Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000390381
Ethics application status
Approved
Date submitted
23/07/2008
Date registered
4/08/2008
Date last updated
23/05/2023
Date data sharing statement initially provided
23/05/2023
Date results provided
23/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Home based rehabilitation to reduce falls and disability in Parkinson's disease (PD)
Scientific title
Home based rehabilitation to reduce falls in people with Parkinson's disease (PD): a randomised controlled trial.
Secondary ID [1] 289476 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 3453 0
Condition category
Condition code
Neurological 3611 3611 0 0
Parkinson's disease
Physical Medicine / Rehabilitation 3612 3612 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will participate in a 6 week home-based rehabilitation program comprising a once weekly 60 minute individual program delivered by a trained therapist, together with a once weekly 60 minute self-directed home exercise program. The intervention is designed to provide particpants with an integrated "package" of evidence based therapy, including movement strategy training, strengthening (progressive resisted exercise) and falls education.
At the initial home visit, the therapist will conduct a once-off environmental analysis, observe functional mobility and performance of activities of daily living within the participant's home environment in order to identify any falls risk factors that may be present. This assessment will take approximately 20 minutes and the information obtained will allow the therapist to tailor the falls education component of the home based rehabilitation program to the individual participant's needs. The falls prevention education component of the intervention will be provided to the participant and their care-giver during each of the weekly home visits.
Intervention code [1] 295058 0
Rehabilitation
Intervention code [2] 295059 0
Rehabilitation
Comparator / control treatment
The control group will participate in a 6 week home-based "life skills" program comprising a once weekly 60 minute individual program delivered by a trained therapist, together with a once weekly self-directed life skills home program. The life skills program is designed to provide education to people with Parkinson's disease, and will cover a range of topics including medication, hand writing, diet, stress management, fatigue management and self-care activities such as grooming and eating. The life skills program will include any content related to falls, physical exercise or gait rehabilitation.
Control group
Active

Outcomes
Primary outcome [1] 4505 0
Falls frequency for the 12 month period immediately following the home-based rehabilitation program. Falls will be recorded on a calendar by each participant and the accuracy of this information will be verified during a phone call from the researchers.
Timepoint [1] 4505 0
The falls calendar will be returned to the researchers monthly for the 12 months following the rehabilitation program.
Secondary outcome [1] 7620 0
Motor disability: Measured on the motor section of the Unified Parkinson's Disease Rating Scale
Timepoint [1] 7620 0
At baseline, 6 weeks (immediately post therapy) and 12 months post therapy.
Secondary outcome [2] 7621 0
Global disability: Measured as the total score on the Unified Parkinson's Disease Rating Scale
Timepoint [2] 7621 0
At baseline, 6 weeks (immediately post therapy) and 12 months post therapy.
Secondary outcome [3] 7622 0
Quality of Life: Measured by the PDQ39 (Parkinson's Disease Questionnaire) and the EuroQol-5D
Timepoint [3] 7622 0
At baseline, 6 weeks (immediately post therapy) and 12 months post therapy.
Secondary outcome [4] 7623 0
Economic data: Medicare and hospitalisation costs over the 12 month study period
Timepoint [4] 7623 0
12 months post therapy

Eligibility
Key inclusion criteria
1. Diagnosis of idiopathic Parkinson's disease (confirmed by a neurologist)
2. Living in the community
3. Classified on the Hoehn & Yahr scale as stage I-IV
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Suffer from a cardiopulmonary, musculoskeletal, endocrine or other medical condition that prevents safe participation in a home exercise program (as determined by the referring neurologist or medical practitioner)
(3) Participant or their care-giver/ family are unwilling to have therapy and assessments in their home
(4) Unable to communicate in English (interpreters are not available)
(5) Have dementia, score < 24 on the Mini Mental State Examination or are unable to provide informed consent

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)
Participants may be recruited from a variety of sources; however the primary source will be referral from 3 neurologists who are associated inevstigators in the trial.
Each participant will be required to have an initial screening by one of the researchers to ensure they meet the eligibility criteria. Participants are then asked to sign a form to provide consent for the researchers to contact the treating neurologist or GP to confirm the diagnosis of Parkinson disease and safety for participation in the exercise program.
Randomised group allocation for each participant will be performed by an independent researcher from a different organisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be stratified; participants recruited by each neurologist will be randomised separately into control or experimental groups. Concealed randomisation will be prepared using a computer generated random number sequence. Random permuted blocks will be used to ensure that after every block of participants the control and experimental groups have equal numbers. Those involved in recruitment will be blinded to the random 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
Completed
Date of first participant enrolment
Anticipated
1/04/2009
Actual
7/04/2009
Date of last participant enrolment
Anticipated
20/12/2011
Actual
28/12/2011
Date of last data collection
Anticipated
Actual
1/02/2012
Sample size
Target
180
Accrual to date
Final
143
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 3634 0
Government body
Name [1] 3634 0
National Health and Medical Research Council
Country [1] 3634 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Centre for Health Exercise and Sports Medicine
School of Physiotherapy
The University of Melbourne
Victoria 3010
Country
Australia
Secondary sponsor category [1] 3268 0
University
Name [1] 3268 0
La Trobe University
Address [1] 3268 0
Bundoora, Victoria
Country [1] 3268 0
Australia
Other collaborator category [1] 338 0
University
Name [1] 338 0
La Trobe University
Address [1] 338 0
School of Physiotherapy
La Trobe University
Bunddora
Victoria 3086
Country [1] 338 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5689 0
The University of Melbourne
Ethics committee address [1] 5689 0
Ethics committee country [1] 5689 0
Australia
Date submitted for ethics approval [1] 5689 0
Approval date [1] 5689 0
05/05/2008
Ethics approval number [1] 5689 0
HREC 0824406

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

Contacts
Principal investigator
Name 28775 0
Prof Meg E. Morris
Address 28775 0
School Allied Health, Level 5 HS3
La Trobe University
Plenty Road
Bundoora
3086
Victoria
Australia
Country 28775 0
Australia
Phone 28775 0
+61394791111
Fax 28775 0
+61394677186
Email 28775 0
[email protected];[email protected]
Contact person for public queries
Name 11932 0
Meg Morris
Address 11932 0
School Allied Health, Level 5 HS3
La Trobe University
Plenty Road
Bundoora
3086
Victoria
Country 11932 0
Australia
Phone 11932 0
+61394680100
Fax 11932 0
+61394677186
Email 11932 0
[email protected]
Contact person for scientific queries
Name 2860 0
Professor Meg Morris
Address 2860 0
School Allied Health, Level 5 HS3
La Trobe University
Plenty Road
Bundoora
3086
Victoria
Country 2860 0
Australia
Phone 2860 0
+61 3 94680100
Fax 2860 0
+6194677186
Email 2860 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not in original ethics application


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.