Clinical effectiveness of an adolescent-specific strengthening programme, compared to usual care, for ambulant adolescents with spastic cerebral palsy (ROBUST trial): a parallel group randomized controlled trial
Cerebral palsy
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 Pathway (CPIP) Network and recruited from NHS Trusts, providing care for children and young people with CP, where they will be assessed for eligibility by the clinical team, both supported by the local PI and research team in case of uncertainty. Adolescents and their parent(s) will be approached as part of their annual community physiotherapy CPIP review or other routine CP clinical care attendance. They will have the opportunity at their appointment to ask any questions they have about the study. Screening forms will be completed at each site. These will include questions on patient demographics and detail any reasons given for exclusion and non-participation. Participants will be asked to sign an assent form (for adolescents aged 12-15 years) whilst the parent/guardian will be asked to sign a consent form on behalf of their child. For those aged 16-18 years when entering the study, the young person will either be asked to sign a consent form or, if the clinician assesses the young person to be unable to provide informed consent, their parent/guardian (or other relative/friend, if applicable) will be asked to complete a consultee declaration on their behalf. Randomisation will take place once informed consent has been given, eligibility has been confirmed and baseline assessments have been made. During the baseline assessment participants, with the support of their parent/guardians will be asked to complete a baseline assessment questionnaire, which will include baseline measurements for the primary and secondary outcomes. Clinician-assessed outcomes (i.e. muscle strength and motor function) at baseline will be recorded electronically by a physiotherapist at site and before learning the outcome of the randomisation. All data will be entered into the study databa
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)
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