Aqua Stand-Up Paddle Balance Effect in Parkinson's Disease (AquaSUP PARK)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-18

Study Completion Date

2022-09-08

Brief Summary

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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.

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Detailed Description

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Parkinson's disease (PD) is a relentless neurodegenerative disorder leading to functional impairment with postural instability. Postural instability is associated with an increased risk of falling and a decreased quality of life, and levodopa therapy may only have little effect on balance. Evidence supports physiotherapy and physical activity as an alternative treatment for postural instability in PD. Several types of physical activity have been tested in PD which target different specificities of rehabilitation such as stretching, muscle strengthening, balance, occupational therapy, cueing, treadmill training, with contrasting data regarding postural instability. The investigators want to develop an innovative physical activity with specific focus on the management of the postural instability in PD patients. Stand-up Paddle (SUP) is an aquatic sport improving postural instability in sedentary people that may be practiced in a swimming pool with static conditions for safety (Aqua SUP).

In order to assess the effect on postural instability, PD patients with baseline postural instability will be scored by Mini-Balance Evaluation Systems Test (miniBESTest) before and after 8 weeks of Aqua SUP practice and compared to physiotherapy according to a randomized controlled trial with non-inferiority design.

Patients will be clinically assessed at baseline regarding the primary outcome miniBESTest and secondary outcome measures. A secondary visit will take place at 2 months after inclusion (Aqua SUP versus physiotherapy). A tertiary visit will be completed at 6 months after inclusion to assess long term effects.

Conditions

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Parkinson Disease Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Proof of concept. Study of non-inferiority, prospective, monocentric, randomized, controlled (Aqua SUP vs physiotherapy), in blind treatment compared to applied treatment.

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Patients will be scored Mini-Balance evaluation System Test by blinded investigators, before and after AquaSup or Physiotherapy

Study Groups

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Aqua SUP

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.

Group Type EXPERIMENTAL

Stand-Up Paddle Rehabilitation

Intervention Type PROCEDURE

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.

Physiotherapy

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

Group Type ACTIVE_COMPARATOR

Physiotherapy Rehabilitation

Intervention Type PROCEDURE

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

Interventions

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Stand-Up Paddle Rehabilitation

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.

Intervention Type PROCEDURE

Physiotherapy Rehabilitation

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No