Constraint Induced Movement Therapy for the lower extremity for children with unilateral cerebral palsy - a pilot study

Background: Contstraint Induced Movement Therapy for the Leg (CIMT-Leg) is a type of functional therapy (also known as task-specific training) for children with unilateral cerebral palsy targeting the function of the more-affected lower extremity (leg). Dose: 67 hours, consisting of: (1) 30 minutes goal setting with the child and their caregiver, (2) 6 hours of 1:1 physiotherapy sessions at an intensity of 1 hour per week over 6 weeks, delivered either in-clinic, or as alternating in-clinic and telepractice appointments, (3) Up to 60 hours of structured home practice supervised by the child's caregiver (2 hours per day, 5 days per week over the same 6 week intervention period), (4) 30 minutes goal scoring (COPM) and update of the transfer package (to carry on with post-intervention). Materials: During physiotherapy sessions and home practice time, the child wears a pre-fabricated restraint applied to their less-affected lower extremity (rigid knee immobilizer splint – Jobskin RTW Standard Leg/Arm Gaiter) - sized according to limb length as well as goal. Generally the restraint extends from the groin to the just above the ankle. The home exercise program, developed for each child specifically for this study, is articulated in a written transfer package provided to the child and their caregivers including instructions about how to perform each exercise, accompanied by images/diagrams. The home exercise program is updated weekly. A parent log will be used to record the amount of home practice completed. Delivery mode: 1:1 therapist:child. Interventionists: Registered physiotherapists who have completed a standardized training package in the delivery of CIMT-Leg consisting of 2 hours of lecture material and a written instruction manual. The written instruction manual was developed by Cerebral Palsy Alliance (CPA) in 2017 (updated 2020) for use in clinical practice and will be adapted for this clinical trial. Location: In clinic-sessions will take place at a CPA therapy centre, located across NSW and ACT, Australia. Telepractice sessions will take place with the participant and their caregiver at home, using a either HealthDirect or Microsoft Teams as a telepractice platform. Goal-setting and goal-scoring sessions will take place either at a CPA therapy centre or using telepractice. Structured home practice will take place at the participant's home. Tailoring: Content of therapy sessions will be tailored to the child's goals, abilities, interests and motivation. Common goal activities are likely to include: independent standing, supported forward walking, independent walking, improved static and dynamic postural control in standing, running, stair climbing, hopping/jumping, balancing on one leg, kicking balls etc. Specific exercises applied during the physiotherapy sessions and prescribed for home exercise programs will be designed to target the child's goals by addressing goal limiting factors, starting with part-task practice then incrementally increasing in difficulty towards whole task practice (which may involve removal of the restraint for brief periods). Example exercises: If a child's goal is to "walk up stairs independently and reciprocally without a railing" and their goal limiting factors include: reduced weight shift to the more-affected side (with limited stance time and poor medio-lateral postural control), reduced active hip flexion range of motion, reduced strength of leg extensors, and limited task knowledge, a series of exercises may be as follows: (A) Wearing the restraint 1. Weight shift to the more-affected side on flat ground by transferring toys using the hands and reaching from the less-affected to the more-affected side. 2. As above on unstable surface. 3. Tapping the top of an 8cm step with the more-affected side without holding onto a rail. 4. As above with 16cm step. 5. Stepping up onto an 8cm step with the more-affected side without holding onto a rail. 6. As above with 16cm step. 7. Taking 2 reciprocal steps holding onto a rail. 8. As above - gradually increasing the number of steps. 9. Taking 2 reciprocal steps without holding onto a rail. 10. As above - gradually increasing the number of steps. (B) Without restraint 1. Tapping the top of an 8cm step with the less-affected side, while maintaining the more-affected side in as much extension as possible without holding onto a rail. 2. As above with 16cm step. 3. Stepping up onto an 8cm step with the less-affected side without holding onto a rail. 4. As above with 16cm step. 5. Taking 2 reciprocal steps holding onto a rail. 6. As above - gradually increasing the number of steps. 7. Taking 2 reciprocal steps without holding onto a rail. 8. As above - gradually increasing the number of steps. (C) Adjuncts 1. Verbal and visual feedback appropriate to the child's stage of motor learning, including feedback designed to help the child problem solve the task and internalise the motor planning process. Fidelity: Ongoing support to therapists to maintain fidelity will be provided remotely via teleconference in a group setting for 1 hour every two months through the study period and individual clinical supervision when required. Adherence: Checklists will be used to monitor session attendance. Exercises completed during each therapy session will be recorded in session notes. The parent log will be used to record the amount of home practice completed.