Clinical trial NCT02031835: 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
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury/Damage
Lead sponsor: University of Ioannina
Sponsor class: OTHER
First posted: 2014-01-09
Enrollment: 26
Sex: ALL
Minimum age (years): 8
Maximum age (years): 88
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: WISCI II
timeFrame: At the time of Admittance to the rehabilitation department (at baseline) and after six weeks
Secondary outcomes:
measure: ASIA standard neurological classification for spinal cord injury patients working sheet
timeFrame: At the time of Admittance to the rehabilitation department (at baseline) and after six weeks
measure: Modified Ashworth scale
timeFrame: At the time of Admittance to the rehabilitation department (at baseline) and after six weeks
measure: WHOQOL-BREF
timeFrame: At the time of Admittance to the rehabilitation department (at baseline) and after six weeks
measure: 10-item Modified Barthel Index
timeFrame: At the time of Admittance to the rehabilitation department (at baseline) and after six weeks
measure: DXA scan
timeFrame: At the time of Admittance to the rehabilitation department (at baseline) and after six weeks
measure: Full Body DXA scan
timeFrame: At the time of Admittance to the rehabilitation department (at baseline) and after six weeks
measure: Hematological analysis
timeFrame: At the time of Admittance to the rehabilitation department (at baseline) and after six weeks
Other outcomes:
Locations:
city: Ioannina
country: Greece
facility: University Hospital of Ioannina
Study officials:
References: