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

This study has been completed.
Sponsor:
Collaborator:
DePuy Spine
Information provided by (Responsible Party):
Sahar Hassani, Shriners Hospitals for Children
ClinicalTrials.gov Identifier:
NCT01109082
First received: April 15, 2010
Last updated: March 18, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Scoliosis
Procedure: posterior spine fusion

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gait and Postural Stability Assessment in Children With Idiopathic Scoliosis Undergoing Posterior Spine Instrumentation

Resource links provided by NLM:


Further study details as provided by Shriners Hospitals for Children:

Primary Outcome Measures:
  • Motion Analysis [ Time Frame: Pre-Operation visit (within 1 week prior to surgical date) ] [ Designated as safety issue: No ]
    Gait and standing spine range of motion are measured using a 3-D motion capture system.

  • Motion Analysis [ Time Frame: 1 Year Post-Operative ] [ Designated as safety issue: No ]
    Gait and standing spine range of motion are measured using a 3-D motion capture system.

  • Motion Analysis [ Time Frame: 2 Years Post-Operative ] [ Designated as safety issue: No ]
    Gait and standing spine range of motion are measured using a 3-D motion capture system.


Secondary Outcome Measures:
  • Functional Questionnaires [ Time Frame: Collected at Pre-Operative visit (1 week prior to surgical date) ] [ Designated as safety issue: No ]
    A functional outcome questionnaire filled out by the parents and patient.

  • Functional Questionnaires [ Time Frame: Collected at 1 year post-operative visit ] [ Designated as safety issue: No ]
    A functional outcome questionnaire filled out by the parents and patient.

  • e-med plantar pressures [ Time Frame: Collected at Pre-Operative visit (1 week prior to surgical visit) ] [ Designated as safety issue: No ]
    A pressure map of the plantar surface of the foot during walking.

  • Postural Stability [ Time Frame: Pre-Operative (1 week prior to surgical visit) ] [ Designated as safety issue: No ]
    Standing balance and postural stability are measured using a NeuroCom Equitest System and Twin Forceplate system.

  • Functional Questionnaires [ Time Frame: Collected at 2 year follow up ] [ Designated as safety issue: No ]
    A functional outcome questionnaire filled out by the parents and patient.

  • e-med plantar pressures [ Time Frame: Collected at 1 year follow up ] [ Designated as safety issue: No ]
    A pressure map of the plantar surface of the foot during walking.

  • e-med plantar pressure [ Time Frame: 2 year follow up ] [ Designated as safety issue: No ]
    A pressure map of the plantar surface of the foot during walking.

  • Postural Stability [ Time Frame: 1 Year post-operative visit ] [ Designated as safety issue: No ]
    Standing balance and postural stability are measured using a NeuroCom Equitest System and Twin Forceplate system.

  • Postural Stability [ Time Frame: 2 year post-operative follow up ] [ Designated as safety issue: No ]
    Standing balance and postural stability are measured using a NeuroCom Equitest System and Twin Forceplate system.


Enrollment: 42
Study Start Date: December 2007
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Adolescents with idiopathic scoliosis
Adolescents with idiopathic scoliosis
Procedure: posterior spine fusion
vertebrae are fused to straighten a spinal curve

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.

  Eligibility

Ages Eligible for Study:   1 Year to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01109082

Locations
United States, Illinois
Shriners Hospitals for Children
Chicago, Illinois, United States, 60707
Sponsors and Collaborators
Shriners Hospitals for Children
DePuy Spine
Investigators
Principal Investigator: Sahar Hassani, MS Shriners Hosptials for Children
  More Information

No publications provided

Responsible Party: Sahar Hassani, Research Administrator, Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT01109082     History of Changes
Other Study ID Numbers: AIS-2010
Study First Received: April 15, 2010
Last Updated: March 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Shriners Hospitals for Children:
Scoliosis
gait
posture
balance

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 22, 2014