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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03960931
Acronym
THERMAPARK
Enrollment
126
Registered
2019-05-23
Start date
2019-07-01
Completion date
2021-11-30
Last updated
2019-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

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.

OTHERLand 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.

OTHERConventional 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.

Sponsors

Institut Régional de Médecine Physique et de Réadaptation
CollaboratorUNKNOWN
Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change of score on Parkinson's Disease Questionnaire 39 (PDQ 39) after reeducationDay 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

MeasureTime frameDescription
PDQ 39 sub-scoresDay 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
Non-Motors Signs (NMS) Questionnaire scoreDay 1, day 28 (+7), day 56 (+/-7)Questionnaire score for NMS (non motor signs) in its globality.
Parkinson Anxiety Scale (PAS) scoreDay 1, day 28 (+7), day 56 (+/-7)Parkinson's Anxiety Scale, evaluating anxiety (between 0 and 30, a lower score being a better outcome).
Parkinson's Disease specific Pain scoreDay 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 scoreDay 1, day 28 (+7), day 56 (+/-7)Visual Analogic Scale (VAS) (between 0 and 10, a lower score being a better score)
Mean Equilibrium path lengthDay 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).
Mean Equilibrium ellipse areaDay 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).
Persistence of change of score on PDQ 39 after reeducationDay 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.
Time for Time Up and Go (TUG)Day 1, day 28 (+7), day 56 (+/-7)Timed Up and Go
Distance of walkingDay 1, day 28 (+7), day 56 (+/-7)Distance walked during the 6 min walk test
Walking velocityDay 1, day 28 (+7), day 56 (+/-7)Mean velocity during the 6 min walk test.
Step highDay 1, day 28 (+7), day 56 (+/-7)Mean step high during the 6 min walk test.
Step lengthDay 1, day 28 (+7), day 56 (+/-7)Mean step length during the 6 min walk test.
Step widthDay 1, day 28 (+7), day 56 (+/-7)Mean step width during the 6 min walk test.
Subjective effortDay 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.
EntropyDay 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026