Cerebral Palsy Hip Outcomes Project - International Multi-centre Study
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|ClinicalTrials.gov Identifier: NCT01987882|
Recruitment Status : Recruiting
First Posted : November 19, 2013
Last Update Posted : December 6, 2018
|Condition or disease|
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Background: Children with severe cerebral palsy (CP) are at high risk for dislocating their hips. These hips are associated with contractures and pain, which can interfere with care-giving, seating, positioning, mobility and quality of life. The primary purpose of this project (Aim 2) is to evaluate the effectiveness of different intervention strategies to prevent or relieve the symptoms associated with hip instability in children with severe non-ambulatory CP, using the validated Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD©) questionnaire as the primary outcome measure of health related quality of life (HRQL) for this population. Secondarily, this project will also measure the impact of hip displacement on HRQL of these children. This project will be the first of its kind and this scale, which will systematically study the impact of hip instability and its management in children with severe CP, using a meaningful outcome measure that was developed specifically for this purpose. The international network of investigators/sites and the infrastructure established for this project will facilitate the long term follow-up of the participants in this study, as well as the conduct of other multi-centre clinical trials and cohort studies to evaluate the effectiveness of current and future interventions aimed at improving the quality of life of children with severe disabilities.
Study Design & Participants: International multi-centre prospective longitudinal cohort study of children with severe (non-ambulant) cerebral palsy (GMFCS levels IV & V) from ages 3 to 18 who have radiographic evidence of hip displacement [Reimer's Migration Percentage (MP) ≥ 30%].
Measures: Detailed demographic information, and prognostic factors, including co-morbid conditions will be recorded at baseline, in addition to self-administered parental reports of HRQL as measured by the CPCHILD. Hip status will be classified using standardized radiographic measures of Reimer's MP and acetabular index (AI). The primary outcome measure CPCHILD, as well as the MP & AI will be measured at 6, 12 and 24 months following initial intervention.
Aim 1: Measure the impact of increasing hip displacement in children with severe (non-ambulant) CP on their HRQL as measured by the CPCHILD questionnaire.
Aim 2: (Primary Purpose): Measure the effectiveness of different strategies of interventions for hip displacement in children with severe (non-ambulant) CP in a prospective longitudinal comparative cohort study using the CPCHILD as the primary outcome measure of HRQL.
Aim 3: Compare the types and rates of adverse events and complications associated with each of the treatment cohorts.
Methods: Observational study of usual (site/surgeon specific) clinical practice. Investigators at each site will enroll eligible participants and assign each to one of the following 5 cohorts based on individual treating doctor's &/or parental preferences:
A. "Natural" history or watchful waiting (N=100)
B. Serial botulinum toxin injections +/- abduction bracing (N=100)
C. Adductor (+/- psoas) muscle releases alone (N=100)
D. Hip reconstructive surgery (N=100)
E. Salvage hip surgery (N=100)
The baseline MP and CPCHILD scores for all participants will be analyzed cross-sectionally to evaluate the correlation between hip displacement and the CPCHILD scores to serve Aim 1. For Aim 2, children undergoing interventions for hip instability (Groups B, C, D, & E) will be compared with each other as well as with their respective matched counterparts of untreated children (Group A), using repeated measures of analysis of covariance (ANOCOVA) to measure the mean change in scores from baseline at 6, 12 and 24 months after intervention.
Timelines: 500 participants will be recruited in 24 months, and followed for 24 months. The analysis, reporting of results, manuscript development and knowledge transfer will take 12 months. In total, the study will take 5 years to complete.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||500 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||Outcomes of Hip Interventions for Children With Cerebral Palsy - An International Multi-centre Prospective Comparative Cohort Study|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
|A. "Natural" History or Watchful Waiting|
|B. Serial Botulinum Toxin Injections +/- Abduction Bracing|
|C. Adductor (+/- psoas) Muscle Releases Alone|
|D. Hip Reconstructive Surgery|
|E. Salvage Hip Surgery|
- CPCHILD questionnaire: Total Score (0-100) [ Time Frame: Change from baseline to 12 months after treatment ]The primary outcome measure will be based at the 12 month assessment. The CPCHILD questionnaire is a validated outcome measure of health-related quality of life specifically developed for children with severe, non-ambulant cerebral palsy (GMFCS level IV and V) to evaluate the effectiveness of different treatment options.
- CPCHILD Questionnaire: Total Score (0-100) [ Time Frame: Change from baseline to 24 months after treatment ]The CPCHILD questionnaire is a validated outcome measure of health-related quality of life specifically developed for children with severe, non-ambulant cerebral palsy (GMFCS level IV and V) to evaluate the effectiveness of different treatment options.
- Reimer's Migration Percentage (MP) [ Time Frame: Change from baseline to 24 months after treatment ]The Reimer's Migration Percentage (MP) quantifies the magnitude of the displacement of the femoral head that is uncovered by the acetabulum.
- Acetabular Index (AI) in degrees [ Time Frame: Change from baseline to 24 months after treatment ]The Acetabular Index (AI) in degrees quantifies the magnitude of acetabular dysplasia.
- Morphological Hip Classification in Cerebral Palsy (MHC) [ Time Frame: Change from baseline to 24 months after treatment ]The Morphological Hip Classification in Cerebral Palsy (MHC) describes the sphericity of the femoral head.
- CPCHILD Questionnaire: Subscale Scores (0 - 100) [ Time Frame: Change from baseline to 24 months after treatment ]
The Subscale scores of the CPCHILD© questionnaire represent the following domains:
- Activities of Daily Living/Personal Care (9 items);
- Positioning, Transferring & Mobility (8);
- Comfort & Emotions (9);
- Communication & Social Interaction (7);
- Health (3);
- Overall Quality of Life (1).
Standardized scores are generated on a scale of 0 (worst) to 100 (best) for each of the 6 domains.
- Adverse Events and Complications [ Time Frame: Adverse events will be recorded up to 24 months after treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01987882
|Contact: Dr. Unni Narayanan, MBBS, MSc, FRCSCemail@example.com|
|Contact: Ashley Ferkul, BAfirstname.lastname@example.org|
Show 27 Study Locations
|Principal Investigator:||Dr. Unni Narayanan, MBBS, MSc, FRCSC||Holland Bloorview Kids Rehab and The Hospital for Sick Children, Toronto, Canada|