NCT00154505

Brief Summary

The effects of lateral trunk supports (LTS) in special seating on the spinal alignment of 17 spinal cord injured (SCI) subjects with scoliosis were studied using bi-planar radiographs. The LTS improved significantly the functional scoliotic spinal alignment in the frontal and sagittal planes regardless of the severity of scoliosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2002

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, 2002

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
10 months 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
Last Updated

September 12, 2005

Status Verified

August 1, 2002

First QC Date

September 9, 2005

Last Update Submit

September 9, 2005

Conditions

ScoliosisSpinal Cord Injury

Keywords

ScoliosisSpinal Cord InjuryLateral Trunk SupportRadiography

Outcome Measures

Primary Outcomes (1)

  • Spinal aligamnet(Cobb angle)

Interventions

Lateral trunk support of wheelchair seatingDEVICE

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • (1) C4-T12 SCI, (2) onset over 1 year, (3) sitting on the wheelchair more than 4 hours per day, (4) diagnosed thoracic or lumbar scoliosis through A-P radiographs, (5) flexible scoliosis, confirmed by supine and side-lying bending radiographs.

You may not qualify if:

  • inflexible scoliosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Occupational Therapy, National Taiwan University

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

ScoliosisSpinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal DiseasesSpinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Hui-Fen Mao, MS

    National Taiwan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 12, 2005

Study Start

September 1, 2002

Study Completion

November 1, 2004

Last Updated

September 12, 2005

Record last verified: 2002-08

Locations

TW(1)