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

NCT ID: NCT00419432

Last Updated: 2021-02-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2023-12-31

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.

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

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group A (standard pre-operative analysis)

Group Type: ACTIVE_COMPARATOR

Routine Observational Analysis (prior to procedure)

Intervention Type: OTHER

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

Group B (additional pre-operative analysis)

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Unni Narayanan

Orthopaedic Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Unni Narayanan, MBBS, MSc, FRCSC

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children, Toronto Canada

Locations

Glenrose Rehabilitation Hospital

Edmonton, Alberta, Canada

British Columbia's Children's Hospital

Vancouver, British Columbia, Canada

Erinoak Centre

Mississauga, Ontario, Canada

Grandview Children's Rehabilitation Centre

Oshawa, Ontario, Canada

Bloorview Kids Rehab

Toronto, Ontario, Canada

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

1000009387

Identifier Type: -

Identifier Source: org_study_id