Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000220460
Ethics application status
Approved
Date submitted
13/04/2007
Date registered
23/04/2007
Date last updated
28/10/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of daily passive movements on ankle mobility in people with spinal cord injury.
Scientific title
The effects of daily passive movements on ankle mobility in people with spinal cord injury.
Secondary ID [1] 283463 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal cord injury 1749 0
Ankle stiffness 1750 0
Condition category
Condition code
Neurological 1841 1841 0 0
Other injuries and accidents
Musculoskeletal 1842 1842 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The experimental ankle of each subject will receive 20 minutes of passive movements, five days a week for 6 months.
Intervention code [1] 1700 0
Rehabilitation
Comparator / control treatment
The control ankle of each subject will receive no passive movements
Control group
Active

Outcomes
Primary outcome [1] 2580 0
Passive ankle range of motion with the application of 17Nm one day.
Timepoint [1] 2580 0
Measured at the beginning and one-day after the 6 month intervention.
Secondary outcome [1] 4439 0
Passive ankle range of motion with the application of 12Nm.
Timepoint [1] 4439 0
This will be measured at the beginning and one-day after the 6 month intervention.

Eligibility
Key inclusion criteria
1. have sustained a spinal cord injury2. have grade 1/5 strength or less around both knees and ankles3. have at least 15 degrees movement in both ankles4. have signs of ankle stiffness.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects will be excluded if:1. their carers are unable to provide intervention2. they ambulate.

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)
Following initial assessment one ankle of each subject will be randomly assigned to the experimental group. The other ankle of each subject will be assigned to the control group. The allocation schedule will be generated prior to the study by a person not otherwise involved in the study. The allocation schedule of each subject will be concealed in sequentially numbered envelopes. Subjects will be considered to have entered the study once their envelope is opened.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated number sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
within-subject design. That is, one ankle of each subject will be randomly allocated to the treatment group. The other ankle will be allocated to the control group. All assessors will be blinded.
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/04/2007
Actual
10/04/2007
Date of last participant enrolment
Anticipated
Actual
18/12/2007
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1989 0
University
Name [1] 1989 0
University of Sydney
Country [1] 1989 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
The University of Sydney, NSW, 2006
Country
Australia
Secondary sponsor category [1] 1801 0
Government body
Name [1] 1801 0
Motor Accidents Authority of NSW
Address [1] 1801 0
Level 25, 580 George Street
Sydney NSW 2000,
Country [1] 1801 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3695 0
Sydney University
Ethics committee address [1] 3695 0
Ethics committee country [1] 3695 0
Australia
Date submitted for ethics approval [1] 3695 0
Approval date [1] 3695 0
Ethics approval number [1] 3695 0
03-2007/9860
Ethics committee name [2] 3696 0
Royal Rehabilitation Centre Sydney
Ethics committee address [2] 3696 0
Ethics committee country [2] 3696 0
Australia
Date submitted for ethics approval [2] 3696 0
Approval date [2] 3696 0
Ethics approval number [2] 3696 0
07/01

Summary
Brief summary
A randomised within-subjects design will be used to determine the effect of regular passive movements on the ankle. One ankle of each subject will receive 20 minutes of passive movements, five days a week for 6 months. The other ankle will not receive passive movements. The primary outcome measure is passive ankle dorsiflexion with the application of 17Nm torque. All measurements will be taken by blinded assessors.
Trial website
Trial related presentations / publications
Harvey L, Herbert R, Glinsky J, Moseley A, Bowden J (2009) Effects of six months of regular passive movements on ankle joint mobility in people with spinal cord injury: A randomized controlled trial. Spinal Cord. 47: 62-66.

Harvey LA, Herbert RD, Glinsky J, Moseley A and Bowden J (2009) Are regular passive movements effective for the treatment and prevention of contractures? Australian Physiotherapy Association Conference, Sydney, Australia.

Harvey L, Herbert R, Glinsky J, Moseley A, Bowden J (2009) Are passive movements effective for the treatment and prevention of contractures? A randomised controlled trial. The International Spinal Cord Society (ISCOS), Italy.
Public notes

Contacts
Principal investigator
Name 27803 0
A/Prof Lisa Harvey
Address 27803 0
Rehabilitation Studies Unit Royal Rehabilitation Centre Sydney PO Box 6
Ryde, NSW, 1680
Country 27803 0
Australia
Phone 27803 0
61-2-98099099
Fax 27803 0
61-2-98099037
Email 27803 0
[email protected]
Contact person for public queries
Name 10889 0
A/Prof Lisa Harvey
Address 10889 0
Rehabilitation Studies Unit
Royal Rehabilitation Centre Sydney
PO Box 6
Ryde, 1680
Country 10889 0
Australia
Phone 10889 0
61-2-98099099
Fax 10889 0
61-2-98099037
Email 10889 0
[email protected]
Contact person for scientific queries
Name 1817 0
A/Prof Lisa Harvey
Address 1817 0
Rehabilitation Studies Unit
Royal Rehabilitation Centre Sydney
PO Box 6
Ryde NSW 1680
Country 1817 0
Australia
Phone 1817 0
61-2-98099099
Fax 1817 0
61-2-98099037
Email 1817 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
SourceTitleYear of PublicationDOI
EmbasePassive movements for the treatment and prevention of contractures.2013https://dx.doi.org/10.1002/14651858.CD009331.pub2
Dimensions AIEffects of 6 months of regular passive movements on ankle joint mobility in people with spinal cord injury: a randomized controlled trial2008https://doi.org/10.1038/sc.2008.71
N.B. These documents automatically identified may not have been verified by the study sponsor.