Clinical effectiveness of a child-specific dynamic stretching programme, compared to usual care, for ambulant children with spastic cerebral palsy (SPELL trial): a parallel group randomised controlled trial
Cerebral palsy
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 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. Children and their parent(s) will be approached as part of their annual community physiotherapy CPIP review or other routine CP clinical care attendance and/or will be sent letters with study information. 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 demographic questions for eligible patients and detail any reasons given for exclusion and non-participation. Participants will be asked to sign an assent form whilst the parent/carer will be asked to sign a consent form on behalf of their child. 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/carer will be asked to complete a baseline assessment questionnaire, which will include baseline measurements for the primary and secondary outcomes. Clinician-assessed outcomes (ie passive range of lower limb joint motion 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 database (REDCap). Those randomly allocated to the dynamic stretching exercise programme will receive six physiotherapy sessions over 16 weeks and will be requested to complete follow-up questionnaires via a link in an email or by paper through the post at 6 and 12 months. Clinician-assessed outcome
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
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