Does the use of gait analysis for decision making, improve outcomes of surgery for children with cerebral palsy?
| ISRCTN | ISRCTN51084195 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51084195 |
| ClinicalTrials.gov number | NCT00419432 |
| Secondary identifying numbers | MCT-99826 |
- Submission date
- 25/02/2010
- Registration date
- 08/03/2010
- Last edited
- 11/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Unni G. Narayanan
Scientific
Scientific
Division of Orthopaedic Surgery
The Hospital for Sick Children
555 University Avenue, S-107
Toronto
M5G 1X8
Canada
Study information
| Study design | Multicentre patient and outcomes-assessor blinded pilot randomised controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Functional outcomes following orthopaedic surgery based on gait laboratory versus observational gait analysis in ambulatory children with cerebral palsy: a multicentre pilot randomised controlled trial |
| Study objectives | For ambulatory children with cerebral palsy (CP) who undergo multi-level lower extremity orthopaedic surgery, the addition of gait analysis for surgical decision-making compared with observational analysis alone, results in greater improvement in function and/or gait appearance 2 years after surgery. Specific objectives of the pilot trial: The goal of this pilot trial is to establish the feasibility of, and to provide the template for the design and implementation of the definitive large multicentre trial to answer the question above. The specific objectives include: 1. Establish the feasibility of implementing the randomised trial study design in multiple centres 2. Estimate recruitment rates and timelines 3. Establish responsiveness of outcome measures to finalise the primary and secondary outcomes 4. Estimate effect sizes of functional outcomes for sample size calculations 5. Establish data management system (web-based database) for definitive multicentre study 6. Assess feasibility, reliability and face validity of pilot health economic data forms to include health economic evaluation in the future definitive multicentre 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- and inter-rater reliability |
| Ethics approval(s) | 1. Canada: Research Ethics Board (REB) of The Hospital for Sick Children approved in October 2006 (ref: 1000009387); reviewed and approved annually 2. Canada: REB of Bloorview Kids Rehab approved in February 2007 (ref: 06-013); reviewed and approved annually Approval pending from: 3. Canada: REB of British Columbia Children's Hospital 4. Canada: REB of Glenrose Rehabilitation Hospital 5. USA: Institutional Review Board (IRB) of the University of Wisconsin All other centres will seek ethics approval before recruiting participants. |
| Health condition(s) or problem(s) studied | Cerebral palsy |
| Intervention | Children allocated to Group A (controls) will undergo orthopaedic surgery based on the physical examination and observational analysis of the gait alone, while children allocated to Group B (experimental) will undergo orthopaedic surgery using the physical examination, observational and the gait laboratory analysis data. Treatment in this case is an assessment (gait, PT and questionnaires lasting approximately 4 hours) at baseline, 6, 12 and 24 months follow-up. The exact same procedures apply to each arm of the study (it is the information from the gait assessment that may or may not be given to the surgeon depending on randomisation), therefore any child on the study can expect to participate for 24 months. |
| Intervention type | Other |
| Primary outcome measure | 1. Gross Motor Function Measure (GMFM-66) 2. Gillette Gait (Normalcy) Index (GGI) 3. Pediatric Outcomes Data Collection Instrument (PODCI) 4. Functional Assessment Questionnaire (FAQ) 5. Functional Mobility Scale (FMS) 6. Activities Scale for Kids (ASK-performance) 7. Gait Parameters: gait velocity and stride length The final primary and secondary outcome measures will be chosen based on responsiveness and their effect sizes used to calculate sample size for the definitive trial |
| Secondary outcome measures | Consistency of Surgeons' Decision Making: intra- and inter-rater reliability The final primary and secondary outcome measures will be chosen based on responsiveness and their effect sizes used to calculate sample size for the definitive trial |
| Overall study start date | 01/03/2010 |
| Completion date | 01/08/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 15 Years |
| Sex | Both |
| Target number of participants | 50 |
| Key inclusion criteria | 1. Diagnosis of spastic cerebral palsy 2. Age 6 to 15 years at the time of the initial assessment, either sex 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 and ankle) 7. Patients must be able to undergo instrumented gait analysis testing in a motion laboratory |
| Key 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 |
| Date of first enrolment | 01/03/2010 |
| Date of final enrolment | 01/08/2013 |
Locations
Countries of recruitment
- Canada
- United States of America
Study participating centre
Division of Orthopaedic Surgery
Toronto
M5G 1X8
Canada
M5G 1X8
Canada
Sponsor information
Bloorview Kids Rehab (Canada)
Hospital/treatment centre
Hospital/treatment centre
150 Kilgour Road
Toronto
M4G 1R8
Canada
| Website | http://www.bloorview.ca |
|---|---|
"ROR" |
https://ror.org/03qea8398 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-99826)
No information available
Bloorview Children's Hospital Foundation (Canada)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
11/04/2019: No publications found, verifying study status with principal investigator.
