GRIN: " GRoup versus INdividual physiotherapy following lower limb intra-muscular Botulinum Toxin-A injections for ambulant children with cerebral palsy: An assessor-masked randomised comparison trial": Study protocol
Background: Cerebral palsy is the most common cause of physical disability in childhood. Spasticity is a significant contributor to the secondary impairments impacting functional performance and participation. The most common lower limb spasticity management is focal intramuscular injections of Botu...
| Main Authors: | , , , , |
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| Format: | Journal Article |
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2014
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| Online Access: | http://hdl.handle.net/20.500.11937/16826 |
| _version_ | 1848749288197193728 |
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| author | Thomas, R. Johnston, L. Boyd, Roslyn Sakzewski, L. Kentish, M. |
| author_facet | Thomas, R. Johnston, L. Boyd, Roslyn Sakzewski, L. Kentish, M. |
| author_sort | Thomas, R. |
| building | Curtin Institutional Repository |
| collection | Online Access |
| description | Background: Cerebral palsy is the most common cause of physical disability in childhood. Spasticity is a significant contributor to the secondary impairments impacting functional performance and participation. The most common lower limb spasticity management is focal intramuscular injections of Botulinum Toxin-Type A accompanied by individually-delivered (one on one) physiotherapy rehabilitation. With increasing emphasis on improving goal-directed functional activity and participation within a family-centred framework, it is timely to explore whether physiotherapy provided in a group could achieve comparable outcomes, encouraging providers to offer flexible models of physiotherapy delivery. This study aims to compare individual to group-based physiotherapy following intramuscular Botulinum Toxin-A injections to the lower limbs for ambulant children with cerebral palsy aged four to fourteen years.Methods/Design: An assessor-masked, block randomised comparison trial will be conducted with random allocation to either group-based or individual physiotherapy. A sample size of 30 (15 in each study arm) will be recruited. Both groups will receive six hours of direct therapy following Botulinum Toxin-A injections in either an individual or group format with additional home programme activities (three exercises to be performed three times a week). Study groups will be compared at baseline (T1), then at 10 weeks (T2, efficacy) and 26 weeks (T3, retention) post Botulinum Toxin-A injections. Primary outcomes will be caregiver/s perception of and satisfaction with their child's occupational performance goals (Canadian Occupational Performance Measure) and quality of gait (Edinburgh Visual Gait Score) with a range of secondary outcomes across domains of the International Classification of Disability, Functioning and Health.Discussion: This paper outlines the study protocol including theoretical basis, study hypotheses and outcome measures for this assessor-masked, randomised comparison trial comparing group versus individual models of physiotherapy following intramuscular injections of Botulinum Toxin-A to the lower limbs for ambulant children with cerebral palsy.Trial registration: ACTRN12611000454976. © 2014 Thomas et al.; licensee BioMed Central Ltd. |
| first_indexed | 2025-11-14T07:18:33Z |
| format | Journal Article |
| id | curtin-20.500.11937-16826 |
| institution | Curtin University Malaysia |
| institution_category | Local University |
| last_indexed | 2025-11-14T07:18:33Z |
| publishDate | 2014 |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | curtin-20.500.11937-168262017-09-13T15:42:22Z GRIN: " GRoup versus INdividual physiotherapy following lower limb intra-muscular Botulinum Toxin-A injections for ambulant children with cerebral palsy: An assessor-masked randomised comparison trial": Study protocol Thomas, R. Johnston, L. Boyd, Roslyn Sakzewski, L. Kentish, M. Background: Cerebral palsy is the most common cause of physical disability in childhood. Spasticity is a significant contributor to the secondary impairments impacting functional performance and participation. The most common lower limb spasticity management is focal intramuscular injections of Botulinum Toxin-Type A accompanied by individually-delivered (one on one) physiotherapy rehabilitation. With increasing emphasis on improving goal-directed functional activity and participation within a family-centred framework, it is timely to explore whether physiotherapy provided in a group could achieve comparable outcomes, encouraging providers to offer flexible models of physiotherapy delivery. This study aims to compare individual to group-based physiotherapy following intramuscular Botulinum Toxin-A injections to the lower limbs for ambulant children with cerebral palsy aged four to fourteen years.Methods/Design: An assessor-masked, block randomised comparison trial will be conducted with random allocation to either group-based or individual physiotherapy. A sample size of 30 (15 in each study arm) will be recruited. Both groups will receive six hours of direct therapy following Botulinum Toxin-A injections in either an individual or group format with additional home programme activities (three exercises to be performed three times a week). Study groups will be compared at baseline (T1), then at 10 weeks (T2, efficacy) and 26 weeks (T3, retention) post Botulinum Toxin-A injections. Primary outcomes will be caregiver/s perception of and satisfaction with their child's occupational performance goals (Canadian Occupational Performance Measure) and quality of gait (Edinburgh Visual Gait Score) with a range of secondary outcomes across domains of the International Classification of Disability, Functioning and Health.Discussion: This paper outlines the study protocol including theoretical basis, study hypotheses and outcome measures for this assessor-masked, randomised comparison trial comparing group versus individual models of physiotherapy following intramuscular injections of Botulinum Toxin-A to the lower limbs for ambulant children with cerebral palsy.Trial registration: ACTRN12611000454976. © 2014 Thomas et al.; licensee BioMed Central Ltd. 2014 Journal Article http://hdl.handle.net/20.500.11937/16826 10.1186/1471-2431-14-35 unknown |
| spellingShingle | Thomas, R. Johnston, L. Boyd, Roslyn Sakzewski, L. Kentish, M. GRIN: " GRoup versus INdividual physiotherapy following lower limb intra-muscular Botulinum Toxin-A injections for ambulant children with cerebral palsy: An assessor-masked randomised comparison trial": Study protocol |
| title | GRIN: " GRoup versus INdividual physiotherapy following lower limb intra-muscular Botulinum Toxin-A injections for ambulant children with cerebral palsy: An assessor-masked randomised comparison trial": Study protocol |
| title_full | GRIN: " GRoup versus INdividual physiotherapy following lower limb intra-muscular Botulinum Toxin-A injections for ambulant children with cerebral palsy: An assessor-masked randomised comparison trial": Study protocol |
| title_fullStr | GRIN: " GRoup versus INdividual physiotherapy following lower limb intra-muscular Botulinum Toxin-A injections for ambulant children with cerebral palsy: An assessor-masked randomised comparison trial": Study protocol |
| title_full_unstemmed | GRIN: " GRoup versus INdividual physiotherapy following lower limb intra-muscular Botulinum Toxin-A injections for ambulant children with cerebral palsy: An assessor-masked randomised comparison trial": Study protocol |
| title_short | GRIN: " GRoup versus INdividual physiotherapy following lower limb intra-muscular Botulinum Toxin-A injections for ambulant children with cerebral palsy: An assessor-masked randomised comparison trial": Study protocol |
| title_sort | grin: " group versus individual physiotherapy following lower limb intra-muscular botulinum toxin-a injections for ambulant children with cerebral palsy: an assessor-masked randomised comparison trial": study protocol |
| url | http://hdl.handle.net/20.500.11937/16826 |