Cerebral PalsyNCT00419432
Outcomes of Orthopaedic Surgery Using Gait Laboratory Versus Observational Gait Analysis in Children With Cerebral Palsy
A study testing Routine Observational Analysis (prior to procedure) and Routine Observational analysis supplemented with Gait Lab Information (prior to procedure) in people with Cerebral Palsy, run by The Hospital for Sick Children at 6 sites in Canada.
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… Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Routine Observational Analysis (prior to procedure) and Routine Observational analysis supplemented with Gait Lab Information (prior to procedure)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 6 sitesCanada
- Study dates
- Jan 2007to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Glenrose Rehabilitation Hospital
Edmonton, Alberta
Erinoak Centre
Mississauga, Ontario, L5L 2M5
Grandview Children's Rehabilitation Centre
Oshawa, Ontario, L1H 7K6
Bloorview Kids Rehab
Toronto, Ontario, M4G 1R8
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
British Columbia's Children's Hospital
Vancouver, British Columbia
About this study
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.
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.
Read the 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:
- Establish the feasibility of implementing the randomized trial study design in multiple centres
- Estimate recruitment rates and timelines
- Establish responsiveness of outcome measures to finalize the primary \& secondary outcomes
- Estimate effect sizes of functional outcomes for sample size calculations
- Establish data management system (web-based database) for definitive multi-centre study.
- 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:
- Does the addition of gait analysis alter surgical decisions made from video observation alone, when performed in the setting of this pilot trial?
- Evaluate the consistency of the surgical decision making: intra- \& inter rater reliability
- Conditions
- Cerebral Palsy
- Being tested
- Routine Observational Analysis (prior to procedure), Routine Observational analysis supplemented with Gait Lab Information (prior to procedure)
- Keywords
- Pediatrics, Cerebral Palsy, Gait Analysis, Orthopedic Surgery
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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
| Study group | Role | What they receive |
|---|---|---|
| Group A (standard pre-operative analysis) | Active comparator | Not described Receives: Other: Routine Observational Analysis (prior to procedure) |
| Group B (additional pre-operative analysis) | Experimental | Not described Receives: Other: Routine Observational analysis supplemented with Gait Lab Information (prior to procedure) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post Study
Secondary outcomes (7)
Gross Motor Function Measure (GMFM-66)
A well validated condition specific clinical measure to evaluate change in motor function in children with cerebral palsy
Measured: 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
Measured: 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
Measured: 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).
Measured: Baseline, 6, 12, 24 months follow up
Activity Scale for Kids (ASK)
A reliable and valid, self-report measure of childhood physical disability.
Measured: Baseline, 6, 12, 24 months follow up
Gillette Gait (Normalcy) Index (GGI)
Quantifies the magnitude of gait deviation from normal
Measured: Baseline, 6, 12, 24 months follow up
Gait Parameters
Gait velocity; Stride length; O2 consumption \& O2 Cost during walking
Measured: Baseline, 12-, 24-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionAug 2019
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Unni Narayanan, The Hospital for Sick Children
- Investigators
- Unni Narayanan, MBBS, MSc, FRCSC, Principal investigator, The Hospital for Sick Children, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00419432
- Sponsor's protocol ID
- 1000009387
- Status last verified
- Feb 2021
- First submitted
- 5 Jan 2007
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00419432
- Acronym / sponsor ID
- 1000009387
- Conditions
- Cerebral Palsy
- Keywords
- Pediatrics, Cerebral Palsy, Gait Analysis, Orthopedic Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Aug 2019 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 8 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Establish the feasibility of implementing the randomized trial study design in multiple centres
- Estimate recruitment rates and timelines
- Establish responsiveness of outcome measures to finalize the primary \& secondary outcomes
- Estimate effect sizes of functional outcomes for sample size calculations
- Establish data management system (web-based database) for definitive multi-centre study.
- 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:
- Does the addition of gait analysis alter surgical decisions made from video observation alone, when performed in the setting of this pilot trial?
- Evaluate the consistency of the surgical decision making: intra- \& inter rater reliability
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Group A (standard pre-operative analysis) |
| 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 | Other | Group B (additional pre-operative analysis) |
Primary outcome
General Effect Size of Secondary Outcomes
Time frame: Post Study
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.
7 secondary outcomes
Gross Motor Function Measure (GMFM-66)
Time frame: Baseline, 6, 12, 24 months follow up
Pediatric Outcomes Data Collection Instrument(PODCI)
Time frame: Baseline, 6, 12, 24 months follow up
Gillette Functional Assessment Questionnaire (FAQ)
Time frame: Baseline, 6, 12, 24 months follow up
Functional Mobility Scale (FMS)
Time frame: Baseline, 6, 12, 24 months follow up
Activity Scale for Kids (ASK)
Time frame: Baseline, 6, 12, 24 months follow up
Gillette Gait (Normalcy) Index (GGI)
Time frame: Baseline, 6, 12, 24 months follow up
Gait Parameters
Time frame: Baseline, 12-, 24-months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Unni Narayanan, MBBS, MSc, FRCSC principal investigator
The Hospital for Sick Children, Toronto Canada
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine Observational Analysis (prior to procedure) and Routine Observational analysis supplemented with Gait Lab Information (prior to procedure) in people with Cerebral Palsy, run by The Hospital for Sick Children at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Effect Size of Secondary Outcomes (time frame: Post Study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.