Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000716066
Ethics application status
Approved
Date submitted
12/02/2010
Date registered
30/08/2010
Date last updated
30/08/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of an enhanced multidisciplinary community based group program for Parkinson's disease.
Scientific title
Does an enhanced multidisciplinary group program incorporating cognitive and speech activities with exercise improve quality of life and cognitive ability in individuals with a diagnosis of Ideopathic Parkinson's disease (residing within the Metro South Health Service District) more than a traditional exercise only program.
Secondary ID [1] 1443 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ideopathic Parkinson's Disease 256811 0
Condition category
Condition code
Neurological 256961 256961 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention program - Group program, 4 weeks duration, with two sessions (2 hours) each week. Program is conducted by trained Physiotherapist, Occupational Therapist and/or Speech Pathologist. Program consists of physical therapy exercise program, cognitive and speech activities. Physical therapy exercise program consists of activities aimed to improve balance and mobility, cardiovascular function, upper limb strength and coordination. Cognitive element focuses on executive functioning, attention, memory and visuospatial skills. Speech element consits of activities aimed at improving breath support and speech clarity. Education is based on self management principles.
Comparative group receives physical therapy exercise program.
Intervention code [1] 256018 0
Rehabilitation
Comparator / control treatment
Physical therapy exercise program - 4 weeks duration, with two sessions each week (as per intervention program).
Control group
Active

Outcomes
Primary outcome [1] 257843 0
Health related quality of life - Parkinson's Disease Questionnaire (PDQ-39)
Timepoint [1] 257843 0
Baseline (triage), pre-intervention, post-intervention, three follow-up re-assessments at 6 weekly intervals.
Primary outcome [2] 257844 0
Montreal Cognitive Assessment (MoCA) - cognition
Timepoint [2] 257844 0
Baseline (triage), pre-intervention, post-intervention, three follow-up re-assessments at 6 weekly intervals.
Secondary outcome [1] 263263 0
Timed up and go
Timepoint [1] 263263 0
Pre-intervention, post-intervention, three follow-up re-assessments at 6 weekly intervals.
Secondary outcome [2] 263264 0
Timed up and go (cognitive)
Timepoint [2] 263264 0
Pre-intervention, post-intervention, three follow-up re-assessments at 6 weekly intervals.
Secondary outcome [3] 263265 0
Geriatric Depression Scale
Timepoint [3] 263265 0
Pre-intervention, post-intervention, three follow-up re-assessments at 6 weekly intervals.
Secondary outcome [4] 263266 0
Frenchay Activities Index - measure of instrumental activities of daily living (questionnaire)
Timepoint [4] 263266 0
Pre-intervention, post-intervention, three follow-up re-assessments at 6 weekly intervals.
Secondary outcome [5] 263267 0
Sit to stand - Functional quads strength
Timepoint [5] 263267 0
Pre-intervention, post-intervention, three follow-up re-assessments at 6 weekly intervals.
Secondary outcome [6] 263268 0
Step Test
Timepoint [6] 263268 0
Pre-intervention, post-intervention, three follow-up re-assessments at 6 weekly intervals.
Secondary outcome [7] 263269 0
External Perturbation Test
Timepoint [7] 263269 0
Pre-intervention, post-intervention, three follow-up re-assessments at 6 weekly intervals.
Secondary outcome [8] 263270 0
9 Hole Peg Test - timed test of fine motor coordination
Timepoint [8] 263270 0
Pre-intervention, post-intervention, three follow-up re-assessments at 6 weekly intervals.
Secondary outcome [9] 263271 0
Voice Handicap Index - questionnaire
Timepoint [9] 263271 0
Pre-intervention, post-intervention, three follow-up re-assessments at 6 weekly intervals.
Secondary outcome [10] 263272 0
Caregiver Strain Index
Timepoint [10] 263272 0
Pre-intervention, post-intervention, three follow-up re-assessments at 6 weekly intervals.

Eligibility
Key inclusion criteria
Clinical diagnosis of Ideopathic Parkinson's Disease
Hoehn and Yahr Score I-III
Medical clearance from primary care physician
Assessed by Occupational Therapist or Physiotherapist as able to fully participate in rehabilitation program
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Able to independently ambulate (with or without aid)

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)
Neurologists that provide services to Parkinson's disease client's residing within the Metro South Community Health District will be invited to refer community dwelling individuals with a diagnosis of Ideopathic Parkinson's disease. Following receipt of referral, staff from the Community Rehabilitation Service (CRS) will contact client to arrange initial assessment.

A joint home based interview by either an Occupational Therapist and Physiotherapist or Speech Pathologist will determine whether the subject meets the inclusion/exclusion criteria. Consent for participation in the study will be obtained. Subjects will be informed that they will be randomly assigned to one of two groups.
Randomisation sequence will be conceled with opaque envelopes until allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer randomisation program will generate sequence.
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
2/11/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256515 0
Self funded/Unfunded
Name [1] 256515 0
Country [1] 256515 0
Primary sponsor type
Government body
Name
Community Rehabilitation Service
Address
Community and Primary Health Services
Metro South Health Service District
Community Rehabilitation Service
660 Kessels Rd
UPPER MT. GRAVATT QLD 4122
Country
Australia
Secondary sponsor category [1] 255824 0
University
Name [1] 255824 0
Griffith University - Primary Health Care Research, Education and Development (PHCRED) fellowship program
Address [1] 255824 0
School of Medicine
Griffith University
University Drive
Meadowbrook
QLD 4131
Country [1] 255824 0
Australia
Other collaborator category [1] 1119 0
Individual
Name [1] 1119 0
Dr Sandy Brauer
Address [1] 1119 0
University of Queensland
St. Lucia QLD 4067
Country [1] 1119 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258560 0
Human Research Ethics Committee, Princess Alexandra Hospital Health Service District
Ethics committee address [1] 258560 0
Ethics committee country [1] 258560 0
Australia
Date submitted for ethics approval [1] 258560 0
Approval date [1] 258560 0
11/05/2009
Ethics approval number [1] 258560 0
2009/082
Ethics committee name [2] 258561 0
Griffith University Human Research Ethics Committee
Ethics committee address [2] 258561 0
Ethics committee country [2] 258561 0
Australia
Date submitted for ethics approval [2] 258561 0
Approval date [2] 258561 0
26/10/2009
Ethics approval number [2] 258561 0
MED/07/09/HREC

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30842 0
Address 30842 0
Country 30842 0
Phone 30842 0
Fax 30842 0
Email 30842 0
Contact person for public queries
Name 14089 0
Michelle Currin
Address 14089 0
Community Rehabilitation Service
Community and Primary Health Services
Metro South Health Service District
Locked Bag 2
ARCHERFIELD QLD 4108
Country 14089 0
Australia
Phone 14089 0
+61 7 3308 6515
Fax 14089 0
Email 14089 0
[email protected]
Contact person for scientific queries
Name 5017 0
Catherine Peters
Address 5017 0
Community Rehabilitation Service
Community and Primary Health Services
Metro South Health Service District
Locked Bag 2
ARCHERFIELD QLD 4108
Country 5017 0
Australia
Phone 5017 0
+61 7 3308 6515
Fax 5017 0
Email 5017 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.