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

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.

Study Overview

• Status: Completed
• Conditions: Scoliosis
• Intervention / Treatment: Procedure: posterior spine fusion

Detailed Description

The study population will include sixty (60) children with idiopathic scoliosis who will undergo spine surgery and sixty (60) developing children "Control Group". Scoliosis patients will undergo a period of testing which requires three visits: pre-operative evaluation, one-year post-operative evaluation, and two-year post-operative evaluation. The Control Group will require one initial assessment. A total of 240 evaluations will be performed over a three-year period. We will evaluate the correlation among outcome tools and quantitative measures in order to determine how these instruments can be used more effectively for better treatment. Subjects and their parents will be fully informed of the nature of the study as well as the potential risk involved and sign the appropriate consent form. The study will be reviewed by the IRB and include HIPAA compliance. This will be accomplished during testing at the Shriners Hospital for Children- Chicago Motion Analysis Lab. All possible steps will be taken to assure the safety and convenience of the study participants. All subjects will be evaluated using clinical outcome tools (PODCI, SF-36) and will undergo quantitative 3-D motion analysis and postural stability assessment. Quantitative 3-D gait analysis will be done with our 14-camera Motion Capture system and passive reflective markers (Figure 3). Motion analysis will be performed with each subject walking at a comfortable and natural speed on the laboratory walkway. Passive markers will be attached to anatomic landmarks in standardized locations using double-backed tape. Marker coordinate data will be used to determine range of motion and joint angles.

Four forceplates will be used to measure kinetic data and static balance. Postural stability testing will be performed on all subjects (Figure 4). We will evaluate responses to dynamic stability challenges that investigates motor and sensory control and adaptation to perturbations. Static (quiet standing) postural stability tests will be done on all subjects. A licensed physical therapist (PT) will perform the exam following the protocol of the Shriners Hospital for Children's motion lab.

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60707
      • Shriners Hospitals for Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• pregnant

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adolescents with idiopathic scoliosis	Procedure: posterior spine fusion; vertebrae are fused to straighten a spinal curve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Questionnaires	A functional outcome questionnaire filled out by the parents and patient.	Collected at Pre-Operative visit (1 week prior to surgical date)
Functional Questionnaires	A functional outcome questionnaire filled out by the parents and patient.	Collected at 1 year post-operative visit
e-med plantar pressures	A pressure map of the plantar surface of the foot during walking.	Collected at Pre-Operative visit (1 week prior to surgical visit)
Postural Stability	Standing balance and postural stability are measured using a NeuroCom Equitest System and Twin Forceplate system.	Pre-Operative (1 week prior to surgical visit)
Functional Questionnaires	A functional outcome questionnaire filled out by the parents and patient.	Collected at 2 year follow up
e-med plantar pressures	A pressure map of the plantar surface of the foot during walking.	Collected at 1 year follow up
e-med plantar pressure	A pressure map of the plantar surface of the foot during walking.	2 year follow up
Postural Stability	Standing balance and postural stability are measured using a NeuroCom Equitest System and Twin Forceplate system.	1 Year post-operative visit
Postural Stability	Standing balance and postural stability are measured using a NeuroCom Equitest System and Twin Forceplate system.	2 year post-operative follow up

Collaborators and Investigators

• Sponsor: Shriners Hospitals for Children
• Collaborators: DePuy Spine
• Investigators: Principal Investigator: Sahar Hassani, MS, Shriners Hosptials for Children

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: April 15, 2010
• First Submitted That Met QC Criteria: April 21, 2010
• First Posted (Estimate): April 22, 2010

Study Record Updates

• Last Update Posted (Estimate): March 19, 2013
• Last Update Submitted That Met QC Criteria: March 18, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: gait; Scoliosis; balance; posture
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: AIS-2010