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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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
Universal Trial Number (UTN)
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

Study type
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
Intervention code [2] 264611 0
Treatment: Devices
Comparator / control treatment
No control treatment as this is a single subject design
Control group

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.

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
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Orthopaedic lengthening to gastrocs/tendo achilles in the last 12 months
History of Seizure Disorder

Study design
Purpose of the study
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
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267111 0
Name [1] 267111 0
The Cerebral Palsy Foundation
Address [1] 267111 0
PO Box 61 Mount Lawley WA 6929
Country [1] 267111 0
Primary sponsor type
The Centre for Cerebral Palsy
PO Box 61 Mount Lawley WA 6929
Secondary sponsor category [1] 264190 0
Name [1] 264190 0
Address [1] 264190 0
Country [1] 264190 0

Ethics approval
Ethics application status
Ethics committee name [1] 267091 0
PMH Ethics Committee
Ethics committee address [1] 267091 0
GPO Box D 184 Perth WA 6840
Ethics committee country [1] 267091 0
Date submitted for ethics approval [1] 267091 0
Approval date [1] 267091 0
Ethics approval number [1] 267091 0

Brief summary
Cerebral Palsy is a term that describes a group of primarily motor disorders. Spastic Hemiplegia is a common presentation of cerebral palsy where one side of the body is weaker and muscles are often tighter and more difficult to move. As such, walking can be affected as the foot "catches" on the floor when taking a step and can cause tripping or even falling over.
The Walk Aide is a small device that is strapped to the leg just below the knee. It provides electrical impulses to stimulate the muscles that lift up the foot during walking thus preventing tripping and catching of the foot on the ground. The device is portable and can be worn where ever the child wishes to go.
Our study aims to see what effects the Walk Aide might have on strength, ease of movement and balance whilst using the Walk Aide but also after using the Walk Aide to determine if the effects last even beyond the use of wearing the device.
Trial website
Trial related presentations / publications
Published in:
Paediatric Physical Therapy Fall Edition 26(3) Pg 308-17

Title: Effects of short term daily community walk aide use in children with unilateral spastic cerebral palsy.

Authors: Pool, D; Blackmore, AM; Bear, N; Valentine, J
Public notes

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
Phone 32634 0
+61 89443 0388
Fax 32634 0
Email 32634 0
Contact person for public queries
Name 15881 0
Mrs Dayna Pool
Address 15881 0
PO Box 61 Mount Lawley Western Australia 6929
Country 15881 0
Phone 15881 0
+61 8 9443 0388
Fax 15881 0
Email 15881 0
Contact person for scientific queries
Name 6809 0
Mrs Dayna Pool
Address 6809 0
PO Box 61 Mount Lawley Western Australia 6929
Country 6809 0
Phone 6809 0
+61 89443 0388
Fax 6809 0
Email 6809 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary