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

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ClinicalTrials.gov Identifier: NCT03960931
Recruitment Status : Not yet recruiting
First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Sponsor:
Collaborator:
Institut Régional de Médecine Physique et de Réadaptation
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Brief Summary:
Parkinson Disease (PD) is a neurorodegenerative 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.

Condition or disease Intervention/treatment Phase
Interest of Hydrophysiotherapy Care in Parkinson Disease's Non-motor Symptoms Other: Aquatic rehabilitation Other: Land based physical activities Other: Conventional rehabilitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Interest of Hydrophysiotherapy Care in Parkinson Disease's Non-motor Symptoms
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : August 30, 2021
Estimated Study Completion Date : October 30, 2021

Resource links provided by the National Library of Medicine


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 Name: Hydrophysiotherapy

Experimental: Land based physical activities Other: Land based physical activities
Rehabilitation sessions on treadmill will occur at 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.

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.




Primary Outcome Measures :
  1. Change of score on PDQ 39 after reeducation [ Time Frame: Day 1, day 28 (+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


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. NMS Quest score [ Time Frame: Day 1, day 28 (+7), day 56 (+/-7) ]
    Questionnaire score for NMS (non motor signs) in its globality.

  4. 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).

  5. 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)

  6. 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)

  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).

  8. 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)

  9. 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).

  10. 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.

  11. Time for TUG [ Time Frame: Day 1, day 28 (+7), day 56 (+/-7) ]
    Timed Up and Go

  12. Distance of walking [ Time Frame: Day 1, day 28 (+7), day 56 (+/-7) ]
    Distance walked during the 6 min walk test

  13. Walking velocity [ Time Frame: Day 1, day 28 (+7), day 56 (+/-7) ]
    Mean velocity during the 6 min walk test.

  14. Step high [ Time Frame: Day 1, day 28 (+7), day 56 (+/-7) ]
    Mean step high during the 6 min walk test.

  15. Step length [ Time Frame: Day 1, day 28 (+7), day 56 (+/-7) ]
    Mean step length during the 6 min walk test.

  16. Step width [ Time Frame: Day 1, day 28 (+7), day 56 (+/-7) ]
    Mean step width during the 6 min walk test.

  17. Subjective effort [ Time Frame: Day 1, day 28 (+7), day 56 (+/-7) ]
    RPE (Ratio of Perceived Exertion) score, evaluated by Borg Scale (according to the 6 min walk test). Score is between 6 and 20, 6 being a better outcome.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT03960931     History of Changes
Other Study ID Numbers: 2019-A00753-54
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Central Hospital, Nancy, France:
Parkinson's disease
Non motor signs
Postural control
Gait
Hydrophysiotherapy

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases