None listed
Conditions
Brief summary
The primary purpose of this study is to examine the effectiveness of selective percutaneous myofascial lengthening (SPML or PERCS) procedure and 9-month post-surgical functional physiotherapy on gross motor function in children with spastic cerebral palsy, school-aged 5-7 years. SPML procedure is a novel, minimally invasive multilevel surgery, usually combined with alcohol nerve blocks. Functional physiotherapy is a task-specific strength training approach through functional activities with the involvement of family in all rehabilitation procedure. The main study hypothesis is that SPML procedure and functional physiotherapy is more effective in improving gross motor function than the regular physiotherapy care intervention (a mixture of Bobath and functional approaches).
Interventions
Arm 1: selective percutaneous myofascial lengthening (SPML) procedure in lower extremities and a 9-month post-surgical functional physiotherapy.
SPML procedure is performed in each patient by a paediatric orthopaedic surgeon, trained by the developer of SPML procedure (Roy Nuzzo, MD), with more than 17 years of experience with this procedure in cerebral palsy. The SPML is often combined with alcohol nerve blocks.
This technique of lengthening, done under general anesthesia as an outpatient, invo
Arm 1: selective percutaneous myofascial lengthening (SPML) procedure in lower extremities and a 9-month post-surgical functional physiotherapy. SPML procedure is performed in each patient by a paediatric orthopaedic surgeon, trained by the developer of SPML procedure (Roy Nuzzo, MD), with more than 17 years of experience with this procedure in cerebral palsy. The SPML is often combined with alcohol nerve blocks. This technique of lengthening, done under general anesthesia as an outpatient, involves micro-incisions (2-3 mm) in the myofascia, via the skin, lengthening the muscle structure under it. It is performed in the hamstring, adductor and calf muscles. The nerve block is a chemical neurolysis procedure with alcohol injection that is done at the same time as SPML in case of overactive obturator nerve, and consequently intense spasticity of the hip adductors, with the aim of alleviating the scissoring gait and helping the children to move their legs independently. The post-surgical functional physiotherapy is provided by expert paediatric physiotherapists, with multiannual experience in this approach. It begins on the same afternoon of the surgery day based on surgeon's instruction. It includes knee immobilizers during rest time for one week and then only during night sleep; full weight-bearing exercises for the lower limbs. It is a specific strength-training programme via functional activities, for promoting independence and functioning, with the involvement of parents in all therapeutic procedure, for providing opportunities for their child to practice during the day. Patients receive physiotherapy sessions five times weekly for the first 6 weeks and then 2-3 times weekly until the end of 9 months of the study. Decision about the allocation to intervention was taken by the parents according to the family-centred model of the decision making.
Sponsors
Vasileios Skoutelis
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
5 Years to 7 Years
Healthy volunteers
No
Inclusion criteria
Spastic cerebral palsy, Gross Motor Function Classification System (GMFCS) levels II-IV, Normal or good cognitive ability, Hip extensor strength higher than grade 2 via manual muscle testing.
Exclusion criteria
Diagnosis other than cerebral palsy, dystonic or mixed motor disorder Age outside the range Gross Motor Function Classification System (GMFCS) levels I and V, Severe cognitive disorders Botulinum toxin injections within six months before the intervention Previous orthopaedic procedures Need for concomitant osteotomy Hip flexor contracture Hip extensor strength below manual muscle testing grade 3
Outcome results
None listed