Gait and Postural Stability Assessment in Children With Idiopathic Scoliosis Undergoing Posterior Spine Instrumentation

NCT01109082 | Completed DMC

• 1 other identifier: AIS-2010
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate children and adolescents with idiopathic scoliosis who are undergoing spinal fusion using motion analysis, balance, and outcome questionnaires. Little research has been done to evaluate how different fusion levels impact walking patterns, range of motion, posture and balance following spine instrumentation in children with idiopathic scoliosis. Debate still continues whether posterior spinal instrumentation with the last instrumented vertebra at or above Lumbar 3 (L3) will provide sufficient spine correction, greater motion, and better posture and balance when compared to a child with instrumentation at Lumbar 4 (L4). Furthermore, how does the spine fusion endpoint (last instrumented vertebra) impact quality of life, participation, and impairment in children and adolescents with idiopathic scoliosis and how do they compare to healthy age-matched peers. The goal of this study is to compare these two end points using gait analysis, postural stability, and outcome tools with the hopes of providing better clinical care to children with idiopathic scoliosis.

Conditions

Scoliosis

Keywords

Scoliosis; gait; posture; balance

Outcome Measures

Primary Outcomes (3)

• Motion Analysis

  Gait and standing spine range of motion are measured using a 3-D motion capture system.

  Pre-Operation visit (within 1 week prior to surgical date)

• Motion Analysis

  Gait and standing spine range of motion are measured using a 3-D motion capture system.

  1 Year Post-Operative

• Motion Analysis

  Gait and standing spine range of motion are measured using a 3-D motion capture system.

  2 Years Post-Operative

Secondary Outcomes (9)

• Functional Questionnaires

  Collected at Pre-Operative visit (1 week prior to surgical date)

• Functional Questionnaires

  Collected at 1 year post-operative visit

• e-med plantar pressures

  Collected at Pre-Operative visit (1 week prior to surgical visit)

• Postural Stability

  Pre-Operative (1 week prior to surgical visit)

• Functional Questionnaires

  Collected at 2 year follow up

Study Arms (1)

Adolescents with idiopathic scoliosis

Adolescents with idiopathic scoliosis

Procedure: posterior spine fusion

Interventions

posterior spine fusion PROCEDURE

vertebrae are fused to straighten a spinal curve

Adolescents with idiopathic scoliosis

Eligibility Criteria

• Age: 1 Year - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adolescents with idiopathic scoliosis that have a Cobb angle greater than 50 degrees.

You may qualify if:

• idiopathic scoliosis
• between the ages of 10 - 20
• need a spine fusion at L4 or above
• can walk on your own
• have not had surgery on spine before

You may not qualify if:

• pregnant

Sponsors & Collaborators

• Shriners Hospitals for Children: lead
• DePuy Spine: collaborator

Study Sites (1)

Shriners Hospitals for Children

Chicago, Illinois, 60707, United States

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Sahar Hassani, MS

  Shriners Hosptials for Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Administrator

Study Record Dates

• First Submitted: April 15, 2010
• First Posted: April 22, 2010
• Study Start: December 1, 2007
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 19, 2013

Record last verified: 2013-03

Locations

US (1)