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

C

Central Hospital, Nancy, France

Status

Unknown

Conditions

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

Treatments

Other: Land based physical activities
Other: Conventional rehabilitation
Other: Aquatic rehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT03960931
2019-A00753-54

Details and patient eligibility

About

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.

Enrollment

126 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

126 participants in 3 patient groups

Aquatic rehabilitation
Experimental group
Treatment:
Other: Aquatic rehabilitation
Land based physical activities
Experimental group
Treatment:
Other: Land based physical activities
Conventional rehabilitation
Other group
Treatment:
Other: Conventional rehabilitation

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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