Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000900213
Ethics application status
Approved
Date submitted
7/08/2009
Date registered
16/10/2009
Date last updated
16/10/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does Aquatic Physiotherapy improve quality of life, balance and gait in people with early to mid stage Parkinson's Disease?
Scientific title
Comparison of the effects of aquatic physiotherapy with no physiotherapy on quality of life, balance, and gait in people with early to mid stage Parkinson's disease.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 2011 0
Condition category
Condition code
Neurological 2104 2104 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
water based exercises for approx 45 minutes twice a week for 8 weeks; patients standing in chest deep warm water with option of holding on to handrail; exercises directed by trained physiotherapist; stretching exercises for calf, hamstrings, hip flexors; flexibility exercises for spine; range of motion and strengthening exercises for upper and lower limbs; core stability exercises; balance exercises;
Intervention code [1] 1601 0
Treatment: Other
Intervention code [2] 237099 0
Prevention
Comparator / control treatment
The control group will be offered the intervention after 8 weeks following their second assessment.
Control group
Active

Outcomes
Primary outcome [1] 2931 0
Self reported severity of Parkinson's Disease via Parkinson's Disease Questionnaire 39
Timepoint [1] 2931 0
Pre random allocation and 8 weeks later
Primary outcome [2] 2932 0
Timed Up and Go Test to measure gait quality and function
Timepoint [2] 2932 0
Pre random Allocation and 8 weeks later
Primary outcome [3] 2933 0
Functional Reach Test to measure functional balance in standing as leaning forward with outstretched arm at 90 degrees forward flexion alongside a tape measure fixed to wall at appropriate height for patient; distance patient can reach forward without shifting feet or falling measured in centimetres. Assesor standing close by for safety and to record measurement.
Timepoint [3] 2933 0
Pre random allocation and 8 weeks later
Secondary outcome [1] 4968 0
Functional Axial Rotation - this is measured by the assessor with the patient seated in a backless chair placed in the centre of a supported, circular hoop at eyelevel of the patient, patient's feet firmly on floor, arms folded on chest, pelvis lightly fastened to chair by elastic belt to reduce pelvic movement, a headpiece fitted with a "pointer" is fitted to patients head (like you would wear a cap) and patient is asked to turn to look as far around to the right as possible and identify a symbol that they can see on the inside of the hoop. The patient is then asked to do the same to the left. The hoop is marked off at 5 degree intervals for the 360 degree range around the inside of the hoop and thus a measure of functional axial rotation is gained.
Timepoint [1] 4968 0
pre random allocation and 8 weeks later
Secondary outcome [2] 4969 0
Six Minute walk test to measure walking distance/speed /quality and fitness
Timepoint [2] 4969 0
pre random allocation and 8 weeks later

Eligibility
Key inclusion criteria
Idiopathic Parkinson's Disease.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Other neurological, musculoskeletal or cardiopulmonary conditions contra-indicated 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)
eligible participants will be randomly allocated to one of two groups: an aquatic physiotherapy group or a control group. Group allocation will be concealed in numbered, sealed, opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random allocation method used to determine group allocation schedule.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/03/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
84
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2253 0
Charities/Societies/Foundations
Name [1] 2253 0
Uniting Care Bequest Fund
Country [1] 2253 0
Australia
Funding source category [2] 237469 0
Charities/Societies/Foundations
Name [2] 237469 0
Uniting Care Bequest Fund
Country [2] 237469 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Uniting Care
Address
C/O War Memorial Hospital
125 Birrell St Waverley 2024 NSW
Country
Australia
Secondary sponsor category [1] 2036 0
Hospital
Name [1] 2036 0
War Memorial Hopsital
Address [1] 2036 0
125 Birrell St Waverley 2024 NSW
Country [1] 2036 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4083 0
Human Research Ethics Committee - Northern Section South Eastern Sydney Illawarra Area Health Service
Ethics committee address [1] 4083 0
Ethics committee country [1] 4083 0
Australia
Date submitted for ethics approval [1] 4083 0
08/09/2006
Approval date [1] 4083 0
26/09/2006
Ethics approval number [1] 4083 0
1/06/0231

Summary
Brief summary
The efficacy of hydrotherapy to land based therapy in th early to mid stages of Parkinson's disease
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27535 0
Address 27535 0
Country 27535 0
Phone 27535 0
Fax 27535 0
Email 27535 0
Contact person for public queries
Name 10790 0
Vicki Sharrock
Address 10790 0
Physiotherapy Department
War Memorial Hopsital
125 Birrell st
Waverley
Sydney NSW 2024
Country 10790 0
Australia
Phone 10790 0
+61 2 93690221
Fax 10790 0
+61 2 93690452
Email 10790 0
[email protected]
Contact person for scientific queries
Name 1718 0
Vicki Sharrock
Address 1718 0
Physiotherapy Department
War Memorial Hopsital
125 Birrell st
Waverley
Sydney NSW 2024
Country 1718 0
Australia
Phone 1718 0
+61 2 93690221
Fax 1718 0
+61 2 93690452
Email 1718 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.