Back to resultsBody Weight Supported Treadmill Training as Physical Therapy Treatment to Spinal Cord Injury Patients
Primary Purpose
Spinal Cord Injury/Damage
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
BWSTT (3 days a week for maximum of 20 minutes session)
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury/Damage
Eligibility 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
Sites / Locations
- University Hospital of Ioannina
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
BWSTT (3 days a week for maximum of 20 minutes session)
Arm Description
BWSTT (20 minutes of treadmill training (velocity (≥0.1km/h) and body weight support (≤40% of patients weight) according to patients capability and comfort
Outcomes
Primary Outcome Measures
WISCI II
Change of walking independence at six weeks
Secondary Outcome Measures
ASIA standard neurological classification for spinal cord injury patients working sheet
Change of neurological impairment status at six weeks
Modified Ashworth scale
Change of spasticity of leg muscles at six weeks
WHOQOL-BREF
Change of patients' perspective of life quality at six weeks
10-item Modified Barthel Index
Change of function at six weeks
DXA scan
Change of BMD of hip and spine at six weeks
Full Body DXA scan
Change of body tissue consistency at six weeks
Hematological analysis
Change of blood's calcitonin, osteocalcin, 25 OH vitamin D, 1,25- (OH)2 vitamin D, ostase and parathyroid hormone concentrations at six weeks
Full Information
NCT ID
NCT02031835
First Posted
January 7, 2014
Last Updated
November 2, 2020
Sponsor
University of Ioannina
1. Study Identification
Unique Protocol Identification Number
NCT02031835
Brief Title
Body Weight Supported Treadmill Training as Physical Therapy Treatment to Spinal Cord Injury Patients
Official Title
Body Weight Supported Treadmill Training as Physical Therapy Treatment to Spinal Cord Injury Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2020 (Actual)
Study Completion Date
March 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ioannina
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury/Damage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BWSTT (3 days a week for maximum of 20 minutes session)
Arm Type
Other
Arm Description
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 Type
Procedure
Intervention Name(s)
BWSTT (3 days a week for maximum of 20 minutes session)
Primary Outcome Measure Information:
Title
WISCI II
Description
Change of walking independence at six weeks
Time Frame
At the time of Admittance to the rehabilitation department (at baseline) and after six weeks
Secondary Outcome Measure Information:
Title
ASIA standard neurological classification for spinal cord injury patients working sheet
Description
Change of neurological impairment status at six weeks
Time Frame
At the time of Admittance to the rehabilitation department (at baseline) and after six weeks
Title
Modified Ashworth scale
Description
Change of spasticity of leg muscles at six weeks
Time Frame
At the time of Admittance to the rehabilitation department (at baseline) and after six weeks
Title
WHOQOL-BREF
Description
Change of patients' perspective of life quality at six weeks
Time Frame
At the time of Admittance to the rehabilitation department (at baseline) and after six weeks
Title
10-item Modified Barthel Index
Description
Change of function at six weeks
Time Frame
At the time of Admittance to the rehabilitation department (at baseline) and after six weeks
Title
DXA scan
Description
Change of BMD of hip and spine at six weeks
Time Frame
At the time of Admittance to the rehabilitation department (at baseline) and after six weeks
Title
Full Body DXA scan
Description
Change of body tissue consistency at six weeks
Time Frame
At the time of Admittance to the rehabilitation department (at baseline) and after six weeks
Title
Hematological analysis
Description
Change of blood's calcitonin, osteocalcin, 25 OH vitamin D, 1,25- (OH)2 vitamin D, ostase and parathyroid hormone concentrations at six weeks
Time Frame
At the time of Admittance to the rehabilitation department (at baseline) and after six weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University Hospital of Ioannina
City
Ioannina
Country
Greece
12. IPD Sharing Statement
Learn more about this trial
Body Weight Supported Treadmill Training as Physical Therapy Treatment to Spinal Cord Injury Patients
We'll reach out to this number within 24 hrs