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

Not Applicable
Completed
Conditions
Spinal Cord Injury/Damage
Interventions
Procedure: BWSTT (3 days a week for maximum of 20 minutes session)
Registration Number
NCT02031835
Lead Sponsor
University of Ioannina
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).

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
26
Inclusion Criteria
  • SCI
  • ASIA classification B, C or D
  • clinical stable
Exclusion Criteria
  • unstable cardiac conditions
  • epilepsy
  • autonomic dysreflexia
  • significant musculoskeletal problems in lower extremities other than SCI
  • Parkinson's disease

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
BWSTT (3 days a week for maximum of 20 minutes session)BWSTT (3 days a week for maximum of 20 minutes session)BWSTT (20 minutes of treadmill training (velocity (≥0.1km/h) and body weight support (≤40% of patients weight) according to patients capability and comfort
Primary Outcome Measures
NameTimeMethod
WISCI IIAt the time of Admittance to the rehabilitation department (at baseline) and after six weeks

Change of walking independence at six weeks

Secondary Outcome Measures
NameTimeMethod
WHOQOL-BREFAt the time of Admittance to the rehabilitation department (at baseline) and after six weeks

Change of patients' perspective of life quality at six weeks

10-item Modified Barthel IndexAt the time of Admittance to the rehabilitation department (at baseline) and after six weeks

Change of function at six weeks

DXA scanAt the time of Admittance to the rehabilitation department (at baseline) and after six weeks

Change of BMD of hip and spine at six weeks

ASIA standard neurological classification for spinal cord injury patients working sheetAt the time of Admittance to the rehabilitation department (at baseline) and after six weeks

Change of neurological impairment status at six weeks

Full Body DXA scanAt the time of Admittance to the rehabilitation department (at baseline) and after six weeks

Change of body tissue consistency at six weeks

Modified Ashworth scaleAt the time of Admittance to the rehabilitation department (at baseline) and after six weeks

Change of spasticity of leg muscles at six weeks

Hematological analysisAt the time of Admittance to the rehabilitation department (at baseline) and after six weeks

Change of blood's calcitonin, osteocalcin, 25 OH vitamin D, 1,25- (OH)2 vitamin D, ostase and parathyroid hormone concentrations at six weeks

Trial Locations

Locations (1)

University Hospital of Ioannina

🇬🇷

Ioannina, Greece

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