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

June 21, 2019 updated by: Central Hospital, Nancy, France

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
126

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of score on Parkinson's Disease Questionnaire 39 (PDQ 39) after reeducation
Time Frame: 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
Day 1, day 28 (+7)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Persistence of change of score on PDQ 39 after reeducation
Time Frame: 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.
Day 28(+7), day 56 (+/-7)
PDQ 39 sub-scores
Time Frame: 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
Day 1, day 28 (+7), day 56 (+/-7)
Non-Motors Signs (NMS) Questionnaire score
Time Frame: Day 1, day 28 (+7), day 56 (+/-7)
Questionnaire score for NMS (non motor signs) in its globality.
Day 1, day 28 (+7), day 56 (+/-7)
Parkinson Anxiety Scale (PAS) score
Time Frame: 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).
Day 1, day 28 (+7), day 56 (+/-7)
Parkinson's Disease specific Pain score
Time Frame: 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)
Day 1, day 28 (+7), day 56 (+/-7)
Global Pain score
Time Frame: Day 1, day 28 (+7), day 56 (+/-7)
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
Time Frame: 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).
Day 1, day 28 (+7), day 56 (+/-7)
Mean Equilibrium ellipse area
Time Frame: 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)
Day 1, day 28 (+7), day 56 (+/-7)
Ratio of sensory inputs.
Time Frame: Day 1, day 28 (+7), day 56 (+/-7)
Ratio of sensory inputs in postural control (somatosensory, visual and vestibular ratios).
Day 1, day 28 (+7), day 56 (+/-7)
Entropy
Time Frame: 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.
Day 1, day 28 (+7), day 56 (+/-7)
Time for Time Up and Go (TUG)
Time Frame: Day 1, day 28 (+7), day 56 (+/-7)
Timed Up and Go
Day 1, day 28 (+7), day 56 (+/-7)
Distance of walking
Time Frame: Day 1, day 28 (+7), day 56 (+/-7)
Distance walked during the 6 min walk test
Day 1, day 28 (+7), day 56 (+/-7)
Walking velocity
Time Frame: Day 1, day 28 (+7), day 56 (+/-7)
Mean velocity during the 6 min walk test.
Day 1, day 28 (+7), day 56 (+/-7)
Step high
Time Frame: Day 1, day 28 (+7), day 56 (+/-7)
Mean step high during the 6 min walk test.
Day 1, day 28 (+7), day 56 (+/-7)
Step length
Time Frame: Day 1, day 28 (+7), day 56 (+/-7)
Mean step length during the 6 min walk test.
Day 1, day 28 (+7), day 56 (+/-7)
Step width
Time Frame: Day 1, day 28 (+7), day 56 (+/-7)
Mean step width during the 6 min walk test.
Day 1, day 28 (+7), day 56 (+/-7)
Subjective effort
Time Frame: 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.
Day 1, day 28 (+7), day 56 (+/-7)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Central Hospital, Nancy, France

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institut Régional de Médecine Physique et de Réadaptation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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