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Effects of Lateral Trunk Support on Spinal Alignment in Spinal Cord Injured Persons

Primary Purpose

Scoliosis, Spinal Cord Injury

Status
Completed
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
Lateral trunk support of wheelchair seating
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scoliosis focused on measuring Scoliosis, Spinal Cord Injury, Lateral Trunk Support, Radiography

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: (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. Exclusion Criteria: inflexible scoliosis

Sites / Locations

  • School of Occupational Therapy, National Taiwan University

Outcomes

Primary Outcome Measures

Spinal aligamnet(Cobb angle)

Secondary Outcome Measures

Full Information

First Posted
September 9, 2005
Last Updated
September 9, 2005
Sponsor
National Taiwan University Hospital
Collaborators
National Science Council, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT00154505
Brief Title
Effects of Lateral Trunk Support on Spinal Alignment in Spinal Cord Injured Persons
Official Title
Effects of Lateral Trunk Support on Spinal Alignment in Spinal Cord Injured Persons
Study Type
Interventional

2. Study Status

Record Verification Date
August 2002
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Taiwan University Hospital
Collaborators
National Science Council, Taiwan

4. Oversight

5. Study Description

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.
Detailed Description
SCI patients often develop progressive scoliosis due to loss of muscular support to maintain good sitting posture. Special seating with LTS has been widely used in clinical practice to improve their sitting postures. However, little is known as to how this can affect the scoliotic curve.The purpose of this study was to investigate the effects of lateral trunk supports (LTS) in special seating on the spinal alignment of spinal cord injured (SCI) individuals with scoliosis. Ten male and seven female SCI subjects with scoliosis sat on an experimental chair with and without LTS while radiographs of the spine in the anteroposterior and lateral directions were taken. Radiographs of the spine in the A-P and lateral directions were taken with a digital radiographic imaging system (Saturn 9000 M, Comed., Korea). For each direction, the complete image of the spine was obtained from separate x-ray images of the upper and lower trunk due to the limited field of view of the x-ray machine. The Cobb angles and scoliotic indices based on the anteroposterior radiographic images and the angles of the thoracic and lumber spine based on lateral were calculated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis, Spinal Cord Injury
Keywords
Scoliosis, Spinal Cord Injury, Lateral Trunk Support, Radiography

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Lateral trunk support of wheelchair seating
Primary Outcome Measure Information:
Title
Spinal aligamnet(Cobb angle)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: (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. Exclusion Criteria: inflexible scoliosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui-Fen Mao, MS
Organizational Affiliation
National Taiwan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Occupational Therapy, National Taiwan University
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

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Effects of Lateral Trunk Support on Spinal Alignment in Spinal Cord Injured Persons

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