Clinical trial NCT03960931: Interest of Hydrophysiotherapy Care in Parkinson Disease's Motor and Non-motor Symptoms
Official title: Interest of Hydrophysiotherapy Care in Parkinson Disease's Non-motor Symptoms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Interest of Hydrophysiotherapy Care in Parkinson Disease's Non-motor Symptoms
Keywords: Parkinson's disease
Non motor signs
Postural control
Gait
Hydrophysiotherapy
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: Institut Régional de Médecine Physique et de Réadaptation
First posted: 2019-05-23
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change of score on Parkinson's Disease Questionnaire 39 (PDQ 39) after reeducation
timeFrame: Day 1, day 28 (+7)
Secondary outcomes:
measure: Persistence of change of score on PDQ 39 after reeducation
timeFrame: Day 28(+7), day 56 (+/-7)
measure: PDQ 39 sub-scores
timeFrame: Day 1, day 28 (+7), day 56 (+/-7)
measure: Non-Motors Signs (NMS) Questionnaire score
timeFrame: Day 1, day 28 (+7), day 56 (+/-7)
measure: Parkinson Anxiety Scale (PAS) score
timeFrame: Day 1, day 28 (+7), day 56 (+/-7)
measure: Parkinson's Disease specific Pain score
timeFrame: Day 1, day 28 (+7), day 56 (+/-7)
measure: Global Pain score
timeFrame: Day 1, day 28 (+7), day 56 (+/-7)
measure: Mean Equilibrium path length
timeFrame: Day 1, day 28 (+7), day 56 (+/-7)
measure: Mean Equilibrium ellipse area
timeFrame: Day 1, day 28 (+7), day 56 (+/-7)
measure: Ratio of sensory inputs.
timeFrame: Day 1, day 28 (+7), day 56 (+/-7)
measure: Entropy
timeFrame: Day 1, day 28 (+7), day 56 (+/-7)
measure: Time for Time Up and Go (TUG)
timeFrame: Day 1, day 28 (+7), day 56 (+/-7)
measure: Distance of walking
timeFrame: Day 1, day 28 (+7), day 56 (+/-7)
measure: Walking velocity
timeFrame: Day 1, day 28 (+7), day 56 (+/-7)
measure: Step high
timeFrame: Day 1, day 28 (+7), day 56 (+/-7)
measure: Step length
timeFrame: Day 1, day 28 (+7), day 56 (+/-7)
measure: Step width
timeFrame: Day 1, day 28 (+7), day 56 (+/-7)
measure: Subjective effort
timeFrame: Day 1, day 28 (+7), day 56 (+/-7)
Other outcomes:
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