Clinical effectiveness of an individually tailored strengthening programme, including progressive resistance exercises and advice, compared to usual care for ambulant adolescents with spastic cerebral palsy (ROBUST trial): a parallel group randomized controlled trial
Aims: Muscle strengthening exercises are one of the interventions frequently prescribed by physiotherapists for adolescents with cerebral palsy (CP). However, there is wide variability in the exercise regimes used and limited evidence of their effectiveness. The ROBUST trial will assess the clinica...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
The British Editorial Society of Bone & Joint Surgery
2025-05-01
|
| Series: | Bone & Joint Open |
| Subjects: | |
| Online Access: | https://online.boneandjoint.org.uk/doi/epdf/10.1302/2633-1462.65.BJO-2024-0268 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850216427994218496 |
|---|---|
| author | Sally Hopewell David J. Keene Ioana Marian Daniel C. Perry Ines Rombach Morag Andrew Catherine Barry Loretta Davis Gregory Firth Heidi Fletcher Beth Fordham Vivi Gregory Osborne Helen Gregory Osborne Lesley Katchburian Joanna O'Mahoney Jeremy Parr Rachel Rapson Jennifer Ryan Elnaz Saeedi Megan Stone Helen Wood Tim Theologis |
| author_facet | Sally Hopewell David J. Keene Ioana Marian Daniel C. Perry Ines Rombach Morag Andrew Catherine Barry Loretta Davis Gregory Firth Heidi Fletcher Beth Fordham Vivi Gregory Osborne Helen Gregory Osborne Lesley Katchburian Joanna O'Mahoney Jeremy Parr Rachel Rapson Jennifer Ryan Elnaz Saeedi Megan Stone Helen Wood Tim Theologis |
| author_sort | Sally Hopewell |
| collection | DOAJ |
| description | Aims: Muscle strengthening exercises are one of the interventions frequently prescribed by physiotherapists for adolescents with cerebral palsy (CP). However, there is wide variability in the exercise regimes used and limited evidence of their effectiveness. The ROBUST trial will assess the clinical effectiveness of an individually tailored strengthening programme, including progressive resistance exercises and advice, compared to usual care for ambulant adolescents with spastic CP. Methods: We are conducting a multicentre, two-arm, parallel group, superiority randomized controlled trial. We will recruit adolescents aged 12 to 18 years with a diagnosis of spastic CP (bilateral or unilateral) Gross Motor Function Classification System (GMFCS) levels I to III who are able to comply with the assessment procedures and exercise programme with or without support. Participants will be recruited from at least 12 UK NHS Trust physiotherapy and related services. Participants (n = 334) will be randomized (centralized computer-generated 1:1 allocation ratio) to either: 1) a progressive resistance exercise programme, with six one-to-one physiotherapy sessions over 16 weeks; or 2) usual NHS care, with a single physiotherapy session and an assessment session, and advice regarding self-management and exercise. Conclusion: The primary outcome is functional mobility measured using the child-/parent-reported Gait Outcomes Assessment List (GOAL) at six months. Secondary outcomes are: clinician-assessed muscle strength (Five Times Sit-to-Stand Test) and motor function (timed up and go test) at six months; functional mobility (GOAL) at 12 months; independence (GOAL subdomain A), balance (GOAL subdomain A, B, D), pain and discomfort (GOAL subdomain C), health-related quality of life (youth version of the EuroQol five-dimension questionnaire; EQ-5D-Y), educational attendance, exercise adherence, and additional physiotherapy treatment (six and 12 months). The primary analysis will be intention to treat. Cite this article: Bone Jt Open 2025;6(5):517–527. |
| format | Article |
| id | doaj-art-5d575c78a7884b59b7b9f39ab5d2ad4f |
| institution | OA Journals |
| issn | 2633-1462 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | The British Editorial Society of Bone & Joint Surgery |
| record_format | Article |
| series | Bone & Joint Open |
| spelling | doaj-art-5d575c78a7884b59b7b9f39ab5d2ad4f2025-08-20T02:08:19ZengThe British Editorial Society of Bone & Joint SurgeryBone & Joint Open2633-14622025-05-016551752710.1302/2633-1462.65.BJO-2024-0268Clinical effectiveness of an individually tailored strengthening programme, including progressive resistance exercises and advice, compared to usual care for ambulant adolescents with spastic cerebral palsy (ROBUST trial): a parallel group randomized controlled trialSally Hopewell0David J. Keene1Ioana Marian2Daniel C. Perry3Ines Rombach4Morag Andrew5Catherine Barry6Loretta Davis7Gregory Firth8Heidi Fletcher9Beth Fordham10Vivi Gregory Osborne11Helen Gregory Osborne12Lesley Katchburian13Joanna O'Mahoney14Jeremy Parr15Rachel Rapson16Jennifer Ryan17Elnaz Saeedi18Megan Stone19Helen Wood20Tim Theologis21 Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK University of Exeter, Exeter, UK Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK University of Liverpool, Liverpool, UK School of Medicine and Population Health, University of Sheffield, Sheffield, UK Newcastle upon Tyne NHS Foundation Trust; Newcastle University Population Health Sciences Institute, Newcastle upon Tyne, UK Surgical Interventions Trials Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK Surgical Interventions Trials Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK Maidstone and Tunbridge Wells NHS Trust in Kent, Maidstone, UK Surgical Interventions Trials Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK Surgical Interventions Trials Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK Patient and Public Involvement Representative, London, UK Patient and Public Involvement Representative, London, UK Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK Surgical Interventions Trials Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK Newcastle upon Tyne NHS Foundation Trust; Newcastle University Population Health Sciences Institute, Newcastle upon Tyne, UK Children and Family Health Devon, Torbay and South Devon NHS Foundation Trust, Torquay, UK CP-Life Research Centre, RCSI University of Medicine and Health Sciences, Dublin, Ireland Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK Surgical Interventions Trials Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK Surgical Interventions Trials Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK Aims: Muscle strengthening exercises are one of the interventions frequently prescribed by physiotherapists for adolescents with cerebral palsy (CP). However, there is wide variability in the exercise regimes used and limited evidence of their effectiveness. The ROBUST trial will assess the clinical effectiveness of an individually tailored strengthening programme, including progressive resistance exercises and advice, compared to usual care for ambulant adolescents with spastic CP. Methods: We are conducting a multicentre, two-arm, parallel group, superiority randomized controlled trial. We will recruit adolescents aged 12 to 18 years with a diagnosis of spastic CP (bilateral or unilateral) Gross Motor Function Classification System (GMFCS) levels I to III who are able to comply with the assessment procedures and exercise programme with or without support. Participants will be recruited from at least 12 UK NHS Trust physiotherapy and related services. Participants (n = 334) will be randomized (centralized computer-generated 1:1 allocation ratio) to either: 1) a progressive resistance exercise programme, with six one-to-one physiotherapy sessions over 16 weeks; or 2) usual NHS care, with a single physiotherapy session and an assessment session, and advice regarding self-management and exercise. Conclusion: The primary outcome is functional mobility measured using the child-/parent-reported Gait Outcomes Assessment List (GOAL) at six months. Secondary outcomes are: clinician-assessed muscle strength (Five Times Sit-to-Stand Test) and motor function (timed up and go test) at six months; functional mobility (GOAL) at 12 months; independence (GOAL subdomain A), balance (GOAL subdomain A, B, D), pain and discomfort (GOAL subdomain C), health-related quality of life (youth version of the EuroQol five-dimension questionnaire; EQ-5D-Y), educational attendance, exercise adherence, and additional physiotherapy treatment (six and 12 months). The primary analysis will be intention to treat. Cite this article: Bone Jt Open 2025;6(5):517–527.https://online.boneandjoint.org.uk/doi/epdf/10.1302/2633-1462.65.BJO-2024-0268cerebral palsystrengthening exercisesphysiotherapy trialresistance exercisesrandomized controlled trialphysiotherapistsphysiotherapyexercise programmecliniciansmuscle strengthgross motor function classification systemspastic cerebral palsy |
| spellingShingle | Sally Hopewell David J. Keene Ioana Marian Daniel C. Perry Ines Rombach Morag Andrew Catherine Barry Loretta Davis Gregory Firth Heidi Fletcher Beth Fordham Vivi Gregory Osborne Helen Gregory Osborne Lesley Katchburian Joanna O'Mahoney Jeremy Parr Rachel Rapson Jennifer Ryan Elnaz Saeedi Megan Stone Helen Wood Tim Theologis Clinical effectiveness of an individually tailored strengthening programme, including progressive resistance exercises and advice, compared to usual care for ambulant adolescents with spastic cerebral palsy (ROBUST trial): a parallel group randomized controlled trial Bone & Joint Open cerebral palsy strengthening exercises physiotherapy trial resistance exercises randomized controlled trial physiotherapists physiotherapy exercise programme clinicians muscle strength gross motor function classification system spastic cerebral palsy |
| title | Clinical effectiveness of an individually tailored strengthening programme, including progressive resistance exercises and advice, compared to usual care for ambulant adolescents with spastic cerebral palsy (ROBUST trial): a parallel group randomized controlled trial |
| title_full | Clinical effectiveness of an individually tailored strengthening programme, including progressive resistance exercises and advice, compared to usual care for ambulant adolescents with spastic cerebral palsy (ROBUST trial): a parallel group randomized controlled trial |
| title_fullStr | Clinical effectiveness of an individually tailored strengthening programme, including progressive resistance exercises and advice, compared to usual care for ambulant adolescents with spastic cerebral palsy (ROBUST trial): a parallel group randomized controlled trial |
| title_full_unstemmed | Clinical effectiveness of an individually tailored strengthening programme, including progressive resistance exercises and advice, compared to usual care for ambulant adolescents with spastic cerebral palsy (ROBUST trial): a parallel group randomized controlled trial |
| title_short | Clinical effectiveness of an individually tailored strengthening programme, including progressive resistance exercises and advice, compared to usual care for ambulant adolescents with spastic cerebral palsy (ROBUST trial): a parallel group randomized controlled trial |
| title_sort | clinical effectiveness of an individually tailored strengthening programme including progressive resistance exercises and advice compared to usual care for ambulant adolescents with spastic cerebral palsy robust trial a parallel group randomized controlled trial |
| topic | cerebral palsy strengthening exercises physiotherapy trial resistance exercises randomized controlled trial physiotherapists physiotherapy exercise programme clinicians muscle strength gross motor function classification system spastic cerebral palsy |
| url | https://online.boneandjoint.org.uk/doi/epdf/10.1302/2633-1462.65.BJO-2024-0268 |
| work_keys_str_mv | AT sallyhopewell clinicaleffectivenessofanindividuallytailoredstrengtheningprogrammeincludingprogressiveresistanceexercisesandadvicecomparedtousualcareforambulantadolescentswithspasticcerebralpalsyrobusttrialaparallelgrouprandomizedcontrolledtrial AT davidjkeene clinicaleffectivenessofanindividuallytailoredstrengtheningprogrammeincludingprogressiveresistanceexercisesandadvicecomparedtousualcareforambulantadolescentswithspasticcerebralpalsyrobusttrialaparallelgrouprandomizedcontrolledtrial AT ioanamarian clinicaleffectivenessofanindividuallytailoredstrengtheningprogrammeincludingprogressiveresistanceexercisesandadvicecomparedtousualcareforambulantadolescentswithspasticcerebralpalsyrobusttrialaparallelgrouprandomizedcontrolledtrial AT danielcperry clinicaleffectivenessofanindividuallytailoredstrengtheningprogrammeincludingprogressiveresistanceexercisesandadvicecomparedtousualcareforambulantadolescentswithspasticcerebralpalsyrobusttrialaparallelgrouprandomizedcontrolledtrial AT inesrombach clinicaleffectivenessofanindividuallytailoredstrengtheningprogrammeincludingprogressiveresistanceexercisesandadvicecomparedtousualcareforambulantadolescentswithspasticcerebralpalsyrobusttrialaparallelgrouprandomizedcontrolledtrial AT moragandrew clinicaleffectivenessofanindividuallytailoredstrengtheningprogrammeincludingprogressiveresistanceexercisesandadvicecomparedtousualcareforambulantadolescentswithspasticcerebralpalsyrobusttrialaparallelgrouprandomizedcontrolledtrial AT catherinebarry clinicaleffectivenessofanindividuallytailoredstrengtheningprogrammeincludingprogressiveresistanceexercisesandadvicecomparedtousualcareforambulantadolescentswithspasticcerebralpalsyrobusttrialaparallelgrouprandomizedcontrolledtrial AT lorettadavis clinicaleffectivenessofanindividuallytailoredstrengtheningprogrammeincludingprogressiveresistanceexercisesandadvicecomparedtousualcareforambulantadolescentswithspasticcerebralpalsyrobusttrialaparallelgrouprandomizedcontrolledtrial AT gregoryfirth clinicaleffectivenessofanindividuallytailoredstrengtheningprogrammeincludingprogressiveresistanceexercisesandadvicecomparedtousualcareforambulantadolescentswithspasticcerebralpalsyrobusttrialaparallelgrouprandomizedcontrolledtrial AT heidifletcher clinicaleffectivenessofanindividuallytailoredstrengtheningprogrammeincludingprogressiveresistanceexercisesandadvicecomparedtousualcareforambulantadolescentswithspasticcerebralpalsyrobusttrialaparallelgrouprandomizedcontrolledtrial AT bethfordham clinicaleffectivenessofanindividuallytailoredstrengtheningprogrammeincludingprogressiveresistanceexercisesandadvicecomparedtousualcareforambulantadolescentswithspasticcerebralpalsyrobusttrialaparallelgrouprandomizedcontrolledtrial AT vivigregoryosborne clinicaleffectivenessofanindividuallytailoredstrengtheningprogrammeincludingprogressiveresistanceexercisesandadvicecomparedtousualcareforambulantadolescentswithspasticcerebralpalsyrobusttrialaparallelgrouprandomizedcontrolledtrial AT helengregoryosborne clinicaleffectivenessofanindividuallytailoredstrengtheningprogrammeincludingprogressiveresistanceexercisesandadvicecomparedtousualcareforambulantadolescentswithspasticcerebralpalsyrobusttrialaparallelgrouprandomizedcontrolledtrial AT lesleykatchburian clinicaleffectivenessofanindividuallytailoredstrengtheningprogrammeincludingprogressiveresistanceexercisesandadvicecomparedtousualcareforambulantadolescentswithspasticcerebralpalsyrobusttrialaparallelgrouprandomizedcontrolledtrial AT joannaomahoney clinicaleffectivenessofanindividuallytailoredstrengtheningprogrammeincludingprogressiveresistanceexercisesandadvicecomparedtousualcareforambulantadolescentswithspasticcerebralpalsyrobusttrialaparallelgrouprandomizedcontrolledtrial AT jeremyparr clinicaleffectivenessofanindividuallytailoredstrengtheningprogrammeincludingprogressiveresistanceexercisesandadvicecomparedtousualcareforambulantadolescentswithspasticcerebralpalsyrobusttrialaparallelgrouprandomizedcontrolledtrial AT rachelrapson clinicaleffectivenessofanindividuallytailoredstrengtheningprogrammeincludingprogressiveresistanceexercisesandadvicecomparedtousualcareforambulantadolescentswithspasticcerebralpalsyrobusttrialaparallelgrouprandomizedcontrolledtrial AT jenniferryan clinicaleffectivenessofanindividuallytailoredstrengtheningprogrammeincludingprogressiveresistanceexercisesandadvicecomparedtousualcareforambulantadolescentswithspasticcerebralpalsyrobusttrialaparallelgrouprandomizedcontrolledtrial AT elnazsaeedi clinicaleffectivenessofanindividuallytailoredstrengtheningprogrammeincludingprogressiveresistanceexercisesandadvicecomparedtousualcareforambulantadolescentswithspasticcerebralpalsyrobusttrialaparallelgrouprandomizedcontrolledtrial AT meganstone clinicaleffectivenessofanindividuallytailoredstrengtheningprogrammeincludingprogressiveresistanceexercisesandadvicecomparedtousualcareforambulantadolescentswithspasticcerebralpalsyrobusttrialaparallelgrouprandomizedcontrolledtrial AT helenwood clinicaleffectivenessofanindividuallytailoredstrengtheningprogrammeincludingprogressiveresistanceexercisesandadvicecomparedtousualcareforambulantadolescentswithspasticcerebralpalsyrobusttrialaparallelgrouprandomizedcontrolledtrial AT timtheologis clinicaleffectivenessofanindividuallytailoredstrengtheningprogrammeincludingprogressiveresistanceexercisesandadvicecomparedtousualcareforambulantadolescentswithspasticcerebralpalsyrobusttrialaparallelgrouprandomizedcontrolledtrial |