Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000531910
Ethics application status
Approved
Date submitted
20/05/2011
Date registered
23/05/2011
Date last updated
1/09/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of 8 weeks daily community use of the Walk Aide on children with unilateral cerebral palsy
Scientific title
Effects of 8 weeks daily community use of the Walk Aide on children with unilateral cerebral palsy
Secondary ID [1] 262215 0
Nil
Universal Trial Number (UTN)
UN1111-1121-5948
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy - Spastic Hemiplegia 267902 0
Condition category
Condition code
Physical Medicine / Rehabilitation 268052 268052 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The application of functional electrical stimulation on children aged 5 to 18 years with cerebral palsy - spastic hemiplegia (Winters Gage and Hicks classification Type 1 and 2). Children will be required to wear a small portable device on their leg which will stimulate the ankle dorsiflexors during the swing phase of gait for a period of 6 weeks. Children will be expected to wear the device for at least 1 hour per day, 6 days a week throughout this 6 week intervention phase.

There are 3 phases to this study as this is an ABA single subject design. The first phase is the preintervention phase which is 6 weeks in duration. During this phase, participants will be asked to continue with their usual regime. The next phase is the B- intervention phase which as described earlier is also 6 weeks. The final phase is the A - post intervention phase which will last up to 12 weeks. This phase will determine if there are any carry over effects from the intervention and if there are, how long they will last for. Assessments will occur weekly throughout the 3 phases with 2D gait video taken every 3 weeks.
Intervention code [1] 264610 0
Rehabilitation
Intervention code [2] 264611 0
Treatment: Devices
Comparator / control treatment
No control treatment as this is a single subject design
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266794 0
Selective Motor Control - Measurement of selective and isolated dorsiflexion on a 5 point scale (Boyd and Graham 1999)
Timepoint [1] 266794 0
Weekly throughout the 3 phases of the study
Primary outcome [2] 266795 0
Isometric Muscle Strength using a Hand Held Dynamometer for dorsiflexion and plantarflexion of the ankle joint
Timepoint [2] 266795 0
Weekly throughout the 3 phases of study
Primary outcome [3] 266796 0
2D gait video analysis will be used to determine peak dorsiflexion during swing as well as degree of dorsiflexion at initial contact with and without the electrical stimulation. Physician Rating Scale for Gait Analysis (using Boyd et al 1999) will be used.
Timepoint [3] 266796 0
2D gait video will occur before the commencement of the first phase of the study (6 weeks pre intervention phase to establish baseline) and every 3 weeks there after until the subject is 12 weeks post intervention.
Secondary outcome [1] 276399 0
Range of Motion will be measured using manual goniometry for the popliteal angles (bilaterally) as well as dorsiflexion with knee flexion and extension and ankle eversion in plantigrade position.
Timepoint [1] 276399 0
Weekly thorughout the 3 phases of the study
Secondary outcome [2] 276400 0
Spasticity using the Modified Tardieu and Australian Spasticity Assessment Scale for hamstrings, gastrocnemius, soleus and tibialis posterior
Timepoint [2] 276400 0
Weekly throughout the 3 phases of the study
Secondary outcome [3] 276401 0
Single Limb Balance will be measured by the length of time (using a stop watch) the subject can balance on one leg for
Timepoint [3] 276401 0
Weekly throughout the 3 phases of the study
Secondary outcome [4] 276402 0
Calf Circumference - circumferential measurements will be taken of the leg
Timepoint [4] 276402 0
Weekly throughout the 3 phases of the study
Secondary outcome [5] 276405 0
Subjective Reports from the Subjects using a questionnaire which focuses on how the subjects perceive the intervention and the effects it has on their mobility
Timepoint [5] 276405 0
Pre 6 week intervention, Post intervention and then again at 6 weeks and 12 weeks post intervention.

Eligibility
Key inclusion criteria
Spastic Hemiplegia
Children aged between 5 and 18 years
Achieves full bilateral knee extension
Has at least 5 degrees of ankle dorsiflexion on the affected side
Dynamic popliteal angle no more than 45 degrees
Able to follow instructions
Willing to use the Walk Aide device for at least 1 hour a day, 6 days a week for 6 weeks.
Minimum age
5 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Orthopaedic lengthening to gastrocs/tendo achilles in the last 12 months
History of Seizure Disorder

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
If the subject meets the inclusion criteria and is able to tolerate the electrical stimulation, they will be included in this study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No randomisation applies to this study
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2011
Actual
23/01/2012
Date of last participant enrolment
Anticipated
30/03/2012
Actual
23/02/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267111 0
Charities/Societies/Foundations
Name [1] 267111 0
The Cerebral Palsy Foundation
Country [1] 267111 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Centre for Cerebral Palsy
Address
PO Box 61 Mount Lawley WA 6929
Country
Australia
Secondary sponsor category [1] 264190 0
None
Name [1] 264190 0
Address [1] 264190 0
Country [1] 264190 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267091 0
PMH Ethics Committee
Ethics committee address [1] 267091 0
Ethics committee country [1] 267091 0
Australia
Date submitted for ethics approval [1] 267091 0
06/06/2011
Approval date [1] 267091 0
13/01/2012
Ethics approval number [1] 267091 0

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

Contacts
Principal investigator
Name 32634 0
Mrs Dayna Pool
Address 32634 0
The Centre for Cerebral Palsy
PO Box 61 Mount Lawley Western Australia 6929
Country 32634 0
Australia
Phone 32634 0
+61 89443 0388
Fax 32634 0
Email 32634 0
[email protected]
Contact person for public queries
Name 15881 0
Dayna Pool
Address 15881 0
PO Box 61 Mount Lawley Western Australia 6929
Country 15881 0
Australia
Phone 15881 0
+61 8 9443 0388
Fax 15881 0
Email 15881 0
[email protected]
Contact person for scientific queries
Name 6809 0
Dayna Pool
Address 6809 0
PO Box 61 Mount Lawley Western Australia 6929
Country 6809 0
Australia
Phone 6809 0
+61 89443 0388
Fax 6809 0
Email 6809 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.