NCT03582371

Brief Summary

Postural instability is associated with falls and a decreased quality of life in Parkinson's disease (PD). Evidence supports physical activity rather than levodopa for postural instability management. Considering the proven effects of the Stand-up Paddle (SUP) activity on postural instability in sedentary people, the investigators wanted to develop this aquatic activity in a swimming pool on static conditions (Aqua SUP) for PD patients. The objective is to assess the postural instability change by measuring the Mini-Balance Evaluation Systems Test (miniBESTest) after 8 weeks of Aqua SUP compared to physiotherapy in PD patients with baseline postural instability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

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

June 26, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 11, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

September 18, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2022

Completed
Last Updated

April 10, 2023

Status Verified

April 1, 2023

Enrollment Period

4 years

First QC Date

June 26, 2018

Last Update Submit

April 7, 2023

Conditions

Parkinson DiseaseRehabilitation

Keywords

Parkinson's DiseaseRehabilitationBalanceAquatic therapyStand Up Paddle

Outcome Measures

Primary Outcomes (1)

  • Mini-Balance Evaluation System Score variation

    Mini-Balance Evaluation System Test : Postural instability with falling risk evaluation, 14 items quoted 0 (severe) to 2 (normal). Total score recorded : minimum =0 Maximum =28. Higher values represent a better outcome

    Change from baseline Mini-Balance Evaluation Systems Test at 2 months.

Secondary Outcomes (13)

  • Movement Disorder Society - Unified Parkinson's Disease rating Scale III score variation

    Change from baseline Movement Disorder Society - Unified Parkinson's Disease rating Scale III at 2 months

  • Berg Balance Scale score variation

    Change from baseline Berg Balance Scale at 2 months

  • Mini-Mental State Examination score variation

    Change from baseline Mini-Mental State Examination: at 2 months

  • Modified Timed Up and Go score variation

    Change from baseline Modified Modified Timed Up and Go at 2 months

  • Global Mobility Task score variation

    Change from baseline Global Mobility Task at 2 months

  • +8 more secondary outcomes

Study Arms (2)

Aqua SUP

EXPERIMENTAL

Patients in the Aqua SUP group will benefit from a 1 hour Aqua SUP session, twice a week, for 8 weeks in a therapeutic pool.

Procedure: Stand-Up Paddle Rehabilitation

Physiotherapy

ACTIVE COMPARATOR

Patients in the control group will receive a conventional physiotherapy session of 1 hour, twice a week, for 8 weeks.

Procedure: Physiotherapy Rehabilitation

Interventions

Stand-Up Paddle RehabilitationPROCEDURE

Patients in the Aqua SUP group will benefit from a 1 hour Aqua SUP session, twice a week, for 8 weeks in a therapeutic pool.

Aqua SUP
Physiotherapy RehabilitationPROCEDURE

Patients in the control group will receive a conventional physiotherapy session of 1 hour, twice a week, for 8 weeks.

Physiotherapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or Female aged 18 to 80 years of age.
  • Patients suffering from idiopathic Parkinson's Disease according to the criteria of the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic.
  • Presence of balance disorder : Stage Hoehn and Yahr 2.5 to 4.
  • Motor level stable, without change of treatment in last 6 weeks
  • Subjects affiliated to a social security scheme or beneficiary of an equivalent scheme
  • Subjects are volunteers with their signed consent

You may not qualify if:

  • Patients suffering from disabling neurological conditions other than IPD. Patients with progressive psychiatric pathologies.
  • Patients with significant cognitive impairment (MMS \<24).
  • Presence of orthopedic problems incompatible with the practice of Aqua SUP.
  • Medical advice against the practice of endurance exercise and muscle building.
  • Patients with history or presence of cardiovascular or respiratory conditions, or patients who answered "yes" to any of the items in the Revised Physical Activity Readiness Questionnaire (Q-AAP).
  • Patients with a condition which is deemed incompatible with the therapeutic pool: uncontrolled vesico-sphincteric disorder, aquaphobia, deterioration of the skin condition (wound, eschar, ulcer).
  • Persons subject to decision making support (eg. legal guardianship or conservator).
  • Patients in the process of participating in another study.
  • Pregnant woman.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CH Côte Basque

Bayonne, 64109, France

Location

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
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Patients will be scored Mini-Balance evaluation System Test by blinded investigators, before and after AquaSup or Physiotherapy
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Proof of concept. Study of non-inferiority, prospective, monocentric, randomized, controlled (Aqua SUP vs physiotherapy), in blind treatment compared to applied treatment.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Hospital practitionner

Study Record Dates

First Submitted

June 26, 2018

First Posted

July 11, 2018

Study Start

September 18, 2018

Primary Completion

September 8, 2022

Study Completion

September 8, 2022

Last Updated

April 10, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share

All IPD

Shared Documents
CSR
Time Frame
End of study :June 2023

Locations

FR(1)