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Effects of Walking Analysis on Surgical Outcomes

Impact of Gait Analysis on Surgical Outcomes

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00114075
Enrollment
186
Registered
2005-06-14
Start date
2005-01-31
Completion date
2010-07-31
Last updated
2012-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy

Keywords

gait, walking, orthopedic surgery, orthopaedic surgery

Brief 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.

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.

Interventions

PROCEDURESurgery with gait analysis report

Orthopaedic surgery with access to gait analysis report

PROCEDURESurgery without gait analysis report

Orthopaedic surgery without access to gait analysis report

Sponsors

Agency for Healthcare Research and Quality (AHRQ)
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* Diagnosis of cerebral palsy * Able to walk * Under evaluation for orthopedic surgery to correct walking problem(s)

Exclusion criteria

* Orthopaedic surgery in past 1 year * Injection of botulinum toxin in past 6 months

Design outcomes

Primary

MeasureTime frame
Change in walking ability at 1 year1 year
Change in walking efficiency at 1 year1 year

Secondary

MeasureTime frame
Change in gross motor function at 1 year1 year
Change in quality of life at 1 year1 year
Additional treatment needed at 1 year1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026