Cerebral Palsy Hip Outcomes Project - International Multi-centre Study

NCT01987882 | Unknown

• 1 other identifier: 313575
• Study Type: observational
• Target: 500
• Locations: 10 countries
• Sites: 27

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.

Conditions

Cerebral Palsy

Keywords

Outcomes research, treatment effectiveness, quality of life

Outcome Measures

Primary Outcomes (1)

• CPCHILD questionnaire: Total Score (0-100)

  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.

  Change from baseline to 12 months after treatment

Secondary Outcomes (5)

• CPCHILD Questionnaire: Total Score (0-100)

  Change from baseline to 24 months after treatment

• Reimer's Migration Percentage (MP)

  Change from baseline to 24 months after treatment

• Acetabular Index (AI) in degrees

  Change from baseline to 24 months after treatment

• Morphological Hip Classification in Cerebral Palsy (MHC)

  Change from baseline to 24 months after treatment

• CPCHILD Questionnaire: Subscale Scores (0 - 100)

  Change from baseline to 24 months after treatment

Other Outcomes (1)

• Adverse Events and Complications

  Adverse events will be recorded up to 24 months after treatment

Study Arms (5)

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

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Holland Bloorview Kids Rehabilitation Hospital: lead
• The Hospital for Sick Children: collaborator

Study Sites (27)

Shriners Hospitals for Children - Northern California

Sacramento, California, United States

RECRUITING

Children's Hospital Colorado

Aurora, Colorado, United States

RECRUITING

Alfred I. Dupont Institute

Wilmington, Delaware, United States

RECRUITING

Children's Hospital Boston

Boston, Massachusetts, United States

RECRUITING

Gillette Children's Specialty Healthcare

Saint Paul, Minnesota, United States

RECRUITING

Children's of Mississippi

Jackson, Mississippi, United States

RECRUITING

Hospital for Special Surgery

New York, New York, United States

RECRUITING

New York-Presbyterian Morgan Stanley Children's Hospital

New York, New York, United States

RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

RECRUITING

Royal Children's Hospital

Melbourne, Victoria, Australia

RECRUITING

BC Children's Hospital

Vancouver, British Columbia, Canada

RECRUITING

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, Canada

RECRUITING

The Hospital for Sick Children

Toronto, Ontario, Canada

RECRUITING

Shriners Hospital for Children - Canada

Montreal, Quebec, Canada

RECRUITING

Aarhus University Hospital

Aarhus, Denmark

RECRUITING

Safra Hospital for Children

Tel Litwinsky, Ramat Gan, Israel

RECRUITING

Starship Children's Hospital of New Zealand

Auckland, New Zealand

RECRUITING

K. Marcinkowski Medical University

Poznan, Poland

RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

RECRUITING

Lund University Hospital

Lund, Sweden

RECRUITING

Astrid Lindgren's Children's Hospital

Stockholm, Sweden

NOT YET RECRUITING

University Hospitals Coventry & Warwickshire NHS Trust

Coventry, England, United Kingdom

RECRUITING

Alder Hey Children's NHS Foundation Trust

Liverpool, England, United Kingdom

RECRUITING

Royal National Orthopaedic Hospital

London, England, United Kingdom

RECRUITING

The Royal London and St. Bartholomew's Hospitals

London, England, United Kingdom

RECRUITING

Nuffield Orthopaedic Centre NHS Trust

Oxford, England, United Kingdom

RECRUITING

Royal Hospital for Sick Children

Edinburgh, Scotland, United Kingdom

RECRUITING

Related Publications (2)

• Narayanan UG, Fehlings D, Weir S, Knights S, Kiran S, Campbell K. Initial development and validation of the Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD). Dev Med Child Neurol. 2006 Oct;48(10):804-12. doi: 10.1017/S0012162206001745.

  PMID: 16978459 BACKGROUND

• Miller SD, Juricic M, Fajardo N, So J, Shore BJ, Narayanan UG, Mulpuri K. Variability in Postoperative Immobilization and Rehabilitation Following Reconstructive Hip Surgery in Nonambulatory Children With Cerebral Palsy. J Pediatr Orthop. 2021 Aug 1;41(7):e563-e569. doi: 10.1097/BPO.0000000000001850.

  PMID: 33999564 DERIVED

Related Links

• Website of the CPCHILD© Project

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Dr. Unni Narayanan, MBBS, MSc, FRCSC

  Holland Bloorview Kids Rehab and The Hospital for Sick Children, Toronto, Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Unni Narayanan, MBBS, MSc, FRCSC

CONTACT

unni.narayanan@sickkids.ca

Ashley Ferkul, BA

CONTACT

ashley.ferkul@sickkids.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2013
• First Posted: November 19, 2013
• Study Start: June 1, 2014
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2022
• Last Updated: February 11, 2021

Record last verified: 2021-02

Locations

IL (1); DK (1); PL (1); SE (2); GB (6); US (9); AU (1); NZ (1); CA (4); KR (1)