This project will investigate the impact of a physiotherapy+WalkAide® intervention for children aged 6-17 years old with hemiplegic cerebral palsy (CP). We will learn whether this type of therapy can improve skills like running, jumping and balance, and whether it can help children become more active. We know how the WalkAide works and that it is safe for children to use. We also know that it doesn’t work for all young people with CP. We don’t know if having physiotherapy when using the WalkAide will be any better than physiotherapy alone. This project will help us to find out!
Research aims
The aims of this project are to:
- Investigate whether four specialised physiotherapy sessions + WalkAide use can improve advanced motor skills (e.g. running, jumping, balance) and physical activity participation.
- Find out whether the physiotherapy+WalkAide intervention is better than physiotherapy alone.
- Ask children and their family what they think about using the WalkAide. Do they think it works? Is it easy to use? Are they happy to wear it?
- Develop clinical guidelines for WalkAide use, informed by the experiences of physiotherapists and orthotists who take part in the project.
Background
Many children with cerebral palsy (CP) have weakness or spasticity in their lower leg muscles. This can cause poor clearance of their feet when walking and running, and children often use a brace or orthotic to prevent trips and/or falls. The brace often blocks or restricts ankle movements, impacting on speed or agility, and necessitates larger footwear to accommodate the extra width.
The WalkAide is a small unit that straps around the leg, just under the knee, replacing the need for a brace. This means the child can use any footwear and even go barefoot. The WalkAide also allows for greater freedom in movement and, unlike a brace, does not need to be replaced as the child grows. In contrast to existing orthotics, the WalkAide activates weak muscles of the lower leg through electrical stimulation and can promote a more natural, balanced, and efficient walking pattern.
The WalkAide system has been used extensively to improve walking ability of adults with foot drop. We know that in children with CP, short-term use of the WalkAide can increase muscle size and improve a child’s walking pattern. Research also suggests that the WalkAide may be more acceptable to wear than a traditional orthotic. It is possible that at least some of the beneficial changes in walking pattern could be maintained for several weeks without ongoing use of the device, giving children a break from ‘looking different’. Currently, most children and young people who could benefit from using a WalkAide are not able to access the device due to the high cost of the unit and limited evidence for its effectiveness.
Novita has begun a program of research to explore whether beneficial changes in walking pattern translate to increased physical activity participation and/or achievement of a child’s participation goals. We are also interested to find out how well children and families manage with the WalkAide in everyday life, as well as the clinical utility of the device.
Participants
40 Novita clients will be recruited for the study.
Inclusion criteria:
- Age 6 to 17 years
- A diagnosis of hemiplegic CP, GMFCS I/II (walk/run without a walking device other than ankle brace)
- Passive ankle dorsiflexion range with knee extension of affected ankle of greater than plantargrade
- Score of >1 on the Selective Motor Control of dorsiflexion
- Knee flexion contracture of less than 10* flexion
- Able to cognitively understand the interventions and commit to the program and assessment sessions.
Exclusion criteria:
- Where dystonia is primary contributor to the movement disorder
- Skin allergies or reactions to adhesives/silicon
- Lower limb botulinum toxin in last three months
- Orthopaedic surgery in last 12 months
- Orthopaedic metalware around the knee and leg
- Uncontrolled seizure disorder.
Method
Recruitment Steps: Potentially eligible clients will receive a study information letter. Those interested will attend a screening assessment. Children who meet criteria and consent will undergo baseline assessment and be randomly allocated to the physiotherapy+WalkAide group or the physiotherapy group.
Procedures: Participants will be attend three assessment sessions at Novita’s Regency Park office over four months and have four motor learning, gait focused physiotherapy sessions.
Co-primary outcomes:
- The Challenge-20 will evaluate advanced gross motor abilities related to walking/running/jumping.
- The Canadian Occupational Performance Measure (COPM) will provide child/parent scores for children’s individual physical activity/participation goal achievement.
ANZCTR trial ID: ACTRN12616000701426. For more information please click here.
Potential outcomes and implications?
For children and families
Our feasibility study results suggest that specialised physiotherapy sessions alone are associated with an improvement in gross motor skills and physical activity participation, independent of WalkAide use. Participants and families commented that the use of engaging outcome measures, such as the Challenge 20, and the content of the physiotherapy sessions helped to make taking part in the project a positive and enjoyable experience. Funding priorities dictate that high functioning young people with cerebral palsy may not receive intensive intervention. Feedback from families, as well as from physiotherapists, indicated that they very much valued this opportunity to have increased physiotherapy input.
Based on learnings from our feasibility work, we have refined the inclusion and exclusion criteria and WalkAide acclimatisation protocol for this study to optimise the potential for success. Many participants in the physiotherapy+WalkAide group are expected to prefer the WalkAide to their previous orthotic management and enjoy having additional control of the device. Our feasibility study also suggested that WalkAide use will encourage participants to take increased responsibility for management of their disability. The overall results of this research are expected to inform best practice intervention for children and young people in this population..
For professionals
Results of this study will inform best practice in WalkAide prescription for this group (including a profile of clients for whom the device is best suited) and development of clinical guidelines for optimal WalkAide use. Long term, results will ensure optimum outcomes for clients and improved efficiency for Novita and other organisations. Results will also provide evidence for future WalkAide prescription to inform funding e.g. from National Disability Insurance Scheme.
Research team
Chief investigator
Kerry Evans, Profession Leader, Physiotherapy, Knowledge & Innovation, Novita Children’s Services
Associate Investigators
Dr Annemarie Wright, Research Officer, Knowledge & Innovation, Novita Children’s Services
Lisa Dodds, Senior Orthotist, Assistive Technology Service, Novita Children’s Services
A/Prof Virginia Wright, Senior Scientist, Holland Bloorview Kids Rehabilitation Hospital, Bloorview Research Institute
Contact person
Annemarie Wright
(08) 8243 8281
[email protected]