Activity Boost Challenge: Impact of the WalkAide (Registered trademark) device plus physiotherapy on walking and physical activity in children with hemiplegic cerebral palsy.

WalkAide+physio intervention: Physical/informational materials: WalkAide device: WalkAide is a class II, FDA cleared medical device, designed to improve walking ability in people experiencing foot drop caused by upper motor neuron injuries or conditions such as cerebral palsy. The WalkAide set up consists of a AA battery-operated, single-channel electrical stimulator, two electrodes, and electrode leads. WalkAide is a small unit that is worn around a child’s leg, just below the knee, held in place by a cuff. WalkAide uses functional electrical stimulation and tilt sensor technology to analyse the movement of the leg and activate the weak muscles of the leg that pull the foot up. It can be used instead of an Ankle Foot Orthotic or other orthotic or brace and has been shown to improve a child’s walking pattern. WalkAide wear time is recorded by the WalkAide device and will also be monitored by questions asked during four short (5 minute) telephone calls made to the child by a member of the research team each fortnight. These calls will be made to participants in both groups, and will also ask about adherence to the physiotherapy home program. MLGF physiotherapy sessions: Four 45 minute sessions provided fortnightly (weeks 1, 3, 5, and 7). Treatment components are selected to be in line with the child’s and parent’s goals (as articulated in the Canadian Occupational Performance Measure, co-primary outcome measure). Examples of the intervention include balance/stability work, functional strengthening, gait training, endurance/fitness, and advanced motor skill practice. The length of time spent within each area is at the discretion of the treating physiotherapist. The focus can be entirely on one area or be a mix of many areas. Physiotherapists may not use additional electrical stimulation or kinesiotape. Basic stretching, if required, is done in addition to the active intervention protocol, and is not counted in the 45 minute total. Each intervention session is documented by the physiotherapist to describe the activity involved, duration, focus of activity (e.g. balance) and whether the activity was used with the WalkAide on or off (if appropriate). A register of attendance at MLGF physiotherapy sessions will be kept for each child by the treating physiotherapist, who will also document their reported adherence with the home program. Home physiotherapy program: The treating physiotherapist will select 2-4 exercises that have been completed in the session for the child to practice at home. The program is intended to be practiced daily - duration will depend on the activities prescribed but is intended to be around 10 minutes/day. Additional resources provided: WalkAide user guide and wear time schedule, activity monitor user guide. Procedures: The WalkAide+physio group start with a 4-week WalkAide acclimatisation period with two or more orthotic visits to re-evaluate WalkAide parameters, ensure comfort/setting optimization, and if required, custom-fit a foot orthotic (FO). The first two appointments will be with the study orthotist (60 minutes each); appointments three and four will be with the orthotist or with trained paediatric physiotherapists (30-45 minutes each). The number of visits will be determined as required based on child's progress in acclimatising to the use of the WalkAide, as decided by the treating orthotist. The aim is to increase daily WalkAide wear time as tolerated, aiming for >6 hours/day. Children will then embark on an 8-week intervention consisting of: i) WalkAide wear (targeted as by others to be >6 hours/day but actualized as at least the maximum time the child reached at the end of the 4-week acclimatization); ii) four motor learning, gait focused (MLGF) physiotherapy sessions (45 minutes every two weeks) that will emphasize dorsiflexor activation whilst working on advanced motor skills linked to child/parent(s)/guardian(s) identified individualized goals; (iii) physiotherapy home program. WalkAide settings & elicited movement will be checked and documented each session by the physiotherapist, who will email the orthotist if any adjustments are required (changes documented) as needed. After the 8-week wear period, the child and parent will be given the opportunity to be interviewed by a researcher to discuss their experience with the intervention. Participants will return the WalkAide at this point but keep working on their individualized goals over the 4-week follow-up (no further physiotherapy sessions). They will continue to wear the FO provided with the WalkAide unless parent(s)/guardian(s)/child wish to return to their previous orthotic (if they had one) at any time during the 4-week follow-up. Any orthotic changes and reasons will be documented (e.g., tripping/falls, ankle weakness). Loss of ankle dorsiflexion range of motion beyond baseline value will prompt return to their previous orthotic or to a new prescription. The 4-week follow-up assessment will occur in whatever orthosis they are wearing at that time. Assessments will occur at baseline, within 5 days post-intervention, and at 4-week follow-up. Individual semi-structured interviews (30-60 minutes) will occur with a purposive sample of eight children/parent(s)/guardian(s) in the WalkAide+physio intervention to explore their experience, adherence to study protocols, and feelings about ongoing use. Families will be chosen (invited post-intervention) to provide a range of experiences across age and gender of child, WalkAide wear time, previous orthotic use, and physical activity participation. Physiotherapists and orthotists will have the option of being interviewed to discuss the perceived clinical utility after their involvement with each participant ends. Personnel: Eligibility assessment - Paediatric physiotherapist with 25 years experience working in disability. Assessment sessions - Paediatric physiotherapists with at least 5 years experience working in disability and who have completed relevant training. WalkAide fitting and fine-tuning - Senior Orthotist with at least 10 years experience working in paediatric disability field. WalkAide fine-tuning - Paediatric physiotherapists with at least 5 years experience working in disability field and in gait rehabilitation. Physiotherapy sessions - Paediatric physiotherapists working in the disability field and who have completed relevant training. Interviews - PhD qualified researcher. Mode of delivery: Face-to-face and individualised. Location of intervention: Rehabilitation centre and in the community (e.g. participants' home or other suitable location as appropriate). Blinding of child/parent(s)/guardian(s), treating physiotherapist or orthotist to group is not possible given the nature of the intervention. Intervention fidelity will be assessed as follows: To reduce expectation bias, assessing physiotherapists will be told that children receive different combinations of orthoses and/or WalkAide (which they will be told may be activated or not) through the trial. Four other processes will minimize potential bias. 1) The MLGF physiotherapy program is designed by the child’s study physiotherapist and based on the child’s goals pre-randomization using a manualized, menu-based protocol applied to both groups. 2) As a fidelity check, each session’s content is documented by the physiotherapist and reviewed post-session by the study coordinator. 3) Electrical stimulation of any form is not permitted in the physio-only group (contamination). Other mechanical means of facilitating movement (e.g., kinesiotaping) are not permitted in either group. 4) Both groups may continue ongoing participation in sport or physical activity but must discontinue other active gait-based therapy on enrollment and are not able to commence individualised sports coaching or high intensity training programs. 5) All WalkAide adjustments will be recorded with rationale for the changes.