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Clinical Trials/NCT02031835
NCT02031835
Completed
N/A

Body Weight Supported Treadmill Training as Physical Therapy Treatment to Spinal Cord Injury Patients

University of Ioannina1 site in 1 country26 target enrollmentMarch 2012

Overview

Phase
N/A
Intervention
Not specified
Conditions
Spinal Cord Injury/Damage
Sponsor
University of Ioannina
Enrollment
26
Locations
1
Primary Endpoint
WISCI II
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The purpose of this current prospective study is to assess the effects of body weight support treadmill training (BWSTT) in individuals with spinal cord injury (SCI). Training intervention aim at improving: quality of life, walking capability, spasticity, functions in every day life, bone mass density and related hematological factors. The examination consisted of (1) neurological classification by ASIA standard neurological classification of spinal cord injury working sheet, (2) spasticity evaluation of lower limbs by Modified Ashworth Scale, (3) walking independence evaluation by Walking Index for Spinal Cord Injury II (WISCI II), (4) patient's quality of life perspective by World Health Quality of Life- BREF (WHOQOL-BREF), (5) the functional status by 10-item Modified Barthel Index, (6) bone mass density (BMD) by Dual-energy X-ray absorptiometry (DXA) scan, (7) body tissue consistency by full body DXA scan, (8) skeletal system health associated blood factors (calcitonin, osteocalcin, 25 OH vitamin D, 1,25- (OH)2 vitamin D, ostase and parathyroid hormone) by hematological tests. The results will be collected and evaluated using statistical software (i.e. SPSS).

Registry
clinicaltrials.gov
Start Date
March 2012
End Date
March 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Avraam Ploumis

Principal Invastigator

University of Ioannina

Eligibility Criteria

Inclusion Criteria

  • ASIA classification B, C or D
  • clinical stable

Exclusion Criteria

  • unstable cardiac conditions
  • autonomic dysreflexia
  • significant musculoskeletal problems in lower extremities other than SCI
  • Parkinson's disease

Outcomes

Primary Outcomes

WISCI II

Time Frame: At the time of Admittance to the rehabilitation department (at baseline) and after six weeks

Change of walking independence at six weeks

Secondary Outcomes

  • WHOQOL-BREF(At the time of Admittance to the rehabilitation department (at baseline) and after six weeks)
  • 10-item Modified Barthel Index(At the time of Admittance to the rehabilitation department (at baseline) and after six weeks)
  • DXA scan(At the time of Admittance to the rehabilitation department (at baseline) and after six weeks)
  • ASIA standard neurological classification for spinal cord injury patients working sheet(At the time of Admittance to the rehabilitation department (at baseline) and after six weeks)
  • Full Body DXA scan(At the time of Admittance to the rehabilitation department (at baseline) and after six weeks)
  • Modified Ashworth scale(At the time of Admittance to the rehabilitation department (at baseline) and after six weeks)
  • Hematological analysis(At the time of Admittance to the rehabilitation department (at baseline) and after six weeks)

Study Sites (1)

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