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

Primary Purpose

Parkinson Disease, Rehabilitation

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Stand-Up Paddle Rehabilitation
Physiotherapy Rehabilitation
Sponsored by
FLABEAU Olivier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Parkinson Disease focused on measuring Parkinson's Disease, Rehabilitation, Balance, Aquatic therapy, Stand Up Paddle

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CH Côte Basque

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aqua SUP

Physiotherapy

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Movement Disorder Society - Unified Parkinson's Disease rating Scale III score variation
Movement Disorder Society - Unified Parkinson's Disease rating Scale III : Motor symptoms evaluation, 18 items quoted 0 (normal) to 4 (severe). Total score recorded : minimum =0 Maximum =72. Higher values represent a worse outcome
Berg Balance Scale score variation
Berg Balance Scale test : Balance and posture evaluation, 14 items quoted 0(normal) to 3 (severe). Total score recorded : Minimum=0 Maximum = 42. Higher values represent a worse outcome
Mini-Mental State Examination score variation
Mini-Mental State Examination test : Cognitice capacity evaluation, 6 items evaluated. Total score recorded : Minimum = 0 Maximum = 30 . Higher values represent a better outcome
Modified Timed Up and Go score variation
Modified Timed Up and Go Test : Functionnal capacity evaluation, Timing Walking test. Higher values represent a worse outcome
Global Mobility Task score variation
Global Mobility Task Test : Functionnal capacity evaluation; 5 items quoted 0(normal) to 4 (severe). Total score recorded : Minimum=0 Maximum = 20. Higher values represent a worse outcome
2 minutes walking test score variation
2 minutes walking test : Timing Walking test. Higher values represent a better outcome
Posturographic data (Satel Platform) variation
Posturographic data test : Statokinesigram and stabilogram
Temporo-spatial parameters of gait (GAITRite walkway system) variation
Temporo-spatial parameters of GAITRite walkway system test : Walking test : lengh, timing and speed recorded. Higher values represent a better outcome for speed and lengh
Parkinson's Disease Questionnaire 39-item score variation
Parkinson's Disease Questionnaire 39-item test : Quality of life evaluation; 39 items quoted "never" "rarely" "sometimes" "often" or "always".
Beck Depression Inventory score variation
Beck Depression Inventory test : depression evaluation . 21 items quoted 0(normal) to 3 (severe). Total score recorded : Minimum=0 Maximum = 63. Higher values represent a worse outcome
Clinical Global Impression (CGI) score variation
Clinical Global Impression test : Global improvement evaluation : 1 item quoted 1 (very high improvement) to 7 (very high worsening). Higher value represent a worse outcome
Isokinetic lower-limb muscle strength results variation
Isokinetic lower-limb muscle strength test : muscular strenght evaluation. Right anf left quadriceps and harmstrings strenght evaluation. Higher values represent a better outcome
Maximal oxygen uptake (V02max) results variation
Maximal oxygen uptake test : cardio-respiratory capacity evaluation. Higher value represent a better outcome

Full Information

First Posted
June 26, 2018
Last Updated
April 7, 2023
Sponsor
FLABEAU Olivier
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1. Study Identification

Unique Protocol Identification Number
NCT03582371
Brief Title
Aqua Stand-Up Paddle Balance Effect in Parkinson's Disease (AquaSUP PARK)
Acronym
AquaSUP PARK
Official Title
Effect of an Aqua Stand-Up Paddle Program on Postural Instability in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 18, 2018 (Actual)
Primary Completion Date
September 8, 2022 (Actual)
Study Completion Date
September 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
FLABEAU Olivier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Rehabilitation
Keywords
Parkinson's Disease, Rehabilitation, Balance, Aquatic therapy, Stand Up Paddle

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Proof of concept. Study of non-inferiority, prospective, monocentric, randomized, controlled (Aqua SUP vs physiotherapy), in blind treatment compared to applied treatment.
Masking
Outcomes Assessor
Masking Description
Patients will be scored Mini-Balance evaluation System Test by blinded investigators, before and after AquaSup or Physiotherapy
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aqua SUP
Arm Type
Experimental
Arm Description
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.
Arm Title
Physiotherapy
Arm Type
Active Comparator
Arm Description
Patients in the control group will receive a conventional physiotherapy session of 1 hour, twice a week, for 8 weeks.
Intervention Type
Procedure
Intervention Name(s)
Stand-Up Paddle Rehabilitation
Intervention Description
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
Intervention Name(s)
Physiotherapy Rehabilitation
Intervention Description
Patients in the control group will receive a conventional physiotherapy session of 1 hour, twice a week, for 8 weeks.
Primary Outcome Measure Information:
Title
Mini-Balance Evaluation System Score variation
Description
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
Time Frame
Change from baseline Mini-Balance Evaluation Systems Test at 2 months.
Secondary Outcome Measure Information:
Title
Movement Disorder Society - Unified Parkinson's Disease rating Scale III score variation
Description
Movement Disorder Society - Unified Parkinson's Disease rating Scale III : Motor symptoms evaluation, 18 items quoted 0 (normal) to 4 (severe). Total score recorded : minimum =0 Maximum =72. Higher values represent a worse outcome
Time Frame
Change from baseline Movement Disorder Society - Unified Parkinson's Disease rating Scale III at 2 months
Title
Berg Balance Scale score variation
Description
Berg Balance Scale test : Balance and posture evaluation, 14 items quoted 0(normal) to 3 (severe). Total score recorded : Minimum=0 Maximum = 42. Higher values represent a worse outcome
Time Frame
Change from baseline Berg Balance Scale at 2 months
Title
Mini-Mental State Examination score variation
Description
Mini-Mental State Examination test : Cognitice capacity evaluation, 6 items evaluated. Total score recorded : Minimum = 0 Maximum = 30 . Higher values represent a better outcome
Time Frame
Change from baseline Mini-Mental State Examination: at 2 months
Title
Modified Timed Up and Go score variation
Description
Modified Timed Up and Go Test : Functionnal capacity evaluation, Timing Walking test. Higher values represent a worse outcome
Time Frame
Change from baseline Modified Modified Timed Up and Go at 2 months
Title
Global Mobility Task score variation
Description
Global Mobility Task Test : Functionnal capacity evaluation; 5 items quoted 0(normal) to 4 (severe). Total score recorded : Minimum=0 Maximum = 20. Higher values represent a worse outcome
Time Frame
Change from baseline Global Mobility Task at 2 months
Title
2 minutes walking test score variation
Description
2 minutes walking test : Timing Walking test. Higher values represent a better outcome
Time Frame
Change from baseline 2 minutes walking test 2 months
Title
Posturographic data (Satel Platform) variation
Description
Posturographic data test : Statokinesigram and stabilogram
Time Frame
Change from baseline Posturographic data at 2 months
Title
Temporo-spatial parameters of gait (GAITRite walkway system) variation
Description
Temporo-spatial parameters of GAITRite walkway system test : Walking test : lengh, timing and speed recorded. Higher values represent a better outcome for speed and lengh
Time Frame
Change from baseline Temporo-spatial parameters of GAITRite walkway system at 2 months
Title
Parkinson's Disease Questionnaire 39-item score variation
Description
Parkinson's Disease Questionnaire 39-item test : Quality of life evaluation; 39 items quoted "never" "rarely" "sometimes" "often" or "always".
Time Frame
Change from baseline Parkinson's Disease Questionnaire 39-item at 2 months
Title
Beck Depression Inventory score variation
Description
Beck Depression Inventory test : depression evaluation . 21 items quoted 0(normal) to 3 (severe). Total score recorded : Minimum=0 Maximum = 63. Higher values represent a worse outcome
Time Frame
Change from baseline Beck Depression Inventory at 2 months
Title
Clinical Global Impression (CGI) score variation
Description
Clinical Global Impression test : Global improvement evaluation : 1 item quoted 1 (very high improvement) to 7 (very high worsening). Higher value represent a worse outcome
Time Frame
Change from beseline Clinical Global Impression at 2 months
Title
Isokinetic lower-limb muscle strength results variation
Description
Isokinetic lower-limb muscle strength test : muscular strenght evaluation. Right anf left quadriceps and harmstrings strenght evaluation. Higher values represent a better outcome
Time Frame
Change from baseline Isokinetic lower-limb muscle strength at 2 months
Title
Maximal oxygen uptake (V02max) results variation
Description
Maximal oxygen uptake test : cardio-respiratory capacity evaluation. Higher value represent a better outcome
Time Frame
Change from baseline Maximal oxygen uptake at 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
CH Côte Basque
City
Bayonne
ZIP/Postal Code
64109
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD
IPD Sharing Time Frame
End of study :June 2023

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

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