Cerebral palsy Nervous System Diseases
Conditions
Interventions
SPELL is a randomised controlled trial with 1:1 allocation. Follow-up assessors will be blinded to the randomisation allocation.
Participants will be identified through the Cerebral Palsy Integrated
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
4 Years to 11 Years
Inclusion criteria
Inclusion criteria: 1. Children 4-11 years (i.e. from their 4th birthday to the day before their 12th birthday) 2. Diagnosis of spastic CP (bilateral or unilateral) GMFCS levels I–III 3. Willing for their community physiotherapy service and GP to be informed of their participation in the trial
Exclusion criteria
Exclusion criteria: 1. Patient has had orthopaedic surgery of the lower limbs or selective dorsal rhizotomy in the past 12 months or planned (i.e. date confirmed) in the next 6 months 2. Patient has had lower limb botulinum toxin injections or serial casting in the past 4 months or planned (i.e. date confirmed) in the next 6 months 3. Patient is regularly performing a structured dynamic exercise programme focused on dynamic stretching as part of their usual physiotherapy routine 4. Patient is unable to comply with the assessment procedures and exercise programme with or without support by their parent/guardian
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional mobility measured using the patient/parent-reported Gait Outcomes Assessment List (GOAL) questionnaire at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Passive joint range of motion measured using the CPIP protocol of lower limb joint range of motion at 6 months 2. Motor function measured using the Timed Up and Go (TUG) test at 6 months 3. Functional mobility measured using the patient/parent-reported Gait Outcomes Assessment List (GOAL) questionnaire at 12 months 4. Independence measured using GOAL subdomain A at 6 and 12 months 5. Balance measured using GOAL subdomains A, B, D at 6 and 12 months 6. Pain and discomfort measured using GOAL subdomain C at 6 and 12 months 7. Health-related quality of life measured using EQ-5D-Y at 6 and 12 months 8. Educational outcomes measured using educational attendance records (days) at 6 and 12 months 9. Patient/parent exercise adherence self-reported at 6 and 12 months 10. Additional physiotherapy treatment self-reported at 6 and 12 months | — |
Countries
England, United Kingdom
Outcome results
None listed