Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000419460
Ethics application status
Approved
Date submitted
14/08/2007
Date registered
20/08/2007
Date last updated
28/11/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of movement rehabilitation compared to exercises in Parkinson disease
Scientific title
Effects of movement rehabilitation compared to exercises for inpatients with idiopathic Parkinson disease
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease. 2254 0
Condition category
Condition code
Physical Medicine / Rehabilitation 2346 2346 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Movement strategies - Participants randomized to the movement strategy training group learned how to use cognitive strategies to enhance walking, turning, standing up from a chair and obstacle negotiation as detailed in the protocol by Morris ME (2000) Physical Therapy 80(6); 578-97. A maximum of 16 sessions of up to 45 minutes of therapy is provided over a two week inpatient period (ie. 1 x 45 minutes session daily for 2 weeks).
Intervention code [1] 1966 0
Rehabilitation
Comparator / control treatment
Exercises - Conventional musculoskeletal exercises aimed to improve strength, range of movement, posture, general fitness and ADL follows Schenkman’s protocol as detailed in Journal of the American Geriatrics Society 1998; 46:1207-1216. A maximum of 16 sessions of up to 45 minutes of therapy is provided over a two week inpatient period.
Control group
Active

Outcomes
Primary outcome [1] 3241 0
Disability - Measured by the United Parkinson's Disease Rating Scale (UPDRS) provides patients self reports of their level of ability for difference functional tasks of everyday living, mobility, cognition and dyskinesia.
Timepoint [1] 3241 0
Measured at 2 weeks after rehabilitation has begun.
Secondary outcome [1] 5408 0
Walking speed - Measured over 10m by a blinded tester using a hand held stop watch.
Timepoint [1] 5408 0
Measured at 2 weeks after rehabilitation has begun.

Eligibility
Key inclusion criteria
Idiopathic Parkinson disease.
Inpatient.
Medically stable.
Minimum age
21 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Score less than 24 on Mini Mental Status Examination.
Hoehn & Yahr Grades 1-4.
Medically unstable.

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)
The person who determined if a subject was eligible for inclusion in the trial was unaware, when this decision was made, to which group the subject would be allocated. Allocation involved the initial contact therapist (hospital based) contacting the holder of the allocation schedule who was "off-site" at a University.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated number sequences.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
28
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 216 0
3192

Funding & Sponsors
Funding source category [1] 2502 0
University
Name [1] 2502 0
Melbourne University
Country [1] 2502 0
Australia
Primary sponsor type
University
Name
Meg Morris
Address
Allied Health Clinical Research Unit
Kingston Centre
Warrigal Rd
Cheltenham VIC 3192
Country
Australia
Secondary sponsor category [1] 2274 0
None
Name [1] 2274 0
Address [1] 2274 0
Country [1] 2274 0
Other collaborator category [1] 3 0
Individual
Name [1] 3 0
Robert Iansek
Address [1] 3 0
Kingston Centre
Cheltenham VIC 3192
Country [1] 3 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4416 0
Southern Health; Epworth.
Ethics committee address [1] 4416 0
Ethics committee country [1] 4416 0
Australia
Date submitted for ethics approval [1] 4416 0
Approval date [1] 4416 0
02/01/2002
Ethics approval number [1] 4416 0
2002/1/2

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

Contacts
Principal investigator
Name 27984 0
Address 27984 0
Country 27984 0
Phone 27984 0
Fax 27984 0
Email 27984 0
Contact person for public queries
Name 11141 0
Meg Morris
Address 11141 0
School Physiotherapy
The University of Melbourne
200 Berkeley Street
Melbourne VIC 3010
Country 11141 0
Australia
Phone 11141 0
+61 3 83444171
Fax 11141 0
Email 11141 0
m.morris@unimelb.edu.au
Contact person for scientific queries
Name 2069 0
Meg Morris
Address 2069 0
School Physiotherapy
The University of Melbourne
200 Berkeley Street
Melbourne VIC 3010
Country 2069 0
Australia
Phone 2069 0
+61 3 83444171
Fax 2069 0
Email 2069 0
m.morris@unimelb.edu.au

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.