Strengthening programme for ambulant adolescents with cerebral palsy
| ISRCTN | ISRCTN68282588 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68282588 |
| IRAS number | 325313 |
| Secondary identifying numbers | CPMS 57227, IRAS 325313 |
- Submission date
- 12/07/2023
- Registration date
- 01/08/2023
- Last edited
- 06/03/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nervous System Diseases
Plain English Summary
Background and study aims
Cerebral palsy (CP) is caused when babies suffer brain injury around birth from a lack of oxygen in the brain. Children with CP develop stiff and weak muscles. They often have difficulty walking and moving and that makes it difficult for them to join in activities. Exercises prescribed by physiotherapists become a big part of their lives as it tries to train their muscles and help them participate in activities. When they reach adolescence and their body grows, weakness of muscles in the legs becomes more of a problem.
Exercises to strengthen muscles to maintain or improve movement are often used by physiotherapists in adolescents with CP. However, there is wide variability in the strengthening exercise programmes used. Therefore, professional groups have highlighted the need for evidence-based physiotherapy exercise programmes in adolescents with CP. The aim of this study is to assess the effectiveness of a strengthening programme compared to usual care in adolescents with CP.
Who can participate?
Adolescents aged 12-18 years with spastic cerebral palsy
What does the study involve?
Participants will be randomly allocated into either the intervention (exercise programme) group or the usual NHS physiotherapy group. The intervention will involve six sessions with the physiotherapist over 16 weeks. Adolescents will receive an exercise programme which includes specific individually tailored strengthening exercises. The usual care group will receive the usual NHS physiotherapy treatment, involving one session to receive advice and guidance on their usual exercise and activity programme but does not include specific strengthening exercises. Adolescents or their parents/guardians in both groups will be required to fill out a questionnaire when entering the study and again at 6 and 12 months. Participants will also receive a clinical assessment upon entering the study and again at 6 months.
What are the possible benefits and risks of participating?
As with any form of exercise, adolescents may experience delayed muscle soreness on movement and/or mild altered walking (limping) for a few days after completing some of the exercises suggested by the physiotherapist. The benefit of participating is that the information from this study will be used to help treat other adolescents with CP more effectively.
Where is the study run from?
The study will be centrally managed by the Surgical Intervention Trials Unit (SITU), in collaboration with the Oxford Clinical Trials Unit (OCTRU) (UK)
When is the study starting and how long is it expected to run for?
January 2023 to September 2027
Who is funding the study?
National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) Programme (UK)
Who is the main contact?
1. Sally Hopewell, sally.hopewell@csm.ox.ac.uk
2. Joanna O’Mahoney, joanna.omahoney@ndorms.ox.ac.uk
Contact information
Scientific
Surgical Intervention Trials Unit
The Botnar Research Centre
Windmill Road
Oxford
OX3 7LD
United Kingdom
| Phone | +44 (0)1865 737643 |
|---|---|
| joanna.omahoney@ndorms.ox.ac.uk |
Principal Investigator
University of Oxford
Botnar Institute for Musculoskeletal Sciences
Windmill Road
Oxford
OX3 7LD
United Kingdom
 ORCID ID |
0000-0002-6881-6984 |
|---|---|
| Phone | +44 (0)1865 223458 |
| sally.hopewell@csm.ox.ac.uk |
Study information
| Study design | Randomized; Interventional; Design type: Treatment, Physical, Rehabilitation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Study type | Participant information sheet |
| Scientific title | 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 |
| Study acronym | ROBUST |
| Study hypothesis | An adolescent-specific muscle strengthening programme has superior clinical effectiveness compared to usual care for ambulant adolescents with spastic cerebral palsy. |
| Ethics approval(s) | Approved 30/08/2023, South Central - Hampshire A Research Ethics Committee (Health Research Authority, 2 Redman Place, Stratford, London, E20 1JQ, UK; +44 (0)207 104 8388; hampshirea.rec@hra.nhs.uk), ref: 23/SC/0231 |
| Condition | Cerebral palsy |
| Intervention | ROBUST 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. Adolescents and their parent(s) will be approached as part of their annual community physiotherapy CPIP review or other routine CP clinical care attendance. 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 questions on patient demographics and detail any reasons given for exclusion and non-participation. Participants will be asked to sign an assent form (for adolescents aged 12-15 years) whilst the parent/guardian will be asked to sign a consent form on behalf of their child. For those aged 16-18 years when entering the study, the young person will either be asked to sign a consent form or, if the clinician assesses the young person to be unable to provide informed consent, their parent/guardian (or other relative/friend, if applicable) will be asked to complete a consultee declaration on their behalf. 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/guardians will be asked to complete a baseline assessment questionnaire, which will include baseline measurements for the primary and secondary outcomes. Clinician-assessed outcomes (i.e. muscle strength 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 progressive resistance 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 outcomes will be assessed at a face-to-face clinic appointment at 6 months by a blinded physiotherapist/assistant practitioner who is blind to the treatment allocation and has not been involved in the delivery of the intervention or usual care. Those randomly allocated to the usual NHS care arm will receive one session of usual care advice, with a physiotherapist/assistant practitioner. Participants allocated to this group will also be sent a link via email or a paper copy of the questionnaires to complete at 6 months and 12 months. They will also receive a blinded clinician assessment at the 6-month timepoint. |
| Intervention type | Behavioural |
| Primary outcome measure | Functional mobility measured using the patient/parent-reported Gait Outcomes Assessment List (GOAL) questionnaire at 6 months |
| Secondary outcome measures | 1. Muscle strength measured using the five time sit-to-stand test for adolescents with CP at 6 months 2. Motor function measured using the Timed Up and Go (TUG) test at 6 months 3. Functional mobility measured using the patient/parent-reported Gait Outcomes Assessment List (GOAL) questionnaire at 12 months 4. Independence measured using GOAL subdomain A at 6 and 12 months 5. Balance measured using GOAL subdomains A, B, D at 6 and 12 months 6. Pain and discomfort measured using GOAL subdomain C at 6 and 12 months 7. Health-related quality of life measured using EQ-5D-Y at 6 and 12 months 8. Educational outcomes measured using educational attendance records (days) at 6 and 12 months 9. Patient/parent exercise adherence self-reported at 6 and 12 months 10. Additional physiotherapy treatment self-reported at 6 and 12 months |
| Overall study start date | 01/01/2023 |
| Overall study end date | 01/09/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 12 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 334; UK Sample Size: 334 |
| Participant 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) |
| Participant 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 |
| Recruitment start date | 29/01/2024 |
| Recruitment end date | 01/03/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
- Wales
Study participating centres
Poole Hospital
Longfleet Road
Poole
BH15 2JB
United Kingdom
Kingsway Hospital
Kingsway
Derby
DE22 3LZ
United Kingdom
1010 Pioneer Avenue
Gloucester Business Park
Gloucester
GL3 4AW
United Kingdom
Eaton Road
West Derby
Liverpool
L12 2AP
United Kingdom
Highpoint Venue
Bursledon Road
Southampton
SO19 8BR
United Kingdom
Parkhurst Road
Newport
PO30 5TG
United Kingdom
80 Newark Street
London
E1 2ES
United Kingdom
Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom
Millshaw Park Lane
Leeds
LS11 0DL
United Kingdom
Hardwick Lane
Bury St. Edmunds
IP33 2QZ
United Kingdom
Wolverhampton Road
Heath Town
Wolverhampton
WV10 0QP
United Kingdom
Stott Lane
Salford
M6 8HD
United Kingdom
Newton Road
Torquay
TQ2 7AA
United Kingdom
Leighton
Crewe
CW1 4QJ
United Kingdom
London
N7 6LB
United Kingdom
Oxford
OX3 7JX
United Kingdom
Kempston
MK42 7EB
United Kingdom
Rhyl
LL18 3RF
United Kingdom
Sponsor information
University/education
Research Governance, Ethics & Assurance Team
Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7GB
England
United Kingdom
| Phone | +44 (0)1865 616494 |
|---|---|
| rgea.sponsor@admin.ox.ac.uk | |
| Website | http://www.ox.ac.uk/ |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/09/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publication and dissemination of trial results and associated trial publications (e.g. the trial protocol, statistical analysis plan (SAP) will be in accordance with OCTRU Standard Operating Procedures and irrespective of trial findings. The findings from the trial will inform NHS clinical practice for the management of ambulant children with spastic CP. The trial protocol will be available via the NIHR HTA website and published in an open-access peer-reviewed journal in accordance with the SPIRIT Statement (https://www.spirit-statement.org/). The trial results will be published in a high-impact open-access journal, in accordance with the NIHR’s policy on open-access research and reported following the CONSORT guideline (https://www.consort-statement.org). All trial materials, including the physiotherapist training materials and high-quality patient advice materials, will be made freely available via the trial website. Prior to formal publication, the researchers will inform the children and their parent(s)/guardian(s) of the trial results using explainer videos and infographics to support written information. The participants will be asked how they would like to be informed of the trial results as part of their original consent process. Patient and Public Involvement representatives will help inform how best to disseminate the trial results to other young people with CP and to the wider public. The researchers will also host an Investigator Day to feed the trial results back to the physiotherapists and other members of the team at the trial sites. They will link with the CPIP network, the British Society for Children’s Orthopaedic Surgery, the British Academy of Childhood Disability, and the Association of Paediatric Chartered Physiotherapists to ensure the results are communicated to all relevant professionals. |
| IPD sharing plan | Upon completion of the trial, and with appropriate participant consent, anonymised research data will be shared with other organisations on request to the Chief Investigator Sally Hopewell (sally.hopewell@csm.ox.ac.uk) and in accordance with the data sharing policies of OCTRU, the Sponsor and funder. Requests for data (anonymised trial participant level data) will be provided at the end of the trial to external researchers who provide a methodologically sound proposal to the trial team (and who will be required to sign a data sharing access agreement with the Sponsor) and in accordance with the NIHR guidance. After the end of the trial an anonymised trial dataset will be created and stored, and may be shared with other researchers upon request. Participant consent for this is included in the informed consent form for the trial. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.0 | 15/06/2023 | 05/09/2023 | No | No |
| Participant information sheet | 10/12/2024 | No | Yes | ||
| Protocol file | version 2.0 | 21/11/2023 | 10/12/2024 | No | No |
Additional files
Editorial Notes
06/03/2025: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/03/2025 to 01/03/2026.
2. The overall end date was changed from 01/09/2026 to 01/09/2027.
3. The study participating centres Whittington Health NHS Trust, Oxford Health NHS Foundation Trust, Bedfordshire Hospitals NHS Trust, Betsi Cadwaladr University Health Board were added.
10/12/2024: The following changes were made to the study record:
1. Protocol uploaded.
2. St George’s University Hospitals NHS Foundation Trust, Leeds Community Healthcare NHS Trust, West Suffolk NHS Foundation Trust, The Royal Wolverhampton NHS Trust, Bury Manchester (Northern Care Alliance NHS FT), Torbay and South Devon NHS Foundation Trust and Mid Cheshire Hospital NHS Foundation Trust were added to the study participating centres.
3. Study website and participant information sheet added.
13/03/2024: The following changes were made to the study record:
1. The recruitment start date was changed from 01/09/2023 to 29/01/2024.
2. University Hospitals Dorset NHS Foundation Trust, Derbyshire Healthcare NHS Foundation Trust, Gloucestershire Health & Care NHS Foundation Trust, Alder Hey Children’s NHS Foundation Trust, Solent NHS Trust, Isle of Wight NHS Trust and Barts Health NHS Trust were added to the study participating centres.
05/09/2023: The following changes were made to the trial record:
1. Uploaded protocol (not peer-reviewed) as an additional file.
2. The ethics approval was added.
12/07/2023: Study's existence confirmed by the NIHR.
