Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000553471
Ethics application status
Approved
Date submitted
25/10/2007
Date registered
26/10/2007
Date last updated
3/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Targeted strength training to improve functional walking capacity of adolescents and young adults with cerebral palsy
Scientific title
A randomised controlled trial to find out if targeted strength training can improve the functional walking capacity of adolescents and young adults with diplegic cerebral palsy
Secondary ID [1] 288063 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cerebral palsy 2507 0
Condition category
Condition code
Neurological 2603 2603 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Progressive resistance strength training (PRST) in a community gymnasium, twice a week for 12 weeks targeting the major muscles in the lower limbs contributing to limited walking ability. Participants will complete 2 to 3 sets of 10 to 12 repetitions of each exercise, with a 2 minute break between each set, at an intensity of 10-12 repetition maximum and exercise under the supervision of a physiotherapist.
Intervention code [1] 2234 0
Rehabilitation
Comparator / control treatment
Participants allocated to the control group will continue usual care during the 12-weeks between baseline and testing including their usual recreation and physiotherapy provided that these do not include progressive resistance trength training (PRST).
Control group
Active

Outcomes
Primary outcome [1] 3514 0
6 minute walk test
Timepoint [1] 3514 0
All outcome measurements will be taken three times: at baseline, after 12 weeks, and after a further 12 weeks (24 weeks)
Secondary outcome [1] 5862 0
Activity levels:
will be measured with an accelerometer-based activity monitor, monitoring step counts and time spent in sitting/lying, standing, and walking over a 3-day period
Timepoint [1] 5862 0
All outcome measurements will be taken three times: at baseline, after 12 weeks, and after a further 12 weeks (24 weeks)
Secondary outcome [2] 5863 0
Gait kinematics:
The Gillette Gait Index, formerly known as the Normalcy Index, will be used to document the effect of PRST on gait kinematics. Derived from principal component analysis of 16 kinematic variables the Gillette Gait Index produces a dimensionless unit that indicates how much walking deviates from normal
Timepoint [2] 5863 0
All outcome measurements will be taken three times: at baseline, after 12 weeks, and after a further 12 weeks (24 weeks)
Secondary outcome [3] 5864 0
Muscle strength:
Dynamic strength will be assessed using one repetition maximum of a leg press (using the major antigravity support muscles of hip extensors, knee extensors and plantar flexors) and a reverse leg press (using the major lift-off muscles of hip flexors, knee flexors and ankle dorsiflexors).
A hand held dynamometer will be used to assess isometric strength of the specific muscles targeted for each participant.
Timepoint [3] 5864 0
All outcome measurements will be taken three times: at baseline, after 12 weeks, and after a further 12 weeks (24 weeks)

Eligibility
Key inclusion criteria
(i) Diplegic cerebral palsy aged between 14 and 22 years
(ii) Gross Motor Function Classification System (GMFCS) level II or III.
(iii) Approval from a medical practitioner to participate in PRST.
(iv) Ability to follow simple instructions so that the participant can complete the prescribed exercise program.
Minimum age
14 Years
Maximum age
22 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) Single event multi-level orthopaedic surgery within the previous 2 years
(ii) Participation in a PRST program in the 6 months prior to the start of the trial
(iii) Contractures of more than 10º at the hip and knee

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)
Sealed sequentially numbered opaque envelopes administered by a researcher independent of the project
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block allocation sequence will be generated using a random numbers table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2008
Actual
9/10/2008
Date of last participant enrolment
Anticipated
Actual
18/08/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
66
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 307 0
3052

Funding & Sponsors
Funding source category [1] 2752 0
Government body
Name [1] 2752 0
National Health & Medical Research Council (NHMRC) project grant
Country [1] 2752 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University
Victoria 3086
Australia
Country
Australia
Secondary sponsor category [1] 2486 0
Hospital
Name [1] 2486 0
Royal Children's Hospital, Melbourne
Address [1] 2486 0
Royal Children's Hospital
Flemington Rd
Parkville Victoria 3052
Australia
Country [1] 2486 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4674 0
Royal Childrens Hospital Human Research Ethics Committee
Ethics committee address [1] 4674 0
Ethics committee country [1] 4674 0
Australia
Date submitted for ethics approval [1] 4674 0
15/11/2007
Approval date [1] 4674 0
29/04/2008
Ethics approval number [1] 4674 0
Royal Childrens Hospital 28006

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

Contacts
Principal investigator
Name 28147 0
Prof Nicholas Taylor
Address 28147 0
School of Allied Health, La Trobe University, Victoria 3086.
Country 28147 0
Australia
Phone 28147 0
61 3 94795860
Fax 28147 0
Email 28147 0
[email protected]
Contact person for public queries
Name 11304 0
Professor Nicholas Taylor
Address 11304 0
School of Allied Health, La Trobe University Victoria 3086
Country 11304 0
Australia
Phone 11304 0
61 3 9479 5860
Fax 11304 0
Email 11304 0
[email protected]
Contact person for scientific queries
Name 2232 0
Professor Nicholas Taylor
Address 2232 0
School of Allied Health, La Trobe University Victoria 3086
Country 2232 0
Australia
Phone 2232 0
61 3 9479 5860
Fax 2232 0
Email 2232 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.