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Completed

NCT Number: NCT00114075

Effects of Walking 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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Childrens Hospital Los Angeles, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgery with gait analysis report

Procedure

Orthopaedic surgery with access to gait analysis report

Surgery without gait analysis report

Procedure

Orthopaedic surgery without access to gait analysis report

Primary outcomes

  1. Change in walking ability at 1 year

    Time frame: 1 year

  2. Change in walking efficiency at 1 year

    Time frame: 1 year

Secondary outcomes

  1. Change in gross motor function at 1 year

    Time frame: 1 year

  2. Change in quality of life at 1 year

    Time frame: 1 year

  3. Additional treatment needed at 1 year

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Agency for Healthcare Research and Quality (AHRQ)

Fed

Registry information

Official study title

Impact of Gait Analysis on Surgical Outcomes

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Jun 14, 2005
Registry last updated
Jul 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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