Clinical effectiveness of an adolescent-specific strengthening programme, compared to usual care, for ambulant adolescents with spastic cerebral palsy - the ROBUST trial
A strengthening programme tailored for each adolescent with cerebral palsy is being tested against usual NHS care in a trial involving 334 teenagers across at least 12 UK hospitals. This matters because adolescents with spastic cerebral palsy often lose muscle strength and mobility as they grow, yet there is no clear evidence that the resistance exercises commonly prescribed by physiotherapists actually improve their day-to-day function. The ROBUST trial directly compares a structured 16-week strengthening programme with whatever care patients would normally receive, measuring functional mobility at six months using a questionnaire validated specifically for this group. If the programme proves effective, it could give clinicians a proven, standardised approach to preserving independence and mobility during a critical developmental window. For adolescents, that might mean better balance, less pain, and greater participation in school and social activities. For the NHS, it would replace guesswork with an evidence-based intervention, potentially reducing the need for later surgeries or assistive devices. The trial also tracks school attendance to ensure the programme does not inadvertently harm educational outcomes.
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OBJECTIVE: To assess the clinical effectiveness of a strengthening programme compared to usual care for ambulant adolescents 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: Adolescents aged 12-18 years with a diagnosis of spastic CP (bilateral or unilateral) (4) 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 injections or serial casting in the past 4 months; are currently performing a resistance 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 strengthening programme, including structured resistance exercises and advice, overseen by a physiotherapist over 16 weeks, or 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 (5). 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 muscle strength and motor function at 6 months (blinded clinician assessed five-time sit-to-stand test for adolescents with CP (1) and Timed up and Go test (3)). 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) (6), educational outcomes (school attendance record to ensure this is not reducing as a result of the intervention), exercise adherence and AE’s related to intervention.
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