Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000513516
Ethics application status
Approved
Date submitted
11/12/2006
Date registered
11/12/2006
Date last updated
11/12/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
A RANDOMISED CONTROLLED TRIAL TO DETERMINE THE EFFECTS OF A TREADMILL TRAINING PROGRAM FOR SCHOOL AGED CHILDREN WITH CEREBRAL PALSY.
Scientific title
A randomised controlled trial to determine if a treadmill training program for school aged children with cerebral palsy will improve their walking speed and walking endurance
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
School aged children with cerebral palsy 1490 0
Condition category
Condition code
Neurological 1587 1587 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental group intervention: Children in the experimental group will complete a 9-week, twice a week partial body weight support treadmill training program, conducted within normal school hours. A physiotherapist will oversee the program but all of the sessions will be directly supervised by a trained and experienced therapy assistant. The children will wear their usual footwear during training, including any orthoses. At each session, the child will be fitted with the appropriate harness, and then assisted into the partial body weight support apparatus, which will be placed over the treadmill. A large mirror will be positioned in front of the treadmill to provide the child with feedback on postural alignment and to assist motivation. The child will be asked to stand as upright as possible, and the body weight support will be reduced until the child either begins to flex at the hips or knees, or sit in the harness. The treadmill will be started at the lowest speed (0.2kph) and the speed will be gradually increased in 0.1kph increments to a speed where the child is able to step forward comfortably. If required, the trainer will provide assistance to initiate weight shift or to initiate the swing phase of the gait cycle. Similarly if the child can not independently achieve heel strike, the trainer will manually guided the foot to approximate better heel strike. Each session will go for a maximum of 30 minutes. However, the session will finish earlier if the child indicated they want to stop, or if the child stops stepping forward. The trainer will keep a logbook for each child to record the number of sessions attended, the speed of the treadmill during each training session, and the amount of time and distance walked during each session.
Intervention code [1] 1495 0
Treatment: Other
Comparator / control treatment
Control group: Children in the control group will complete a 9-week twice a week walking practice programme overseen by a physiotherapist, but again directly supervised by a trained and experienced therapy assistant. The children will practise walking overground under supervision for a maximum of 30 minutes using their usual walking aid. They will not do any treadmill training.
Control group
Active

Outcomes
Primary outcome [1] 2191 0
The 10 metre self-selected walking speed test
Timepoint [1] 2191 0
Outcome measures will be taken for both the experimental and the control group on three occasions: baseline (week 0), immediately after the 9 week programme (week 10) and 14 weeks after the training programme (week 24).
Secondary outcome [1] 3819 0
1.10 minute walk test
Timepoint [1] 3819 0
All outcome measures will be taken for both the experimental and the control group on three occasions: baseline (week 0), immediately after the 9 week programme (week 10) and 14 weeks after the training programme (week 24).
Secondary outcome [2] 3820 0
2. Cerebral Palsy Quality of Life questionnaire
Timepoint [2] 3820 0
All outcome measures will be taken for both the experimental and the control group on three occasions: baseline (week 0), immediately after the 9 week programme (week 10) and 14 weeks after the training programme (week 24).
Secondary outcome [3] 3821 0
3. School Function Assessment Activity Performance Physical Tasks Subscales
Timepoint [3] 3821 0
All outcome measures will be taken for both the experimental and the control group on three occasions: baseline (week 0), immediately after the 9 week programme (week 10) and 14 weeks after the training programme (week 24).

Eligibility
Key inclusion criteria
(1) have a diagnosis of cerebral palsy, (2) have a functional disability categorized as III or IV on the Gross Motor Function Classification System (GMFCS), and, (3) be able to understand simple instructions, and be able to indicate a desire to cease walking on the treadmill by verbal, gestural, physical or other augmentative means of communication.
Minimum age
5 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) need physical assistance from another person to walk, or 2) if they have a concurrent medical condition such as severe cardiorespiratory disease or uncontrolled epilepsy that would limit their ability to participate in a treadmill training program; 3) had lower limb orthopaedic surgery, botulinum toxin injections or serial casting in the six months before the trial started.Both male and female participnats will be recruited.

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)
For each stratum, the block allocation sequence will be generated by one of the chief investigators from a random-number table and assignments sealed in sequentially numbered opaque envelopes. After enrolment in the study, treatment assignment to either ‘treadmill training’ or ‘control’ will be allocated by opening the next envelope in the sequence and be administered by the research coordinator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation will be achieved using a block randomization method, a method that ensures approximately equal numbers in each group. Consistent with the CONSORT guidelines, a separate randomization procedure will be prepared for each stratum (GMFCS Level III and IV) using permuted blocks. The stratification will ensure that disease severity does not differentially affect the results.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Assessors will be blinded
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/01/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1731 0
University
Name [1] 1731 0
La trobe University
Country [1] 1731 0
Australia
Funding source category [2] 1732 0
Hospital
Name [2] 1732 0
Yooralla Treatment Centre
Country [2] 1732 0
Australia
Primary sponsor type
University
Name
La trobe University
Address
Country
Australia
Secondary sponsor category [1] 1526 0
Charities/Societies/Foundations
Name [1] 1526 0
Yooralla
Address [1] 1526 0
Country [1] 1526 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3199 0
La Trobe University Human ethics Committee
Ethics committee address [1] 3199 0
Ethics committee country [1] 3199 0
Australia
Date submitted for ethics approval [1] 3199 0
Approval date [1] 3199 0
05/12/2006
Ethics approval number [1] 3199 0
06-152

Summary
Brief summary
This study will be the first scientifically rigorous randomised controlled trial comparing the effects of a 9 week treadmill and body weight support training programme compared to walking practice on the walking ability, quality of life and activities of daily living of school aged children with cerebral palsy.

The primary aim of this study is to determine if compared to a supervised walking practice programme, a 9 week, twice a week treadmill and body weight support training programme improves the walking ability (walking speed and walking endurance) of school aged children with cerebral palsy and moderate to severe walking difficulty.

The secondary aims are to (a) to determine if a 9-week, twice a week treadmill and body weight support training programme improves the quality of life and activities of daily living compared to a supervised walking practice programme for school aged children with cerebral palsy and (b) to determine the safety and acceptance of treadmill and body weight support gait training within the child’s normal school environment.

The study hylothesis is:

that a 9 week partial body weight supported treadmill training program will improve the walking performance of school aged children with cerebral palsy more than a 9 week overground walking practice program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27429 0
Address 27429 0
Country 27429 0
Phone 27429 0
Fax 27429 0
Email 27429 0
Contact person for public queries
Name 10684 0
Professor Karen Dodd
Address 10684 0
School of Physiotherapy
La trobe University
Bundoora VIC 3086
Country 10684 0
Australia
Phone 10684 0
+61 3 94795793
Fax 10684 0
Email 10684 0
[email protected]
Contact person for scientific queries
Name 1612 0
Professor Karen Dodd
Address 1612 0
School of Physiotherapy
La trobe University
Bundoora VIC 3086
Country 1612 0
Australia
Phone 1612 0
+61 3 94795793
Fax 1612 0
Email 1612 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

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