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

niversity of Oxford0 sites334 target enrollmentAugust 1, 2023

Overview

No summary available.

Registry

who.int

Start Date

August 1, 2023

End Date

September 1, 2026

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•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