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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
Sponsor:
Collaborator:
The Hospital for Sick Children
Information provided by (Responsible Party):
Holland Bloorview Kids Rehabilitation Hospital

Brief Summary:
The primary purpose of the project is to evaluate the effectiveness of different intervention strategies to prevent or relieve symptoms associated with hip instability in children with severe cerebral palsy, 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 for this population.

Condition or disease
Cerebral Palsy

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Detailed Description:

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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:

    1. Activities of Daily Living/Personal Care (9 items);
    2. Positioning, Transferring & Mobility (8);
    3. Comfort & Emotions (9);
    4. Communication & Social Interaction (7);
    5. Health (3);
    6. Overall Quality of Life (1).

    Standardized scores are generated on a scale of 0 (worst) to 100 (best) for each of the 6 domains.



Other Outcome Measures:
  1. Adverse Events and Complications [ Time Frame: Adverse events will be recorded up to 24 months after treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children with severe, non-ambulant cerebral palsy (GMFCS level IV and V) and their parent / primary caregiver will be enrolled in the study.
Criteria

Inclusion Criteria:

  • Children with a working diagnosis of cerebral palsy or cerebral palsy-like condition
  • Between 2 to 18 years of age
  • Has a migration percentage ≥ 30%
  • Non-ambulatory; the primary mode of mobility is a wheelchair
  • Parent/primary caregiver must understand one of the languages in which the CPCHILD has been translated, culturally adapted and validated.

Exclusion Criteria:

  • History of prior hip surgery
  • Received botulinum toxin injection within the previous 3 months. Recruitment will be delayed until at least 3 months after prior botulinum toxin injection.

Information from the National Library of Medicine

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


Contacts
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Contact: Dr. Unni Narayanan, MBBS, MSc, FRCSC unni.narayanan@sickkids.ca
Contact: Ashley Ferkul, BA ashley.ferkul@sickkids.ca

  Show 27 Study Locations
Sponsors and Collaborators
Holland Bloorview Kids Rehabilitation Hospital
The Hospital for Sick Children
Investigators
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Principal Investigator: Dr. Unni Narayanan, MBBS, MSc, FRCSC Holland Bloorview Kids Rehab and The Hospital for Sick Children, Toronto, Canada

Additional Information:
Publications:
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Responsible Party: Holland Bloorview Kids Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01987882     History of Changes
Other Study ID Numbers: 313575
First Posted: November 19, 2013    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: November 2018

Keywords provided by Holland Bloorview Kids Rehabilitation Hospital:
Outcomes research, treatment effectiveness, quality of life

Additional relevant MeSH terms:
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Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases