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

Cerebral Palsy Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00419432
• Other study ID #: 1000009387
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2007
• Est. completion date: December 2023

Study information

• Verified date: February 2021
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2023
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

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.
• 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

Locations

Country	Name	City	State
Canada	Glenrose Rehabilitation Hospital	Edmonton	Alberta
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	British Columbia's Children's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Activity Scale for Kids (ASK)	A reliable and valid, self-report measure of childhood physical disability.	Baseline, 6, 12, 24 months follow up
Secondary	Gillette Gait (Normalcy) Index (GGI)	Quantifies the magnitude of gait deviation from normal	Baseline, 6, 12, 24 months follow up
Secondary	Gait Parameters	Gait velocity; Stride length; O2 consumption & O2 Cost during walking	Baseline, 12-, 24-months follow-up