Gastrocsoleus Lengthening in Cerebral Palsy
Range of Ankle and Knee Motion Development After Gastrocsoleus Lengthening in Cerebral Palsy: a Register-based Prospective Cohort Study: Registered Report Protocol
1 other identifier
observational
186
0 countries
N/A
Brief Summary
The goal of this study is to compare passive ankle and knee range of motion (ROM) development after surgery to the gastrocsoleus complex, in children with cerebral palsy (CP). The analysis will compare knee and ankle ROM development between types and levels of surgery performed to achieve lengthening of the gastrosoleus complex. Also, associations between treatment outcomes and Gross Motor Classification System level (GMFCS-level) as well as CP-subtype will be evaluated. This is a retrospective longitudinal study on the effects of gastrocsoleus complex lengthening on ROM development. The study is based on data from the Swedish Surveillance Program for Cerebral Palsy (CPUP)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2000
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 13, 2023
CompletedFirst Posted
Study publicly available on registry
March 24, 2023
CompletedMarch 24, 2023
March 1, 2023
13.9 years
March 13, 2023
March 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ankle ROM
Polynomial regression coefficients describing mean ankle ROM development over follow-up time.
Subjects will be followed from date of primary surgery to failure, the last assessment or end of study, at year 2022
Secondary Outcomes (3)
Knee ROM
Subjects will be followed from date of primary surgery to failure, the last assessment or end of study, at year 2022
Composite endpoint
Subjects will be followed from date of primary surgery to failure, the last assessment or end of study, at year 2022
Each component endpoint
Subjects will be followed from date of primary surgery to failure, the last assessment or end of study, at year 2022
Study Arms (3)
Tendo Achilles Lengthening (TAL), percutaneous
Percutaneous lengthening of the achilles tendon.
Tendo Achilles Lengthening (TAL), open
Open surgery with lengthening of the achilles tendon.
Gastrocsoleus lengthening in zone 1 and 2
Lengthening of the gasrocnemius or its aponeurosis.
Eligibility Criteria
Children registered in CPUP Sweden (Follow up surveillance program for people with verebral palsy), treated with isolated surgical lengthening of the gastrocsoleus complex and born 2000-2011.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Skanelead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 7 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Paediatric Orthopaedic Surgeon
Study Record Dates
First Submitted
March 13, 2023
First Posted
March 24, 2023
Study Start
January 1, 2000
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
March 24, 2023
Record last verified: 2023-03