Effects of Walking Analysis on Surgical Outcomes

Agency for Healthcare Research and Quality (AHRQ)

Status and phase: Completed; Phase 2

Conditions: Cerebral Palsy

Treatments: Procedure: Surgery with gait analysis report; Procedure: Surgery without gait analysis report

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00114075

5R01HS014169 (U.S. AHRQ Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 186 patients

Sex: All

Ages: 3 to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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186 participants in 2 patient groups

Gait analysis

Experimental group

Description:

Gait analysis report is available for treatment planning

Treatment:

Procedure: Surgery with gait analysis report

Control

Active Comparator group

Description:

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

Treatment:

Procedure: Surgery without gait analysis report