Cerebral palsy Nervous System Diseases Cerebral palsy
Conditions
Interventions
ROBUST 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
12 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Adolescents aged 12-18 years (i.e. from their 12th to their 18th birthday) 2. Diagnosis of spastic CP (bilateral or unilateral) Gross Motor Function Classification System (GMFCS) levels I–III 3. Willing for their community physiotherapy service and GP to be informed of their participation in the trial 4. Under 16 years of age: Participant is willing to take part in the study and has a parent/guardian who is willing and able to give informed consent for the child’s participation in the study. 5. Over 16 years of age: Participant is willing and able to give informed consent or a nominated Consultee can advise on behalf of the participant (Outside Scotland)/legal representative can consent on the participant's behalf (Scotland)
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 resistance exercise programme focused on resistance training as part of their usual physiotherapy routine 4. Patient is unable to comply with the assessment procedures and exercise programme with or without support from their carer
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. Muscle strength measured using the five time sit-to-stand test for adolescents with CP 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, Wales
Outcome results
None listed