Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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.
Query!
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.
Query!
Secondary ID [1]
283102
0
Nil known
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy
289942
0
Query!
Condition category
Condition code
Neurological
290316
290316
0
0
Query!
Other neurological disorders
Query!
Physical Medicine / Rehabilitation
290454
290454
0
0
Query!
Physiotherapy
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
287819
0
Rehabilitation
Query!
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.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
290355
0
Changes in endurance as measured via a Six Minute Endurance Walk (6 MWT)
Query!
Assessment method [1]
290355
0
Query!
Timepoint [1]
290355
0
Baseline (week 0), immediately after training (week 4) and after completion of training (week 8).
Query!
Primary outcome [2]
290481
0
Walking speed as measured by the 10 metre wlak test (10mwt)
Query!
Assessment method [2]
290481
0
Query!
Timepoint [2]
290481
0
Baseline (week 0) week 4 and week 8
Query!
Secondary outcome [1]
304351
0
Changes in function as measured by the Gross Motor function (88)
Query!
Assessment method [1]
304351
0
Query!
Timepoint [1]
304351
0
Baseline (week 0), immediately after training (week 4) and after completion of training (week 8).
Query!
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.
Query!
Minimum age
6
Years
Query!
Query!
Maximum age
18
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
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).
Query!
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.
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Query!
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.
Query!
Recruitment
Recruitment status
Recruiting
Query!
Date of first participant enrolment
Anticipated
4/09/2013
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
30
Query!
Accrual to date
Query!
Final
Query!
Recruitment outside Australia
Country [1]
5346
0
Singapore
Query!
State/province [1]
5346
0
Query!
Funding & Sponsors
Funding source category [1]
287857
0
Self funded/Unfunded
Query!
Name [1]
287857
0
None
Query!
Address [1]
287857
0
None
Query!
Country [1]
287857
0
Query!
Primary sponsor type
University
Query!
Name
Flinders University of SA
Query!
Address
C Block, Repatriation General Hospital, Daws Road, Daw Park SA 5041
Query!
Country
Australia
Query!
Secondary sponsor category [1]
286586
0
Other
Query!
Name [1]
286586
0
Cerebral Palsy Alliance Singapore
Query!
Address [1]
286586
0
Cerebral Palsy Centre, 65 Pasir Ris Drive 1, Singapore 519529
Query!
Country [1]
286586
0
Singapore
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
289800
0
Southern Adelaide Clinical Human Research Ethics Committee
Query!
Ethics committee address [1]
289800
0
The Flats G5 - Rooms 3 and 4
flinders Drive
Flinders Medical Centre
Bedford Park SA 5042
Query!
Ethics committee country [1]
289800
0
Australia
Query!
Date submitted for ethics approval [1]
289800
0
26/08/2013
Query!
Approval date [1]
289800
0
Query!
Ethics approval number [1]
289800
0
317.13
Query!
Summary
Brief summary
To investigate the change in endurance, walking speed and function after Partial Body Weight Supported Treadmill Training (PBWSTT) in children with Cerebral Palsy with Gross Motor Function Classification System (GMFCS) Level II and III. To compare the result obtained with the overground walking in children with CP. It is hypothesised that children in the treatment group (PBWSTT) will have greater endurance, walking speed and function.
In Singapore there has been a dearth of study to investigate the effectiveness of Partial Body Weight Supported Treadmill Training (PBWSTT) in children with Cerebral Palsy, hence this study will allow the clinician to select appropriate intervention for children with Cerebral Palsy and as well as to investigate the evidence supporting Treadmill Training (TT) with PBWSTT.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
42502
0
Dr Chris Barr
Query!
Address
42502
0
Rehabilitation, Aged & Extended Care
C Block
Repatriation General Hospital
Daws Road Daw Park SA 5041
Query!
Country
42502
0
Australia
Query!
Phone
42502
0
+61 8 8275 1103
Query!
Fax
42502
0
+61 8 8275 1130
Query!
Email
42502
0
[email protected]
Query!
Contact person for public queries
Name
42503
0
Dr Chris Barr
Query!
Address
42503
0
Rehabilitation, Aged & Extended Care
C Block
Repatriation General Hospital
Daws Road Daw Park SA 5041
Query!
Country
42503
0
Australia
Query!
Phone
42503
0
+61 8 8275 1103
Query!
Fax
42503
0
+61 8 8275 1130
Query!
Email
42503
0
[email protected]
Query!
Contact person for scientific queries
Name
42504
0
Dr Chris Barr
Query!
Address
42504
0
Rehabilitation, Aged & Extended Care
C Block
Repatriation General Hospital
Daws Road Daw Park SA 5041
Query!
Country
42504
0
Australia
Query!
Phone
42504
0
+61 8 8275 1103
Query!
Fax
42504
0
+61 8 8275 1130
Query!
Email
42504
0
[email protected]
Query!
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.
Download to PDF