Cerebral PalsyPhase 2NCT00114075
Effects of Walking Analysis on Surgical Outcomes
A Phase 2 study testing Surgery with gait analysis report and Surgery without gait analysis report in people with Cerebral Palsy, run by Agency for Healthcare Research and Quality (AHRQ) at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the effects of pre-operative gait analysis testing on surgical outcomes in children with cerebral palsy who have problems walking. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Surgery with gait analysis report and Surgery without gait analysis report
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2005to Jul 2010
- Phase
- Phase 2
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of cerebral palsy
- Able to walk
- Under evaluation for orthopedic surgery to correct walking problem(s)
Who cannot join
- Orthopaedic surgery in past 1 year
- Injection of botulinum toxin in past 6 months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Shriners Hospital for Children, Los Angeles
Los Angeles, California, 90020
Childrens Hospital Los Angeles
Los Angeles, California, 90027
About this study
Official title: Impact of Gait Analysis on Surgical Outcomes
The purpose of this study is to evaluate the effects of pre-operative gait analysis testing on surgical outcomes in children with cerebral palsy who have problems walking.
Read the detailed description
Gait analysis testing has been used to assist orthopaedic surgeons in developing treatment plans for children with gait abnormalities, particularly children with cerebral palsy. Previous studies have shown that gait analysis testing significantly impacts surgical decision-making for these patients. However, no controlled studies have been done to determine whether gait analysis and the subsequent changes in surgical decision-making affect clinical outcomes. Consequently, the use of gait analysis in clinical practice remains controversial. The purpose of this study is to conduct a randomized controlled trial to assess the effects of preoperative gait analysis on surgical outcomes in ambulatory children with cerebral palsy.
Comparison: Surgery with information from gait analysis testing compared with surgery without information from gait analysis testing.
- Conditions
- Cerebral Palsy
- Being tested
- Surgery with gait analysis report, Surgery without gait analysis report
- Keywords
- gait, walking, orthopedic surgery, orthopaedic 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.
Surgery with gait analysis reportProcedure or surgery
Orthopaedic surgery with access to gait analysis report
Surgery without gait analysis reportProcedure or surgery
Orthopaedic surgery without access to gait analysis report
| Study group | Role | What they receive |
|---|---|---|
| Gait analysis | Experimental | Gait analysis report is available for treatment planning Receives: Procedure: Surgery with gait analysis report |
| Control | Active comparator | Subject has gait analysis test, but report is not available for treatment planning Receives: Procedure: Surgery without gait analysis report |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in walking ability at 1 year
Measured: 1 year
Change in walking efficiency at 1 year
Measured: 1 year
Secondary outcomes (3)
Change in gross motor function at 1 year
Measured: 1 year
Change in quality of life at 1 year
Measured: 1 year
Additional treatment needed at 1 year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2005 (estimated)
- Study startJan 2005
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agency for Healthcare Research and Quality (AHRQ)
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Tishya AL Wren, Ph.D., Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00114075
- Sponsor's protocol ID
- 5R01HS014169
- Other IDs
- 5R01HS014169
- Status last verified
- Aug 2011
- First submitted
- 13 Jun 2005
- Last updated
- 18 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Kay RM, Dennis S, Rethlefsen S, Reynolds RA, Skaggs DL, Tolo VT. The effect of preoperative gait analysis on orthopaedic decision making. Clin Orthop Relat Res. 2000 Mar;(372):217-22. doi: 10.1097/00003086-200003000-00023.
PubMed 10738430
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Gait Analysis on Surgical Outcomes
- ClinicalTrials.gov ID
- NCT00114075
- Acronym / sponsor ID
- 5R01HS014169
- Conditions
- Cerebral Palsy
- Keywords
- gait, walking, orthopedic surgery, orthopaedic surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Agency for Healthcare Research and Quality (AHRQ)US federal agency
- Study start
- Jan 2005
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 14 Jun 2005 (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 study is to evaluate the effects of pre-operative gait analysis testing on surgical outcomes in children with cerebral palsy who have problems walking.
Detailed description
Gait analysis testing has been used to assist orthopaedic surgeons in developing treatment plans for children with gait abnormalities, particularly children with cerebral palsy. Previous studies have shown that gait analysis testing significantly impacts surgical decision-making for these patients. However, no controlled studies have been done to determine whether gait analysis and the subsequent changes in surgical decision-making affect clinical outcomes. Consequently, the use of gait analysis in clinical practice remains controversial. The purpose of this study is to conduct a randomized controlled trial to assess the effects of preoperative gait analysis on surgical outcomes in ambulatory children with cerebral palsy.
Comparison: Surgery with information from gait analysis testing compared with surgery without information from gait analysis testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gait analysis | Experimental | Procedure: Surgery with gait analysis reportGait analysis report is available for treatment planning |
| Control | Active comparator | Procedure: Surgery without gait analysis reportSubject has gait analysis test, but report is not available for treatment planning |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Diagnosis of cerebral palsy
- Able to walk
- Under evaluation for orthopedic surgery to correct walking problem(s)
Key exclusion criteria (2 listed)
- Orthopaedic surgery in past 1 year
- Injection of botulinum toxin in past 6 months
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 |
|---|---|---|
| Surgery with gait analysis reportOrthopaedic surgery with access to gait analysis report | Procedure or surgery | Gait analysis |
| Surgery without gait analysis reportOrthopaedic surgery without access to gait analysis report | Procedure or surgery | Control |
Primary outcome
Change in walking ability at 1 year
Time frame: 1 year
Change in walking efficiency at 1 year
Time frame: 1 year
3 secondary outcomes
Change in gross motor function at 1 year
Time frame: 1 year
Change in quality of life at 1 year
Time frame: 1 year
Additional treatment needed at 1 year
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2012.
- Background: PubMed 10738430Kay RM, Dennis S, Rethlefsen S, Reynolds RA, Skaggs DL, Tolo VT. The effect of preoperative gait analysis on orthopaedic decision making. Clin Orthop Relat Res. 2000 Mar;(372):217-22. doi: 10.1097/00003086-200003000-00023.
- United Cerebral PalsyLink provided by the sponsor.
- Gait and Clinical Movement Analysis SocietyLink provided by the sponsor.
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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.
Tishya AL Wren, Ph.D. principal investigator
Children's Hospital Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Surgery with gait analysis report and Surgery without gait analysis report in people with Cerebral Palsy, run by Agency for Healthcare Research and Quality (AHRQ) at 2 sites in United States.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 18 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in walking ability at 1 year (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00114075, which also lists 1 linked publication.
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 18 Jul 2012.