Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000713291
Ethics application status
Approved
Date submitted
17/08/2009
Date registered
18/08/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Electrical stimulation in botulinum toxin A use in children with cerebral palsy: a randomised trial
Scientific title
Cerebral palsy and electrical stimulation - does stimulation of the gastrocnemius muscle pre- and post-botulinum toxin A injection for dynamic equinus facilitate greater uptake of the toxin when measured by clinical examination and 3-D gait analysis?
Secondary ID [1] 279705 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral palsy, both hemiplegic and diplegic conditions, in children aged 4-12 years old. 243528 0
Condition category
Condition code
Physical Medicine / Rehabilitation 239827 239827 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention being studied is electrical stimulation, as provided by a commercially available functional electrical stimulation (FES) device. The intervention group receives stimulation pre-botox (in theatre, applied directly to the gastrocnemius muscle via an insulated surgical needle, for 2 minutes) and then post-injection over the next 2 days (one 30 min session that evening, three 30 min sessions the following day, and three 30 min sessions on day two - seven 30 min stimulation sessions in total). Standard botox dosing is used (in the range of 3-6 units per kilogram) and every subject receives routine physiotherapy post-botox.
Intervention code [1] 241137 0
Treatment: Devices
Comparator / control treatment
All participants are receiving botox A for dynamic equinus. The control group does not receive stimulation in any form. Every subject receives routine physiotherapy post-botox.
Control group
Active

Outcomes
Primary outcome [1] 240591 0
The primary outcome is the peak dorsiflexion angle in stance phase in the sagittal plane recorded in gait analysis.
Timepoint [1] 240591 0
3-D gait analysis (kinematics and kinetics) measured at 6 and 12 weeks post-botox injection, with comparison to baseline (pre-injection measure) and physiotherapy assessment.
Secondary outcome [1] 257221 0
Secondary outcomes are: (1) angles of dorsiflexion/plantarflexion at the ankle and knee at initial contact, mid stance, and terminal stance; and
Timepoint [1] 257221 0
3-D gait analysis (kinematics and kinetics) measured at 6 and 12 weeks post-botox injection, with comparison to baseline (pre-injection measure) and physiotherapy assessment.
Secondary outcome [2] 257233 0
(2) the modified Ashworth and modified Tardieu scores, both clinical measures of spasticity, as well as the selective motor control score.
Timepoint [2] 257233 0
3-D gait analysis (kinematics and kinetics) measured at 6 and 12 weeks post-botox injection, with comparison to baseline (pre-injection measure) and physiotherapy assessment.

Eligibility
Key inclusion criteria
1. Children between the ages of 4 and 12 years with a confirmed diagnosis of spastic hemiplegic or spastic diplegic cerebral palsy (CP)
2. Planned injection of gastrocnemius muscle for the treatment of dynamic equinus deformity
3. Walking ability described by classification at Gross Motor Functional Classification System (GMFCS) levels one to three (walks independently or with assistive devices)
4. Ongoing participation in a community-based therapy programme.
Minimum age
4 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Previous lower limb surgery involving the calf and/or hamstring
2. Use of botox A in the calf muscle within the last six months
3. Inability to follow a single stage command
4. Inability to walk along a 10m walk way for a total of five trials
5. Presence of fixed muscle contractures.
6. Casting post-botox injection

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)
Minimisation randomisation is used to allocate subjects to one of 4 groups, based on age and condition. Ie:
Group A - 4-8 yrs, hemi CP,
Group B - 4-8 yrs, diplegic CP,
Group C - 9-12 yrs, hemi CP,
Group D - 9-12 yrs, diplegic CP.
The blinded Allocatur has an envelope with 4 cards in it for each group - 2 purple (control) and 2 blue (intervention). When a subject is recruited, they are allocated to the appropriate group based on their age and condition and a card is randomly drawn from the appropriate envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All children receiving botox A for dynamic equinus through the Women's and Children's Hospital in Adelaide, South Australia (SA), are screened for possible inclusion by the Study Coordinator (as per inclusion/exclusion criteria). Eligible potential subjects are identified and suitability is confirmed by consultation with the child's Rehabilitation Physician or Physiotherapist. The Study Coordinator then contacts the relevant family about the study and further written information is posted/emailed if requested. If families are happy to proceed, they consent to their child being enrolled in the study. The subject undergoes baseline measurement for the study (prior to their botox injection date) and a blinded Allocatur uses minimisation randomisation to allocate the subject to a group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
9/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2032 0
5000-5799

Funding & Sponsors
Funding source category [1] 237510 0
Charities/Societies/Foundations
Name [1] 237510 0
Channel 7 Children's Research Foundation
Country [1] 237510 0
Australia
Primary sponsor type
Hospital
Name
Women's and Children's Hospital
Address
72 King William Road,
North Adelaide, SA, 5006
Country
Australia
Secondary sponsor category [1] 236989 0
Charities/Societies/Foundations
Name [1] 236989 0
Novita Children's Services
Address [1] 236989 0
171 Days Road,
Regency Park, SA, 5010
Country [1] 236989 0
Australia
Other collaborator category [1] 821 0
Hospital
Name [1] 821 0
South Australian Movement Analysis Laboratory
Address [1] 821 0
C/o - Repatriation General Hospital
Daws Road,
Daw Park, SA, 5041
Country [1] 821 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243639 0
Children, Youth & Women's Health Service Research Ethics Committee
Ethics committee address [1] 243639 0
C/o - Women's and Children's Hospital
72 King William Road,
North Adelaide, SA, 5006
Ethics committee country [1] 243639 0
Australia
Date submitted for ethics approval [1] 243639 0
Approval date [1] 243639 0
20/03/2009
Ethics approval number [1] 243639 0
REC2143/2/12
Ethics committee name [2] 243640 0
Repatriation General Hospital Research and Ethics Committee
Ethics committee address [2] 243640 0
C/o - Repatriation General Hospital
Daws Road,
Daw Park, SA, 5041
Ethics committee country [2] 243640 0
Australia
Date submitted for ethics approval [2] 243640 0
Approval date [2] 243640 0
30/03/2009
Ethics approval number [2] 243640 0
18/09/2009

Summary
Brief summary
Children with cerebral palsy (CP) have difficulty with mobility due to increased muscle tone (spasticity) and weakness in their legs. In recent years, botulinum toxin type A (BoNT-A, or botox) has been used to treat muscle spasticity, providing an opportunity for physiotherapy to improve walking ability and endurance. Current research findings suggest that the effect of botox can be increased by making sure that injected muscles are actively contracting at the time of injection. If this theory is correct, strategies which “activate” the injected muscle may play a vital role in making the most of a given botox treatment.

This project will test this theory by comparing 2 groups of children who receive botox; one group will also receive electrical stimulation to the affected calf muscle at the time of the botox injection, and the other group will only receive the injection. Both groups will then receive standard post-injection physiotherapy. The two groups will then have their walking ability assessed using specialised gait analysis. This project has the potential to improve the effects of botox treatment for all children who are injected.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30058 0
Address 30058 0
Country 30058 0
Phone 30058 0
Fax 30058 0
Email 30058 0
Contact person for public queries
Name 13305 0
David Hobbs
Address 13305 0
Flinders University, Sturt Road, Bedford Park, SA, 5042
Country 13305 0
Australia
Phone 13305 0
+618 8201 3167
Fax 13305 0
+618 8201 2904
Email 13305 0
david.hobbs@flinders.edu.au
Contact person for scientific queries
Name 4233 0
Dr James Rice
Address 4233 0
C/o - Women's and Children's Hospital
72 King William Road,
North Adelaide, SA, 5006
Country 4233 0
Australia
Phone 4233 0
+618-8161-7367
Fax 4233 0
+618-8161-8488
Email 4233 0
james.rice@health.sa.gov.au

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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