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

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

— THERMAPARK  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03960931
• Other study ID #: 2019-A00753-54
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: November 30, 2021

Study information

• Verified date: June 2019
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 126
• Est. completion date: November 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France	Institut Régional de Médecine Physique et de Réadaptation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	Non-Motors Signs (NMS) Questionnaire score	Questionnaire score for NMS (non motor signs) in its globality.	Day 1, day 28 (+7), day 56 (+/-7)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Ratio of sensory inputs.	Ratio of sensory inputs in postural control (somatosensory, visual and vestibular ratios).	Day 1, day 28 (+7), day 56 (+/-7)
Secondary	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)
Secondary	Time for Time Up and Go (TUG)	Timed Up and Go	Day 1, day 28 (+7), day 56 (+/-7)
Secondary	Distance of walking	Distance walked during the 6 min walk test	Day 1, day 28 (+7), day 56 (+/-7)
Secondary	Walking velocity	Mean velocity during the 6 min walk test.	Day 1, day 28 (+7), day 56 (+/-7)
Secondary	Step high	Mean step high during the 6 min walk test.	Day 1, day 28 (+7), day 56 (+/-7)
Secondary	Step length	Mean step length during the 6 min walk test.	Day 1, day 28 (+7), day 56 (+/-7)
Secondary	Step width	Mean step width during the 6 min walk test.	Day 1, day 28 (+7), day 56 (+/-7)
Secondary	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)