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

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 126
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Aquatic rehabilitation	Other: Aquatic rehabilitation; 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.; Other Names: Hydrophysiotherapy
EXPERIMENTAL: Land based physical activities	Other: Land based physical activities; 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.
OTHER: Conventional rehabilitation	Other: Conventional rehabilitation; 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Collaborators: Institut Régional de Médecine Physique et de Réadaptation

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2019
• Primary Completion (ANTICIPATED): September 30, 2021
• Study Completion (ANTICIPATED): November 30, 2021

Study Registration Dates

• First Submitted: April 12, 2019
• First Submitted That Met QC Criteria: May 21, 2019
• First Posted (ACTUAL): May 23, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 25, 2019
• Last Update Submitted That Met QC Criteria: June 21, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Gait; Parkinson's disease; Postural control; Non motor signs; Hydrophysiotherapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 2019-A00753-54

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No