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Effects of Walking Analysis on Surgical Outcomes

NCT ID: NCT00114075

Last Updated: 2012-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2010-07-31

Brief Summary

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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

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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

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Cerebral Palsy

Keywords

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gait walking orthopedic surgery orthopaedic surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Gait analysis

Gait analysis report is available for treatment planning

Group Type EXPERIMENTAL

Surgery with gait analysis report

Intervention Type PROCEDURE

Orthopaedic surgery with access to gait analysis report

Control

Subject has gait analysis test, but report is not available for treatment planning

Group Type ACTIVE_COMPARATOR

Surgery without gait analysis report

Intervention Type PROCEDURE

Orthopaedic surgery without access to gait analysis report

Interventions

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Surgery with gait analysis report

Orthopaedic surgery with access to gait analysis report

Intervention Type PROCEDURE

Surgery without gait analysis report

Orthopaedic surgery without access to gait analysis report

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tishya AL Wren, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Los Angeles

Locations

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Shriners Hospital for Children, Los Angeles

Los Angeles, California, United States

Site Status

Childrens Hospital Los Angeles

Los Angeles, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 10738430 (View on PubMed)

Related Links

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http://www.ucp.org/

United Cerebral Palsy

http://www.gcmas.org/

Gait and Clinical Movement Analysis Society

Other Identifiers

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5R01HS014169

Identifier Type: AHRQ

Identifier Source: secondary_id

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5R01HS014169

Identifier Type: AHRQ

Identifier Source: org_study_id

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