Recruiting

Observational Study

Sponsor:

Holland Bloorview Kids Rehabilitation Hospital

Code:

NCT01987882

Conditions

Cerebral Palsy

Eligibility Criteria

Sex: All

Age: 2 - 18

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT01987882

Start date

Jun, 2014

Status verified date

Feb, 2021

Completion date

Apr, 2022

Anticipated

Primary completion date

Apr, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 18

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

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 measure

  • CPCHILD questionnaire: Total Score (0-100) [ Time Frame: Change from baseline to 12 months after treatment ]

Central Contacts and Locations

Central contacts

Dr. Unni Narayanan, MBBS, MSc, FRCSC

unni.narayanan@sickkids.ca

Ashley Ferkul, BA

ashley.ferkul@sickkids.ca

Locations

Shriners Hospitals for Children - Northern California

Recruiting

Sacramento, California, United States

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States

Alfred I. Dupont Institute

Recruiting

Wilmington, Delaware, United States

Children's Hospital Boston

Recruiting

Boston, Massachusetts, United States

Gillette Children's Specialty Healthcare

Recruiting

Saint Paul, Minnesota, United States

Children's of Mississippi

Recruiting

Jackson, Mississippi, United States

Hospital for Special Surgery

Recruiting

New York, New York, United States

New York-Presbyterian Morgan Stanley Children's Hospital

Recruiting

New York, New York, United States

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States

BC Children's Hospital

Recruiting

Vancouver, British Columbia, Canada

Holland Bloorview Kids Rehabilitation Hospital

Recruiting

Toronto, Ontario, Canada

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada

Shriners Hospital for Children - Canada

Recruiting

Montreal, Quebec, Canada

More Information

Sponsor

Holland Bloorview Kids Rehabilitation Hospital

Last update posted

Feb 11, 2021

Last verified

Feb, 2021

Keywords

  • Outcomes research, treatment effectiveness, quality of life

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Holland Bloorview Kids Rehabilitation Hospital on 2021-02-11.