Strengthening programme for ambulant adolescents with cerebral palsy

Not Applicable

• Conditions: Cerebral palsy; Nervous System Diseases

• Registration Number: ISRCTN68282588
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-08-01
• Last Update Posted: 25 March 2024
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 334

Inclusion Criteria

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)

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional mobility measured using the patient/parent-reported Gait Outcomes Assessment List (GOAL) questionnaire at 6 months

Secondary Outcome Measures

Name	Time	Method
1. Muscle strength measured using the five time sit-to-stand test for adolescents with CP at 6 months<br>2. Motor function measured using the Timed Up and Go (TUG) test at 6 months<br>3. Functional mobility measured using the patient/parent-reported Gait Outcomes Assessment List (GOAL) questionnaire at 12 months <br>4. Independence measured using GOAL subdomain A at 6 and 12 months<br>5. Balance measured using GOAL subdomains A, B, D at 6 and 12 months<br>6. Pain and discomfort measured using GOAL subdomain C at 6 and 12 months<br>7. Health-related quality of life measured using EQ-5D-Y at 6 and 12 months <br>8. Educational outcomes measured using educational attendance records (days) at 6 and 12 months<br>9. Patient/parent exercise adherence self-reported at 6 and 12 months<br>10. Additional physiotherapy treatment self-reported at 6 and 12 months