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Effects of Walking Analysis on Surgical Outcomes

Primary Purpose

Cerebral Palsy

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Surgery with gait analysis report

Surgery without gait analysis report

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring gait, walking, orthopedic surgery, orthopaedic surgery

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Shriners Hospital for Children, Los Angeles
Childrens Hospital Los Angeles

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Gait analysis

Control

Arm Description

Gait analysis report is available for treatment planning

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

Outcomes

Primary Outcome Measures

Change in walking ability at 1 year

Change in walking efficiency at 1 year

Secondary Outcome Measures

Change in gross motor function at 1 year

Change in quality of life at 1 year

Additional treatment needed at 1 year

Full Information

NCT ID

NCT00114075

First Posted

June 13, 2005

Last Updated

July 17, 2012

Sponsor

Agency for Healthcare Research and Quality (AHRQ)

1. Study Identification

Unique Protocol Identification Number

NCT00114075

Brief Title

Effects of Walking Analysis on Surgical Outcomes

Official Title

Impact of Gait Analysis on Surgical Outcomes

Study Type

Interventional

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Completed

Study Start Date

January 2005 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Palsy

Keywords

gait, walking, orthopedic surgery, orthopaedic surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

186 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Gait analysis

Arm Type

Experimental

Arm Description

Gait analysis report is available for treatment planning

Arm Title

Control

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Surgery with gait analysis report

Intervention Description

Orthopaedic surgery with access to gait analysis report

Intervention Type

Procedure

Intervention Name(s)

Surgery without gait analysis report

Intervention Description

Orthopaedic surgery without access to gait analysis report

Primary Outcome Measure Information:

Title

Change in walking ability at 1 year

Time Frame

1 year

Title

Change in walking efficiency at 1 year

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Change in gross motor function at 1 year

Time Frame

1 year

Title

Change in quality of life at 1 year

Time Frame

1 year

Title

Additional treatment needed at 1 year

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tishya AL Wren, Ph.D.

Organizational Affiliation

Children's Hospital Los Angeles

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shriners Hospital for Children, Los Angeles

City

Los Angeles

State/Province

California

ZIP/Postal Code

90020

Country

United States

Facility Name

Childrens Hospital Los Angeles

City

Los Angeles

State/Province

California

ZIP/Postal Code

90027

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

10738430

Citation

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.

Results Reference

background

Links:

URL

http://www.ahrq.gov/

Description

Agency for Healthcare Research and Quality

URL

http://www.ucp.org/

Description

United Cerebral Palsy

URL

http://www.gcmas.org/

Description

Gait and Clinical Movement Analysis Society

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