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NCT Number: NCT02031835

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

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).

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Key information

Conditions

Spinal Cord Injury/Damage Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

8 year–88 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Ioannina

Ioannina, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BWSTT (3 days a week for maximum of 20 minutes session)

Procedure

Primary outcomes

  1. 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

  1. ASIA standard neurological classification for spinal cord injury patients working sheet

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

    Change of neurological impairment status at six weeks

  2. Modified Ashworth scale

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

    Change of spasticity of leg muscles at six weeks

  3. WHOQOL-BREF

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

    Change of patients' perspective of life quality at six weeks

  4. 10-item Modified Barthel Index

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

    Change of function at six weeks

  5. DXA scan

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

    Change of BMD of hip and spine at six weeks

  6. Full Body DXA scan

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

    Change of body tissue consistency at six weeks

  7. Hematological analysis

    Time frame: At 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

Sponsors and collaborators

Lead sponsor

University of Ioannina

Other

Registry information

Important dates

Study start
2012
Primary completion
2020
Study completion
2020
First posted
Jan 9, 2014
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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