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Trial registered on ANZCTR


Registration number
ACTRN12613001025729
Ethics application status
Approved
Date submitted
11/09/2013
Date registered
13/09/2013
Date last updated
13/09/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of Partial Body Weight-Supported Treadmill Training (PBWSTT) Compared with Overground Walking Practice on Endurance and Walking Speed in Children with Cerebral Palsy (CP): A Randomised Controlled Trial.
Scientific title
Efficacy of Partial Body Weight-Supported Treadmill Training (PBWSTT) Compared with Overground Walking Practice on Endurance and Walking Speed in Children with Cerebral Palsy (CP): A Randomised Controlled Trial.
Secondary ID [1] 283102 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy 289942 0
Condition category
Condition code
Neurological 290316 290316 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 290454 290454 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Partial Body Weight-Supported Treadmill Training (PBWSTT) in children. This is a method used in neurological rehabilitation of adults and children that provides task-specific gait training with multiple repetitions and active participation of the client, which has been demonstrated to enhance motor learning.
Partial body weight is facilitated via the use of a harness. sessions will be administered 2xper week over an 8 week period, each session lasting up to 30 minutes. Sessions will be administered by the physiotherapists at the school where the study will take place. Participants will be encouraged to increase their duration and / or walking speed, and / or decrease the amount of body weight support over the duration of the 8 week study as deemed appropriate by the treating physiotherapist.

The number of sessions and duration of each session will be recorded. In the event that a participant misses a session they will be provided with a catch up session in the next week.
Intervention code [1] 287819 0
Rehabilitation
Comparator / control treatment
The control group will be provided with the same number of physiotherapy sessions, again lasting up to 30 minutes, over the 8 week period. the control group will be trained by overground walking, and will be encouraged to increase their speed / duration as deemed appropriate by the treating physiotherapist.
Control group
Active

Outcomes
Primary outcome [1] 290355 0
Changes in endurance as measured via a Six Minute Endurance Walk (6 MWT)
Timepoint [1] 290355 0
Baseline (week 0), immediately after training (week 4) and after completion of training (week 8).
Primary outcome [2] 290481 0
Walking speed as measured by the 10 metre wlak test (10mwt)
Timepoint [2] 290481 0
Baseline (week 0) week 4 and week 8
Secondary outcome [1] 304351 0
Changes in function as measured by the Gross Motor function (88)
Timepoint [1] 304351 0
Baseline (week 0), immediately after training (week 4) and after completion of training (week 8).

Eligibility
Key inclusion criteria
Students will be included with:
(i) a diagnosis of CP and aged between 6 and 18 years.
(ii) Gross Motor Function Classification System (GMFCS) Levels II (walks without assistive mobility devices but has limitations walking outdoor and in the community) and III (walks with assistive mobility devices but has limitations walking outdoors and in the community).
(iii) an ability to follow verbal directions for standardized testing.
Minimum age
6 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Students will be excluded if they had:
(i) visual impairment that could compromise the performance of the tasks.
(ii) a concurrent medical condition such as severe cardio respiratory disease or uncontrolled epilepsy that will pose a risk to their safety during training.
(iii) lower limb orthopaedic surgery or botulinum toxin injections in the 6 months.

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)
Students will be randomly allocated to the intervention or control group by a block randomisation method according to Gross Motor Function Classification System (GMFCS) levels, gender and age (6-12y or 13-18y).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
For each stratum, the allocation sequence will be generated from a random numbers table with assignments sealed in sequentially number opaque envelopes. After the enrolment, the participants will be assigned to a group by opening the next envelope. This process will be administered by a team member not known to any of the parcitipants and not involved in recruitment or the training programs.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The obtained data will be subjected to statistical analysis using SPSS software to determine the:
1. baseline differences between the groups using independent t tests.
2. effects of training at week 4 and week 8 by ANCOVA.
3. significance between groups using independent sample t tests.
As per the profiling of the students, done for the purpose of database by the school, there is higher number of boys in GMFCS Level II and III with better cognitive abilities as compared to girls. Henceforth, the study will include 20 boys and 10 girls.


The clinically accepted improvement in gait speed is 0.1m/s. Using data from Dodd and Foley (2007), who had 2 groups with 7 participants each, the average SD for walking speed at baseline was 0.09m/s. A power calculation using 0.09 as the SD and a mean change of 0.1, with an alpha of 0.05 and power of 0.8, 14 participants per group are required. We propose a recruitment target of 30 to cover the possibility of a drop out in each group.

Additionally, a similar study by Willoughby et al (2010) conducted a power calculation using their own pilot data and suggested that 15 participants in each group (30 total) would be sufficient to detect a significant difference for an 80% power at the 0.05 level. While their results did not reach statistical difference, they recruited a more functionally disabled group (GMFCS III and IV). The number, duration and frequency of intervention is also clinically feasible in the setting the study will take place in.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/09/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 5346 0
Singapore
State/province [1] 5346 0

Funding & Sponsors
Funding source category [1] 287857 0
Self funded/Unfunded
Name [1] 287857 0
None
Country [1] 287857 0
Primary sponsor type
University
Name
Flinders University of SA
Address
C Block, Repatriation General Hospital, Daws Road, Daw Park SA 5041
Country
Australia
Secondary sponsor category [1] 286586 0
Other
Name [1] 286586 0
Cerebral Palsy Alliance Singapore
Address [1] 286586 0
Cerebral Palsy Centre, 65 Pasir Ris Drive 1, Singapore 519529
Country [1] 286586 0
Singapore

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289800 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 289800 0
Ethics committee country [1] 289800 0
Australia
Date submitted for ethics approval [1] 289800 0
26/08/2013
Approval date [1] 289800 0
Ethics approval number [1] 289800 0
317.13

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

Contacts
Principal investigator
Name 42502 0
Dr Chris Barr
Address 42502 0
Rehabilitation, Aged & Extended Care
C Block
Repatriation General Hospital
Daws Road Daw Park SA 5041
Country 42502 0
Australia
Phone 42502 0
+61 8 8275 1103
Fax 42502 0
+61 8 8275 1130
Email 42502 0
[email protected]
Contact person for public queries
Name 42503 0
Chris Barr
Address 42503 0
Rehabilitation, Aged & Extended Care
C Block
Repatriation General Hospital
Daws Road Daw Park SA 5041
Country 42503 0
Australia
Phone 42503 0
+61 8 8275 1103
Fax 42503 0
+61 8 8275 1130
Email 42503 0
[email protected]
Contact person for scientific queries
Name 42504 0
Chris Barr
Address 42504 0
Rehabilitation, Aged & Extended Care
C Block
Repatriation General Hospital
Daws Road Daw Park SA 5041
Country 42504 0
Australia
Phone 42504 0
+61 8 8275 1103
Fax 42504 0
+61 8 8275 1130
Email 42504 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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