Outcomes of Orthopaedic Surgery Using Gait Laboratory Versus Observational Gait Analysis in Children With Cerebral Palsy

Functional Outcomes Following Orthopaedic Surgery Based on Gait Laboratory Versus Observational Gait Analysis in Ambulatory Children With Cerebral Palsy: A Multi-center Randomized Controlled Trial.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: Routine Observational Analysis (prior to procedure); Other: Routine Observational analysis supplemented with Gait Lab Information (prior to procedure)

Detailed Description

Children with cerebral palsy, who are ambulatory, have an inefficient gait often associated with functional disability. Many of these children are candidates for orthopaedic surgery, which includes multi-level soft tissue and bony procedures. Pre-operative planning is based on the physical examination and visual (observational) analysis of the child's gait. In some centres, patients undergo additional gait analysis in a motion laboratory. While gait laboratory analysis is accepted as an important research tool, there is controversy about its clinical utility in decision making for the surgical management of this population. To date, no clinical trials have been undertaken to answer this question, and the appropriate clinical utilization of this technology is yet to be established. The consequence of this uncertainty is that ambulatory children with cerebral palsy are either being deprived of a useful assessment tool in some centres, or alternatively they are being subjected to an unnecessary evaluation that is both expensive and time consuming in other centres. A multi-centre randomized trial will provide evidence to support or refute the need for gait laboratory analysis for surgical decision-making for this population. This pilot randomized controlled trial in four sites will assess the feasibility of, and provide the template for the design and conduct of the definitive larger multi-centred trial to extend its generalizability across North America and other jurisdictions. The specific objectives include:

1. Establish the feasibility of implementing the randomized trial study design in multiple centres
2. Estimate recruitment rates and timelines
3. Establish responsiveness of outcome measures to finalize the primary & secondary outcomes
4. Estimate effect sizes of functional outcomes for sample size calculations
5. Establish data management system (web-based database) for definitive multi-centre study.

6. Assess feasibility, reliability and face validity of pilot health economic data forms to include health economic evaluation in the future definitive multi-centre trial.

   Secondary objectives include:

7. Does the addition of gait analysis alter surgical decisions made from video observation alone, when performed in the setting of this pilot trial?
8. Evaluate the consistency of the surgical decision making: intra- & inter rater reliability

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada
      • Glenrose Rehabilitation Hospital
  • British Columbia
    • Vancouver, British Columbia, Canada
      • British Columbia's Children's Hospital
  • Ontario
    • Mississauga, Ontario, Canada, L5L 2M5
      • Erinoak Centre
    • Oshawa, Ontario, Canada, L1H 7K6
      • Grandview Children's Rehabilitation Centre
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children
    • Toronto, Ontario, Canada, M4G 1R8
      • Bloorview Kids Rehab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Diagnosis of spastic cerebral palsy.
2. Age 6 to 15 years at the time of the initial assessment.
3. Gross Motor Function Classification System (GMFCS) levels II or III (demonstrable independent ambulatory potential with or without orthotics/assist devices).
4. Patients have been referred for assessment and treatment of gait abnormality.
5. Patients have a gait abnormality interfering with their physical function.
6. 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).
7. Patients must be able to undergo instrumented gait analysis in a motion laboratory.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A (standard pre-operative analysis)	Other: Routine Observational Analysis (prior to procedure); Controls will undergo the standard orthopaedic surgery using the information from the physical examination and observational analysis of the gait alone.
Experimental: Group B (additional pre-operative analysis)	Other: Routine Observational analysis supplemented with Gait Lab Information (prior to procedure); This experimental group will undergo standard orthopaedic surgery using the information from the physical examination, observational AND the gait laboratory analysis data

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gross Motor Function Measure (GMFM-66)	A well validated condition specific clinical measure to evaluate change in motor function in children with cerebral palsy	Baseline, 6, 12, 24 months follow up
Pediatric Outcomes Data Collection Instrument(PODCI)	A generic measure of musculoskeletal functional health outcomes in children and adolescents	Baseline, 6, 12, 24 months follow up
Gillette Functional Assessment Questionnaire (FAQ)	A validated condition specific functional walking scale developed for children with cerebral palsy	Baseline, 6, 12, 24 months follow up
Functional Mobility Scale (FMS)	Developed to measure functional mobility of a child in three different environments (home, school, and the wider community).	Baseline, 6, 12, 24 months follow up
Activity Scale for Kids (ASK)	A reliable and valid, self-report measure of childhood physical disability.	Baseline, 6, 12, 24 months follow up
Gillette Gait (Normalcy) Index (GGI)	Quantifies the magnitude of gait deviation from normal	Baseline, 6, 12, 24 months follow up
Gait Parameters	Gait velocity; Stride length; O2 consumption & O2 Cost during walking	Baseline, 12-, 24-months follow-up

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Investigators: Principal Investigator: Unni Narayanan, MBBS, MSc, FRCSC, The Hospital for Sick Children, Toronto Canada

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): August 1, 2019
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: January 5, 2007
• First Submitted That Met QC Criteria: January 5, 2007
• First Posted (Estimate): January 8, 2007

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 9, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Cerebral Palsy; Pediatrics; Gait Analysis; Orthopedic Surgery
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: 1000009387