NCT00155545

Brief Summary

The purposes of this study are to use motion analysis techniques to study the biomechanical interactions between the spine and the lower limbs in scoliosis patients with or without leg length discrepancy (LLD) during activity; to investigate the effects of correction of LLD: using foot orthosis on the functional scoliotic spinal curve and motion during functional activity; and to test whether idiopathic scoliosis without LLD can be improved by artificially creating a leg length discrepancy with a foot orthosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2005

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

December 10, 2012

Status Verified

November 1, 2012

Enrollment Period

3 years

First QC Date

September 9, 2005

Last Update Submit

December 6, 2012

Conditions

Leg Length DiscrepancyScoliosis

Keywords

functional scoliosisidiopathic scoliosisleg length discrepancymotion analysisbiomechanics

Outcome Measures

Primary Outcomes (2)

  • Variation of spine angle

    30

  • Variation of spine shape

    30

Study Arms (1)

Metformin

NO INTERVENTION
Behavioral: Motion analysis of patients

Interventions

Motion analysis of patientsBEHAVIORAL
Metformin

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Functional scoliosis patients who have lumbar scoliosis combined with significant structural LLD
  • Adolescent idiopathic lumbar scoliosis patients without LLD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Leg Length InequalityScoliosis

Condition Hierarchy (Ancestors)

Bone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSpinal CurvaturesSpinal Diseases

Study Officials

  • Shier-Chieg Huang, MD

    Department of Orthopaedics, National Taiwan University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 12, 2005

Study Start

September 1, 2005

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

December 10, 2012

Record last verified: 2012-11

Locations

TW(1)