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

Not Applicable

• Conditions: Interest of Hydrophysiotherapy Care in Parkinson Disease's Non-motor Symptoms
• Interventions: Other: Aquatic rehabilitation; Other: Land based physical activities; Other: Conventional rehabilitation

• Registration Number: NCT03960931
• Lead Sponsor: Central Hospital, Nancy, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-12
• Study First Submitted QC: 2019-05-21
• Study First Posted: 2019-05-23
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-21
• Last Update Posted: 2019-06-25
• Study Start: 2019-07-01
• Primary Completion: 2021-09-30
• Study Completion: 2021-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aquatic rehabilitation	Aquatic rehabilitation	-
Land based physical activities	Land based physical activities	-
Conventional rehabilitation	Conventional rehabilitation	-

Primary Outcome Measures

Name	Time	Method
Change of score on Parkinson's Disease Questionnaire 39 (PDQ 39) after reeducation	Day 1, day 28 (+7)	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

Secondary Outcome Measures

Name	Time	Method
Non-Motors Signs (NMS) Questionnaire score	Day 1, day 28 (+7), day 56 (+/-7)	Questionnaire score for NMS (non motor signs) in its globality.
Mean Equilibrium ellipse area	Day 1, day 28 (+7), day 56 (+/-7)	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)
Ratio of sensory inputs.	Day 1, day 28 (+7), day 56 (+/-7)	Ratio of sensory inputs in postural control (somatosensory, visual and vestibular ratios).
Step width	Day 1, day 28 (+7), day 56 (+/-7)	Mean step width during the 6 min walk test.
Persistence of change of score on PDQ 39 after reeducation	Day 28(+7), day 56 (+/-7)	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.
Distance of walking	Day 1, day 28 (+7), day 56 (+/-7)	Distance walked during the 6 min walk test
PDQ 39 sub-scores	Day 1, day 28 (+7), day 56 (+/-7)	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
Mean Equilibrium path length	Day 1, day 28 (+7), day 56 (+/-7)	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).
Step high	Day 1, day 28 (+7), day 56 (+/-7)	Mean step high during the 6 min walk test.
Subjective effort	Day 1, day 28 (+7), day 56 (+/-7)	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.
Parkinson's Disease specific Pain score	Day 1, day 28 (+7), day 56 (+/-7)	King's Parkinson's Disease Pain Scale (KPPS, between 0 and 168, a lower score being a better outcome)
Global Pain score	Day 1, day 28 (+7), day 56 (+/-7)	Visual Analogic Scale (VAS) (between 0 and 10, a lower score being a better score)
Entropy	Day 1, day 28 (+7), day 56 (+/-7)	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.
Step length	Day 1, day 28 (+7), day 56 (+/-7)	Mean step length during the 6 min walk test.
Parkinson Anxiety Scale (PAS) score	Day 1, day 28 (+7), day 56 (+/-7)	Parkinson's Anxiety Scale, evaluating anxiety (between 0 and 30, a lower score being a better outcome).
Time for Time Up and Go (TUG)	Day 1, day 28 (+7), day 56 (+/-7)	Timed Up and Go
Walking velocity	Day 1, day 28 (+7), day 56 (+/-7)	Mean velocity during the 6 min walk test.