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

Primary Purpose

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

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Aquatic rehabilitation

Land based physical activities

Conventional rehabilitation

About this trial

This is an interventional supportive care trial for Interest of Hydrophysiotherapy Care in Parkinson Disease's Non-motor Symptoms focused on measuring Parkinson's disease, Non motor signs, Postural control, Gait, Hydrophysiotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Arm Label

Aquatic rehabilitation

Land based physical activities

Conventional rehabilitation

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

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

Non-Motors Signs (NMS) Questionnaire score

Questionnaire score for NMS (non motor signs) in its globality.

Parkinson Anxiety Scale (PAS) score

Parkinson's Anxiety Scale, evaluating anxiety (between 0 and 30, a lower score being a better outcome).

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)

Global Pain score

Visual Analogic Scale (VAS) (between 0 and 10, a lower score being a better score)

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).

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)

Ratio of sensory inputs.

Ratio of sensory inputs in postural control (somatosensory, visual and vestibular ratios).

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.

Time for Time Up and Go (TUG)

Timed Up and Go

Distance of walking

Distance walked during the 6 min walk test

Walking velocity

Mean velocity during the 6 min walk test.

Step high

Mean step high during the 6 min walk test.

Step length

Mean step length during the 6 min walk test.

Step width

Mean step width during the 6 min walk test.

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.

Full Information

NCT ID

NCT03960931

First Posted

April 12, 2019

Last Updated

June 21, 2019

Sponsor

Central Hospital, Nancy, France

Collaborators

Institut Régional de Médecine Physique et de Réadaptation

1. Study Identification

Unique Protocol Identification Number

NCT03960931

Brief Title

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

Acronym

THERMAPARK

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Unknown status

Study Start Date

July 1, 2019 (Anticipated)

Primary Completion Date

September 30, 2021 (Anticipated)

Study Completion Date

November 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Central Hospital, Nancy, France

Collaborators

Institut Régional de Médecine Physique et de Réadaptation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Parkinson's disease, Non motor signs, Postural control, Gait, Hydrophysiotherapy

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Aquatic rehabilitation

Arm Type

Experimental

Arm Title

Land based physical activities

Arm Type

Experimental

Arm Title

Conventional rehabilitation

Arm Type

Other

Intervention Type

Other

Intervention Name(s)

Aquatic rehabilitation

Other Intervention Name(s)

Hydrophysiotherapy

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Land based physical activities

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Conventional rehabilitation

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change of score on Parkinson's Disease Questionnaire 39 (PDQ 39) after reeducation

Description

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

Time Frame

Day 1, day 28 (+7)

Secondary Outcome Measure Information:

Title

Persistence of change of score on PDQ 39 after reeducation

Description

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.

Time Frame

Day 28(+7), day 56 (+/-7)

Title

PDQ 39 sub-scores

Description

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

Time Frame