NCT03960931

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2019

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 23, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

June 25, 2019

Status Verified

June 1, 2019

Enrollment Period

2.3 years

First QC Date

April 12, 2019

Last Update Submit

June 21, 2019

Conditions

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

Keywords

Parkinson's diseaseNon motor signsPostural controlGaitHydrophysiotherapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (17)

  • Persistence of change of score on PDQ 39 after reeducation

    Day 28(+7), day 56 (+/-7)

  • PDQ 39 sub-scores

    Day 1, day 28 (+7), day 56 (+/-7)

  • Non-Motors Signs (NMS) Questionnaire score

    Day 1, day 28 (+7), day 56 (+/-7)

  • Parkinson Anxiety Scale (PAS) score

    Day 1, day 28 (+7), day 56 (+/-7)

  • Parkinson's Disease specific Pain score

    Day 1, day 28 (+7), day 56 (+/-7)

  • +12 more secondary outcomes

Study Arms (3)

Aquatic rehabilitation

EXPERIMENTAL
Other: Aquatic rehabilitation

Land based physical activities

EXPERIMENTAL
Other: Land based physical activities

Conventional rehabilitation

OTHER
Other: Conventional rehabilitation

Interventions

Aquatic rehabilitationOTHER

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.

Also known as: Hydrophysiotherapy
Aquatic rehabilitation
Land based physical activitiesOTHER

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.

Land based physical activities
Conventional rehabilitationOTHER

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.

Conventional rehabilitation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 38588457DERIVED

  • 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.

    PMID: 36602886DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2019

First Posted

May 23, 2019

Study Start

July 1, 2019

Primary Completion

September 30, 2021

Study Completion

November 30, 2021

Last Updated

June 25, 2019

Record last verified: 2019-06