NCT00419432

Brief Summary

The purpose of this pilot trial is to determine whether the addition of gait laboratory analysis for surgical decision making, compared with the use of observational analysis alone, results in improved functional outcomes in ambulatory children with cerebral palsy undergoing multi-level lower extremity orthopaedic surgery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 8, 2007

Completed
12.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

12.6 years

First QC Date

January 5, 2007

Last Update Submit

February 9, 2021

Conditions

Cerebral Palsy

Keywords

PediatricsCerebral PalsyGait AnalysisOrthopedic Surgery

Outcome Measures

Primary Outcomes (1)

  • General Effect Size of Secondary Outcomes

    The final primary and secondary outcome measures will be chosen based on responsiveness and their effect sizes used to calculate sample size for a future definitive trial.

    Post Study

Secondary Outcomes (7)

  • Gross Motor Function Measure (GMFM-66)

    Baseline, 6, 12, 24 months follow up

  • Pediatric Outcomes Data Collection Instrument(PODCI)

    Baseline, 6, 12, 24 months follow up

  • Gillette Functional Assessment Questionnaire (FAQ)

    Baseline, 6, 12, 24 months follow up

  • Functional Mobility Scale (FMS)

    Baseline, 6, 12, 24 months follow up

  • Activity Scale for Kids (ASK)

    Baseline, 6, 12, 24 months follow up

  • +2 more secondary outcomes

Study Arms (2)

Group A (standard pre-operative analysis)

ACTIVE COMPARATOR
Other: Routine Observational Analysis (prior to procedure)

Group B (additional pre-operative analysis)

EXPERIMENTAL
Other: Routine Observational analysis supplemented with Gait Lab Information (prior to procedure)

Interventions

Routine Observational Analysis (prior to procedure)OTHER

Controls will undergo the standard orthopaedic surgery using the information from the physical examination and observational analysis of the gait alone.

Group A (standard pre-operative analysis)
Routine Observational analysis supplemented with Gait Lab Information (prior to procedure)OTHER

This experimental group will undergo standard orthopaedic surgery using the information from the physical examination, observational AND the gait laboratory analysis data

Group B (additional pre-operative analysis)

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of spastic cerebral palsy.
  • Age 6 to 15 years at the time of the initial assessment.
  • Gross Motor Function Classification System (GMFCS) levels II or III (demonstrable independent ambulatory potential with or without orthotics/assist devices).
  • Patients have been referred for assessment and treatment of gait abnormality.
  • Patients have a gait abnormality interfering with their physical function.
  • Patients are candidates for orthopaedic surgery including soft tissue and/or bony procedures involving at least 2 levels, in one or both lower extremities (e.g. knee \& ankle).
  • Patients must be able to undergo instrumented gait analysis in a motion laboratory.

You may not qualify if:

  • Presence of dystonia, athetosis, or mixed tone abnormalities.
  • History of orthopaedic lower extremity procedures within the previous 2 years.
  • Patients who have had previous gait laboratory analysis that has been seen by the treating surgeon.
  • Patients who will be unable to return for the required follow up visits/gait analysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Glenrose Rehabilitation Hospital

Edmonton, Alberta, Canada

Location

British Columbia's Children's Hospital

Vancouver, British Columbia, Canada

Location

Erinoak Centre

Mississauga, Ontario, L5L 2M5, Canada

Location

Grandview Children's Rehabilitation Centre

Oshawa, Ontario, L1H 7K6, Canada

Location

Bloorview Kids Rehab

Toronto, Ontario, M4G 1R8, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Unni Narayanan, MBBS, MSc, FRCSC

    The Hospital for Sick Children, Toronto Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopaedic Surgeon

Study Record Dates

First Submitted

January 5, 2007

First Posted

January 8, 2007

Study Start

January 1, 2007

Primary Completion

August 1, 2019

Study Completion

December 1, 2023

Last Updated

February 10, 2021

Record last verified: 2021-02

Locations

CA(6)