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

NCT01109082 · View on ClinicalTrials.gov ↗

Study 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 Studied

Interventions

  • PROCEDURE posterior spine fusion

Study Locations (1)

Illinois

  • Shriners Hospitals for Children — Chicago

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 2007-12
Est. Completion 2012-12

Sponsor

Shriners Hospitals for Children

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01109082

The ClinicalTrials.gov registry entry for NCT01109082 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shriners Hospitals for Children, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Scoliosis appearing as the primary indexed condition, and to 1 intervention — of which posterior spine fusion is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01109082 reports 1 study location spanning 1 distinct geographic area — top geographies include Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01109082 about?

NCT01109082 is a clinical study titled "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, postur...

What is the current status of trial NCT01109082?

This trial is currently completed. The enrollment target is 42 participants. The study started on 2007-12. Estimated completion is 2012-12.

What conditions does trial NCT01109082 study?

This clinical trial studies the following conditions: Scoliosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01109082?

The interventions under investigation include: posterior spine fusion (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01109082?

This trial is sponsored by Shriners Hospitals for Children, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01109082 being conducted?

This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial