About this trial
This pilot study investigates whether walking training using cruro-malleolar casts (CMCs) - rigid leg splints extending from the thigh to the ankle - can safely improve gait quality in children with bilateral cerebral palsy (CP). CMCs are already used in routine clinical care at our center, but their biomechanical effects and therapeutic value have never been formally studied.Children aged 7 to 14 with bilateral spastic CP (diplegia or quadriplegia, GMFCS levels I-III) will participate in a 4-week treadmill walking program wearing CMCs, preceded by a 1-month observation baseline and followed by a 6-month follow-up. The investigators will use motion capture technology and surface electromyography to measure how the CMCs immediately change the way children walk - particularly at the hip and pelvis - and whether the training program leads to lasting improvements in walking speed, quality, and endurance.The study also carefully monitors pain and effort perceived by children during each training session, so that tolerance of the intervention can be rigorously assessed. Six participants will be enrolled. The study uses a Single-Case Experimental Design (SCED), which allows rigorous conclusions to be drawn from a small number of patients through repeated measurements over time.
Eligibility criteria
Qualifiers
Children aged 7 to 14 years
Pubertal development at Tanner stage 1 or 2
Bilateral cerebral palsy (diplegia or quadriplegia)
Ambulatory with or without assistive device (GMFCS levels I, II, or III)
Disqualifiers
Pubertal development at Tanner stage greater than 2
Refusal to wear cruro-malleolar casts (CMCs)
Inability to walk on a treadmill
Refusal to participate in the repeated assessment sessions required by the study protocol
Trial design
Treatments tested in this trial
- Cruro-Malleolar Cast Walking Training