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

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ClinicalTrials.gov Identifier: NCT02031835
Recruitment Status : Recruiting
First Posted : January 9, 2014
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Avraam Ploumis, 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).

Condition or disease Intervention/treatment Phase
Spinal Cord Injury/Damage Procedure: BWSTT (3 days a week for maximum of 20 minutes session) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Body Weight Supported Treadmill Training as Physical Therapy Treatment to Spinal Cord Injury Patients
Study Start Date : March 2012
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Procedure: BWSTT (3 days a week for maximum of 20 minutes session)



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   8 Years to 88 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02031835


Contacts
Contact: Vasileios Christodoulou, M.Sc. 2310915910 ext +30 vchristod@cc.uoi.gr

Locations
Greece
University Hospital of Ioannina Recruiting
Ioannina, Greece
Contact: Avraam Ploumis, Phd, MD    2651099986 ext +30    aploumis@cc.uoi.gr   
Principal Investigator: Avraam Ploumis, Phd, MD         
Sub-Investigator: Vasileios Christodoulou, M.Sc.         
Sponsors and Collaborators
University of Ioannina

Responsible Party: Avraam Ploumis, Principal Invastigator, University of Ioannina
ClinicalTrials.gov Identifier: NCT02031835     History of Changes
Other Study ID Numbers: UIoannina612014
First Posted: January 9, 2014    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Body Weight
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Signs and Symptoms