Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000949684
Ethics application status
Approved
Date submitted
23/08/2014
Date registered
4/09/2014
Date last updated
27/10/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Functional electrical stimulation in children with unilateral spastic cerebral palsy: A study of the effects based on the international classification of functioning framework.
Scientific title
Functional electrical stimulation in children with unilateral spastic cerebral palsy: A study of the effects based on the international classification of functioning framework.
Secondary ID [1] 285211 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
The W.A.L.K. Study (Walk Aide in Limbs of Kids)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unilateral Spastic Cerebral Palsy 292832 0
Condition category
Condition code
Neurological 293132 293132 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 293225 293225 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Community based functional electrical stimulation to the ankle dorsiflexors during the swing phase of gait. The electrical stimulation is applied through a device known as a Walk Aide which is strapped to the leg just below the knee. The tilt sensor is programmed so that stimulation is turned on at the commencement of swing phase through to initial contact. The intensity of stimulation will vary according to each individual but all participants will have a frequency of 33Hz and a pulse width ranging from 25 to 300 micro seconds. The amplitude will be participant controlled by a dial. Participants are asked to use the Walk Aide for a minimum of 4 hours a day, 6 days a week over the 8 week intervention period. Weekly to fortnightly school and home visits will be conducted for each participant to monitor the intervention. The Walk Aide has an inbuilt usage log therefore at each visit, this data will be downloaded so that the participant and the family can receive feedback regarding adherence to the dosage. Families will also have direct access to the principle investigator via mobile text message and email if there are any queries or concerns.
Intervention code [1] 290088 0
Rehabilitation
Intervention code [2] 290160 0
Treatment: Devices
Comparator / control treatment
Control group of no functional electrical stimulation. Participants in the control are asked to maintain their current levels of therapeutic input and use of ankle foot orthoses.
Control group
Active

Outcomes
Primary outcome [1] 292994 0
Muscle volume of lower limb muscles measured by MRI and computed through Mimics Software for total volume
Timepoint [1] 292994 0
Baseline, post 8 weeks of FES treatment and 6 weeks follow up
Primary outcome [2] 292995 0
Strength of ankle dorsiflexors and ankle plantarflexors measured by hand held dynamometry and total number of unilateral heel raises
Timepoint [2] 292995 0
Baseline, 8 weeks post FES treatment, 6 weeks follow up
Primary outcome [3] 292996 0
Lower limb Selective motor control using the SCALE and Boyd and Graham's ankle dorsiflexion measure
Timepoint [3] 292996 0
Baseline, 8 weeks post FES treatment and 6 weeks follow up
Secondary outcome [1] 310099 0
Ankle range of motion and spasticity of gastrocnemius measured by goniometer and Australian Spastic Assessment Scale and Modified Tardieu
Timepoint [1] 310099 0
Baseline, 8 weeks post FES treatment and 6 weeks follow up
Secondary outcome [2] 310100 0
Sensation of the foot measurement by the Semmes and Weinsten Monofilaments
Timepoint [2] 310100 0
Baseline, 8 weeks post FES and 6 weeks follow up
Secondary outcome [3] 310101 0
Activity and participation measures including the Community Mobility Balance Scale and the Canadian Occupational Performance Measure
Timepoint [3] 310101 0
Baseline, 8 weeks post FES and 6 weeks follow up
Secondary outcome [4] 310102 0
Ankle kinematics and temporal spatial measures using 2D gait analysis walking with and without the walk aide.
Timepoint [4] 310102 0
Baseline, 8 weeks post FES treatment and 6 weeks follow up

Eligibility
Key inclusion criteria
Children with unilateral spastic hemiplegia, GMFCS I or II with at least 5 degrees of ankle dorsiflexion, 3 months post botulinum toxin, no knee flexion contracture and able to follow instructions required for assessment procedures.
Minimum age
5 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Uncontrolled seizure disorder, orthopaedic metalware around the knee and leg (site of electrical stimulation)

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)
This is a matched pairs randomised controlled trial. Potential participants meeting the inclusion criteria are referred to the study from physiotherapists and paediatric rehabilitation consultants. An initial appointment is then scheduled to determine FES tolerance and study protocol. Once informed consent is obtained from two participants that meet the criteria for a match, they are then randomly allocated - one to the FES group and one to the control group. Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a coin toss
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Participants are matched by age (within 2 years for children between 5 and 10 and within 6 years for children between 11 and 18) and GMFCS level (1 or 2)
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
The distributions of strength, ROM, muscle volume, ankle power and the COPM will be assessed for normality through the Shaprio Wilks test and the Q plot. SMC, SCALE, sensation, spasticity (ASAS) and CBMS are ordinal scales that cannot be assumed to be equal interval, therefore non-parametric tests will be used for these outcomes. Due to the heterogeneous nature of the subjects, difference between the groups at baseline will be assessed. Difference scores will be assessed using either an independent t test or the Mann Whitney U test (depending on the distribution of the variable). Between group analysis will be performed using an independent t test. When normality assumptions are not met the non-parametric equivalent will be used (Wilcoxon rank sum). Mixed model ANOVA will be used to determine significance between group and within the group for each time point. Sample size was calculated from the pilot study strength data. Based on effect sizes observed in a pilot study of FES use (Pool et al., 2014), a one tailed alpha of 0.05 and power of 80% power analysis suggested that each group required at least 15 participants to identify a change of 6 heel raises, the least change considered clinically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/06/2013
Actual
7/06/2013
Date of last participant enrolment
Anticipated
26/07/2013
Actual
26/07/2013
Date of last data collection
Anticipated
Actual
31/03/2014
Sample size
Target
30
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 2908 0
Princess Margaret Hospital - Subiaco

Funding & Sponsors
Funding source category [1] 289826 0
Charities/Societies/Foundations
Name [1] 289826 0
Princess Margaret Hospital Foundation
Country [1] 289826 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
School of Sport Science Exercise and Health
35 Stirling Highway Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 288518 0
Hospital
Name [1] 288518 0
Princess Margaret Hospital
Address [1] 288518 0
Roberts Road, Subiaco 6008 WA
Country [1] 288518 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291559 0
Princess Margaret Hospital Ethics and Research Governance
Ethics committee address [1] 291559 0
Roberts Road Subiaco WA 6008
Ethics committee country [1] 291559 0
Australia
Date submitted for ethics approval [1] 291559 0
Approval date [1] 291559 0
24/05/2013
Ethics approval number [1] 291559 0
2013041EP
Ethics committee name [2] 291560 0
University of Western Australia - Research Ethics and Biosafety Office Research Services
Ethics committee address [2] 291560 0
35 Stirling Highway Crawley 6009 WA
Ethics committee country [2] 291560 0
Australia
Date submitted for ethics approval [2] 291560 0
Approval date [2] 291560 0
05/07/2013
Ethics approval number [2] 291560 0

Summary
Brief summary
To determine the effects of community applied functional electrical stimulation in ambulant children with unilateral spastic cerebral palsy. A device known as the Walk Aide will be given to the intervention group to wear daily for a period of 8 weeks. This controlled trial will determine the effects of using such a device on a range of outcome measures covering the International Classification of Functioning (child and youth version). The outcome of this trial will deepen our understanding of the effects of functional electrical stimulation in a paediatric population and shape our clinical recommendations based on the available evidence.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50882 0
Mrs Dayna Pool
Address 50882 0
Princess Margaret Hospital
Department of Physiotherapy and Paediatric Rehabilitation
Level 5, Hay Street Subiaco 6008 WA
Country 50882 0
Australia
Phone 50882 0
+61893408503
Fax 50882 0
Email 50882 0
Dayna.Pool@health.wa.gov.au
Contact person for public queries
Name 50883 0
Mrs Dayna Pool
Address 50883 0
Princess Margaret Hospital
Department of Physiotherapy and Paediatric Rehabilitation
Level 5, Hay Street Subiaco 6008 WA
Country 50883 0
Australia
Phone 50883 0
+61893408503
Fax 50883 0
Email 50883 0
Dayna.Pool@health.wa.gov.au
Contact person for scientific queries
Name 50884 0
Mrs Dayna Pool
Address 50884 0
Princess Margaret Hospital
Department of Physiotherapy and Paediatric Rehabilitation
Level 5, Hay Street Subiaco 6008 WA
Country 50884 0
Australia
Phone 50884 0
+61893408503
Fax 50884 0
Email 50884 0
Dayna.Pool@health.wa.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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe orthotic and therapeutic effects following daily community applied functional electrical stimulation in children with unilateral spastic cerebral palsy: A randomised controlled trial.2015https://dx.doi.org/10.1186/s12887-015-0472-y
EmbaseNeuromuscular electrical stimulation-assisted gait increases muscle strength and volume in children with unilateral spastic cerebral palsy.2016https://dx.doi.org/10.1111/dmcn.12955
N.B. These documents automatically identified may not have been verified by the study sponsor.