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Trial record 78 of 239 for:    CALCITONIN SALMON

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02031835
Recruitment Status : Active, not recruiting
First Posted : January 9, 2014
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Avraam Ploumis, University of Ioannina

Tracking Information
First Submitted Date  ICMJE January 7, 2014
First Posted Date  ICMJE January 9, 2014
Last Update Posted Date September 26, 2019
Study Start Date  ICMJE March 2012
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02031835 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2014)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Body Weight Supported Treadmill Training as Physical Therapy Treatment to Spinal Cord Injury Patients
Official Title  ICMJE Body Weight Supported Treadmill Training as Physical Therapy Treatment to Spinal Cord Injury Patients
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Spinal Cord Injury/Damage
Intervention  ICMJE Procedure: BWSTT (3 days a week for maximum of 20 minutes session)
Study Arms  ICMJE 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
Intervention: Procedure: BWSTT (3 days a week for maximum of 20 minutes session)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 24, 2019)
26
Original Estimated Enrollment  ICMJE
 (submitted: January 7, 2014)
50
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 88 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02031835
Other Study ID Numbers  ICMJE UIoannina612014
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Avraam Ploumis, University of Ioannina
Study Sponsor  ICMJE University of Ioannina
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Ioannina
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP