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Trial registered on ANZCTR


Registration number
ACTRN12616000834459
Ethics application status
Approved
Date submitted
21/06/2016
Date registered
24/06/2016
Date last updated
8/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Falls and Balance in Parkinson's Disease (PD): Comparing Land Based vs Traditional Aquatic and Novel Aquatic Physiotherapy
Scientific title
The effects on balance and falls in those with Parkinson's Disease: A comparison between land based, traditional aquatic and novel aquatic physiotherapy "
Secondary ID [1] 289514 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 299218 0
Condition category
Condition code
Neurological 299226 299226 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventions will be 60mins long, once a week for 12 weeks.
A physiotherapist with specialist knowledge of PD (>6yrs) will run the class in the pool whilst an AHA will be poolside to supervise and monitor.
The classes will contain 6 participants only at a time due to safety issues and will be onsite.
At all times the participants are advised to exercise between 3-4 on the BORG scale.

Intervention 1: Traditional aquatic physiotherapy (general strength/ balance/ cardio)
-Walking (Deep)
*High knee (increased hip flexion
*big arms

(Shallow)
*Long steps
*Side steps
*Walking backwards

Step ups
*Front
*Side
*Over
Single leg Squats
Single leg Calf Raises

Change in direction/side step to stop
SLS balance with duel tasking or cognitive tasks (counting, spelling games, carrying tray, pretending to put on clothes with rings through legs)
Kickboard push downs

Standing Tsp rotation and LF
Shoulder extension holding onto rail
High intensity as able
Aim for > or = 15 RPE – monitor for each activity and record
*Flipper kick in sitting
*Jogging/hopping and punching (forward or on the spot)
*Cycling supine
Hydrotones

Intervention 2: Novel aquatic physiotherapy (rotational practice and core exercises)
Supine relaxation in corner
Forwards/ sideways
Reverse crunches off plinth
Supine-box sit-prone (transverse rotation)
Side flexion (saggital rotation)
180 degrees turns, supine-prone-supine (longitudinal rotation)
Intervention code [1] 295106 0
Rehabilitation
Comparator / control treatment
Land Based physiotherapy group
The group will be 60mins long, once a week for 12 weeks.
A physiotherapist with specialist knowledge of PD (>6yrs) will run the class with an AHA.
At all times the participants are advised to exercise between 3-4 on the BORG scale.
The classes will contain 6 participants only at a time due to safety issues and will be onsite.

Exercises:
Gentle UL and LL exercises
Nil UL support
Weighted vest if able
Punching standing bag with stepping forwards/ sideways
Upright bike
Resistance as able
Trunk rotation on foam
Cone touches on/ off foam
Rockerboard or wobbleboard
Mini Stepper machine
Gentle UL and LL stretches
Control group
Active

Outcomes
Primary outcome [1] 298709 0
Feasibility – assessed via Attrition (review of study records), Adherence (review of attendance log), Adverse events (during or after therapy sessions- logged in paperwork and via VHIMS Peninsula Health incident log). Possible adverse events may include dizziness due to low BP, reaction to chlorine- skin rashes, falls risk during transfers from change rooms to pool and vice versa. We will rely on patient self reporting skin rashes, any dizziness will be addressed via the medical team and falls risk will be minimal as the AHA poolside will walk close to patients during transfers.
Timepoint [1] 298709 0
Adverse events will be recorded during the 12 week intervention period and attrition/ adherence will be collated at the end of the 12 weeks.
Primary outcome [2] 298710 0
Balance assessed via the Berg Balance Scale (BBS)
Timepoint [2] 298710 0
After 12 weeks of intervention
Primary outcome [3] 298711 0
Balance will be assessed via the Mini BEST test
Timepoint [3] 298711 0
After 12 mweeks of intervention
Secondary outcome [1] 325030 0
Motor function assessed with the Unified Parkinson's Disease Rating Scale (UPDRS) part 3- motor subscale
Timepoint [1] 325030 0
After 12 weeks of intervention
Secondary outcome [2] 325031 0
Disease specific health related quality of life will be assessed with the Parkinson’s Disease Questionnaire 39 (PDQ-39).
Timepoint [2] 325031 0
After 12 weeks of intervention
Secondary outcome [3] 325032 0
Health related quality of life assessed via the Personal Wellbeing Index-Adult (PWI)
Timepoint [3] 325032 0
After 12 weeks of intervention
Secondary outcome [4] 325033 0
Falls specific confidence assessed via the Falls Efficacy Scale
Timepoint [4] 325033 0
After 12 weeks of intervention
Secondary outcome [5] 325041 0
Satisfaction regarding aquatic physiotherapy treatment
Timepoint [5] 325041 0
At a optional focus group 3 months post end of intervention

Eligibility
Key inclusion criteria
A total of 36 participants (12 in each group) with a confirmed diagnosis of Parkinson’s Disease will be admitted into the program, with no self-reported history of any musculoskeletal, cardiothoracic, other neurological or psychological condition that might potentially affect their therapy. Patients must be medically stable to participate. If there is any doubt to medical stability, the patient’s GP must sign a medical assessment form deeming the patient suitable for hydrotherapy and land based physiotherapy.
Patients must not be currently attending the aquatic or land physiotherapy groups at Peninsula Health and must be happy to participate in any treatment group as allocation is randomised.
Patients must have be able to walk unaided +/- gait aid, have an MMSE (mini mental state exam) score of more than 24 to show sufficient cognition for informed consent.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
MMSE <24/30, unable to walk unaided, contraindications for aquatic physiotherapy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
If they are suitable for the study, they will then be randomly allocated into either the land based , traditional aquatic or novel aquatic physiotherapy groups via sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Analysis will be performed through the RevMan/ SPSS statistical packages. A range of descriptive statistics will be applied to data to describe the participants. Additional parametric and non-parametric statistical methods will be used to explore the differences between groups.
Sample size calculations via Priori calculations yielded a number of over 100 participants, which was deemed unachievable. As this study is a feasibility study, it was discussed and agreed that 12 participants per intervention type would be most appropriate.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6008 0
Golf Links Road Rehabilitation Centre - Frankston
Recruitment postcode(s) [1] 13430 0
3199 - Frankston

Funding & Sponsors
Funding source category [1] 293887 0
Self funded/Unfunded
Name [1] 293887 0
no funding
Address [1] 293887 0
no funding
Country [1] 293887 0
Primary sponsor type
Government body
Name
Peninsula Health
Address
125 Golf Links Rd,
Frankston,
Vic, 3199
Country
Australia
Secondary sponsor category [1] 292713 0
University
Name [1] 292713 0
Monash University
Address [1] 292713 0
Peninsula Campus,
McMahons Rd,
Frankston,
Vic, 3199
Country [1] 292713 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295304 0
Peninsula Health Human Research Ethics Committee
Ethics committee address [1] 295304 0
2 Hastings Rd,
Frankston,
Vic, 3199
Ethics committee country [1] 295304 0
Australia
Date submitted for ethics approval [1] 295304 0
08/03/2016
Approval date [1] 295304 0
30/03/2016
Ethics approval number [1] 295304 0
HREC/15/PH/3
Ethics committee name [2] 295305 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [2] 295305 0
Peninsula Campus,
McMahons Rd,
Frankston,
Vic, 3199
Ethics committee country [2] 295305 0
Australia
Date submitted for ethics approval [2] 295305 0
26/04/2016
Approval date [2] 295305 0
28/04/2016
Ethics approval number [2] 295305 0
CF16/1341 - 2016000731

Summary
Brief summary
The purpose of this research is to determine if there are changes in your function (for example balance and falling) after completing different aquatic (pool) or land exercises. It is also going to increase the understanding of how people feel about aquatic (pool) and land physiotherapy.
One pool group will complete exercises such as stretching, cardiac and general strengthening exercises whilst the other pool group will practise core exercises such as floating, rolling and other specific exercises. The land based exercise group will complete stretching, balance, strengthening and aerobic exercises.
Participants will be asked to attend a 1hr class once a week for 12 weeks and will be invited to attend a focus group 3 months after finishing the trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66826 0
Miss Aan Fleur Terrens
Address 66826 0
Movement Disorder Program,
Peninsula Health,
Building 2, 125 Golf Links Rd,
Frankston,
Vic, 3199
Country 66826 0
Australia
Phone 66826 0
+613 9784 8630
Fax 66826 0
Email 66826 0
fterrens@phcn.vic.gov.au
Contact person for public queries
Name 66827 0
Miss Fleur Terrens
Address 66827 0
Movement Disorder Program,
Peninsula Health
Building 2, 125 Golf Links Rd,
Frankston,
Vic, 3199
Country 66827 0
Australia
Phone 66827 0
+613 9784 8630
Fax 66827 0
Email 66827 0
fterrens@phcn.vic.gov.au
Contact person for scientific queries
Name 66828 0
Ms Fleur Terrens
Address 66828 0
Movement Disorder Program,
Peninsula Health,
Building 2, 125 Golf Links Rd,
Frankston,
Vic, 3199
Country 66828 0
Australia
Phone 66828 0
+613 9784 8630
Fax 66828 0
Email 66828 0
fterrens@phcn.vic.gov.au

No information has been provided regarding IPD availability
Summary results
No Results