Clinical effectiveness of a child-specific dynamic stretching exercise programme, compared to usual care, for ambulant children with spastic cerebral palsy - the SPELL trial.
Children with cerebral palsy who can walk are being asked to stretch—but no one knows if the specific type of stretching they are told to do actually improves their mobility. The problem is that current care for these children varies widely. Physiotherapists often prescribe stretching exercises, but there is no strong evidence that the dynamic stretching programmes commonly recommended are any better than simply continuing with whatever therapy the child already receives. Without a large, well-designed trial, clinicians and families are left guessing. This trial will recruit 334 children aged 4–11 across at least 12 NHS trusts. Half will receive a tailored 16-week dynamic stretching programme overseen by a physiotherapist; the other half will continue with usual care. The key measure is functional mobility at six months, using a questionnaire validated specifically for children with cerebral palsy. If the stretching programme proves superior, it would give the NHS a clear, evidence-based treatment option for improving how these children move in daily life. If it does not, it would spare families and the health service from investing time and resources in an ineffective intervention. Either way, the result will directly inform clinical guidelines for one of the most common childhood physical disabilities.
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Objective: To assess the clinical effectiveness of a dynamic stretching programme compared to usual care for ambulant children with spastic cerebral palsy (CP). Design: Two-group, pragmatic, superiority, parallel group, multicentre randomised controlled trial with an imbedded internal pilot. Setting: 334 participants identified through the Cerebral Palsy Integrated Pathway (CPIP) , and recruited from at least 12 UK NHS Trusts. Target population: Children aged 4-11 years with a diagnosis of spastic CP (bilateral or unilateral) (8) GMFCS levels I–III who are able to comply with assessment procedures and exercise programme with or without support by their carer. Participants will be excluded if they: have had orthopaedic surgery of the lower limbs or selective dorsal rhizotomy in the past 12 months; had botulinum toxin injections or serial casting in the past 4 months; are currently performing a dynamic stretching exercise programme; are unable to comply with assessment procedures and exercise programme with or without support by their carer. Health technologies assessed: The participant will be randomised to either 1) an individually tailored dynamic stretching programme, including exercises and advice, overseen by a physiotherapist over 16 weeks, or 2) usual care. Measurement of outcome: Follow-up will be by face to face assessment at 6 months and web-based questionnaire (or postal, if requested) at 12 months. The primary outcome is functional mobility at 6 months measured using the patient/parent reported GOAL (Gait Outcomes Assessment List) questionnaire (9). The GOAL is validated specifically for use in ambulant CP and is internationally accepted as the appropriate functional outcome measure for lower limb interventions in this population. Secondary outcomes include joint range of motion and motor function at 6 months (blinded clinician assessed Timed up and Go test (10) and CPIP (5) joint range of motion recording). At 6 and 12 months functional mobility (GOAL), independence (GOAL subdomain A), balance (GOAL subdomain A,B,D), pain and discomfort (GOAL subdomain C), quality of Life (EQ-5D-Y) (11), educational outcomes (school attendance record to ensure this is not reducing as a result of the intervention), exercise adherence and Adverse Events related to intervention.
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