS scale), with stable pharmacological treatment during the 30 days before study, already benefiting of a physiotherapy. Exclusion Criteria, patients: receiving treatment by apomorphine or Duodopa pump, benefiting of brain stimulation, taking occasionally benzodiazepine, with dementia (MDS-UPDRS 1.1 score > 3), having had a sprain on a lower limb joint 3 months or less before the beginning of study, having head trauma consequences, having vertebrae pain, with freezing, having skin trouble leading to a contraindication of aquatic activities, concerned by L. 1121-5, L. 1121-7 and L 1121-8 articles of French public health code.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aquatic rehabilitation<br> | Other: Aquatic rehabilitation<br>* Rehabilitation sessions using hydrophysiotherapy will occur in a pool of Grand Nancy Thermal, three times per week during 4 weeks, and each will last 45 min. They will begin with 10 min of warm-up, then 30 min of walking. Sessions will end cool-down during 5 min, which will be a reduction of intensity every 30 sec. Rehabilitation will be carried out by physiotherapist chosen for the study.<br>* Other names: Hydrophysiotherapy;|
| Experimental: Land based physical activities<br> | Other: Land based physical activities<br>* Rehabilitation sessions on treadmill will occur at Physical Medicine and Rehabilitation Regional Institute (IRR), on the University Hospital's site, three times per week during 4 weeks, and each will last 45 min. They will begin with 10 min of warm-up, then 30 min of walking, where intensity of effort can be modulated by speed and inclination of treadmill. Sessions will end cool-down during 5 min, which will be a reduction of intensity every 30 sec. Rehabilitation will be carried out by physiotherapist chosen for the study.<br>|
| Other: Conventional rehabilitation<br> | Other: Conventional rehabilitation<br>* Conventional rehabilitation sessions will occur in private practices in which patients receive their habitual care (same physiotherapist). This care will be guided by prescription delivered by the neurologist. This prescription suggests to work on active and passive upper and lower limb stretching, on hip and shoulder dissociation, and balance control management on unstable ground.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of score on Parkinson's Disease Questionnaire 39 (PDQ 39) after reeducation | Total score to PDQ 39 (between 0 and 156, a lower score being a better outcome), which evaluates quality of life, before and after reeducation | Day 1, day 28 (+7) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistence of change of score on PDQ 39 after reeducation | Total score to Parkinson Disease Questionnaire 39 (between 0 and 156, a lower score being a better outcome), which evaluates quality of life, before and after reeducation. | Day 28(+7), day 56 (+/-7) | 
| PDQ 39 sub-scores | Sub-score for each of the 8 fields composing PDQ 39: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication and bodily discomfort | Day 1, day 28 (+7), day 56 (+/-7) | 
| Non-Motors Signs (NMS) Questionnaire score | Questionnaire score for NMS (non motor signs) in its globality. | Day 1, day 28 (+7), day 56 (+/-7) | 
| Parkinson Anxiety Scale (PAS) score | Parkinson's Anxiety Scale, evaluating anxiety (between 0 and 30, a lower score being a better outcome). | Day 1, day 28 (+7), day 56 (+/-7) | 
| Parkinson's Disease specific Pain score | King's Parkinson's Disease Pain Scale (KPPS, between 0 and 168, a lower score being a better outcome) | Day 1, day 28 (+7), day 56 (+/-7) | 
| Global Pain score | Visual Analogic Scale (VAS) (between 0 and 10, a lower score being a better score) | Day 1, day 28 (+7), day 56 (+/-7) | 
| Mean Equilibrium path length | Corresponding to the mean path length travelled by displacement of the Centre of Foot Pressure in four conditions (eyes open or closed, firm or foamed support). | Day 1, day 28 (+7), day 56 (+/-7) | 
| Mean Equilibrium ellipse area | Corresponding to the mean ellipse area covered by displacement of the Centre of Foot Pressure in four conditions (eyes open or closed, firm or foamed support) | Day 1, day 28 (+7), day 56 (+/-7) | 
| Ratio of sensory inputs. | Ratio of sensory inputs in postural control (somatosensory, visual and vestibular ratios). | Day 1, day 28 (+7), day 56 (+/-7) | 
| Entropy | Entropy mathematically evaluates the displacements regularity of the Center of Foot Pressure (CoP). If the CoP displacements are regular (lower entropy), intentionally processes are more implicated in postural control regulation. If the CoP displacements are not regular (higher entropy), automatic processes are more implicated in postural control regulation. Entropy comparison between a single and a dual task is analyzed. | Day 1, day 28 (+7), day 56 (+/-7) | 
| Time for Time Up and Go (TUG) | Timed Up and Go | Day 1, day 28 (+7), day 56 (+/-7) | 
| Distance of walking | Distance walked during the 6 min walk test | Day 1, day 28 (+7), day 56 (+/-7) | 
| Walking velocity | Mean velocity during the 6 min walk test. | Day 1, day 28 (+7), day 56 (+/-7) | 
| Step high | Mean step high during the 6 min walk test. | Day 1, day 28 (+7), day 56 (+/-7) | 
| Step length | Mean step length during the 6 min walk test. | Day 1, day 28 (+7), day 56 (+/-7) | 
| Step width | Mean step width during the 6 min walk test. | Day 1, day 28 (+7), day 56 (+/-7) | 
| Subjective effort | Ratio of Perceived Exertion (RPE) score, evaluated by Borg Scale (according to the 6 min walk test). Score is between 6 and 20, 6 being a better outcome. | Day 1, day 28 (+7), day 56 (+/-7) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, Non motor signs, Postural control, Gait, Hydrophysiotherapy