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

NCT ID: NCT03960931

Last Updated: 2019-06-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2021-11-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Aquatic rehabilitation

Group Type: EXPERIMENTAL

Aquatic rehabilitation

Intervention Type: OTHER

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

Group Type: EXPERIMENTAL

Land based physical activities

Intervention Type: OTHER

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

Group Type: OTHER

Conventional rehabilitation

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Hydrophysiotherapy

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Régional de Médecine Physique et de Réadaptation

UNKNOWN

Sponsor Role: collaborator

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

Reference Type: DERIVED

PMID: 38588457 (View on PubMed)

Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

Reference Type: DERIVED

PMID: 36602886 (View on PubMed)

Other Identifiers

2019-A00753-54

Identifier Type: -

Identifier Source: org_study_id