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).

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injury/Damage
• Intervention / Treatment: Procedure: BWSTT (3 days a week for maximum of 20 minutes session)

• Study Type: Interventional
• Enrollment (Anticipated): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Ioannina, Greece
    • University Hospital of Ioannina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 88 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WISCI II	Change of walking independence at six weeks	At the time of Admittance to the rehabilitation department (at baseline) and after six weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ASIA standard neurological classification for spinal cord injury patients working sheet	Change of neurological impairment status at six weeks	At the time of Admittance to the rehabilitation department (at baseline) and after six weeks
Modified Ashworth scale	Change of spasticity of leg muscles at six weeks	At the time of Admittance to the rehabilitation department (at baseline) and after six weeks
WHOQOL-BREF	Change of patients' perspective of life quality at six weeks	At the time of Admittance to the rehabilitation department (at baseline) and after six weeks
10-item Modified Barthel Index	Change of function at six weeks	At the time of Admittance to the rehabilitation department (at baseline) and after six weeks
DXA scan	Change of BMD of hip and spine at six weeks	At the time of Admittance to the rehabilitation department (at baseline) and after six weeks
Full Body DXA scan	Change of body tissue consistency at six weeks	At the time of Admittance to the rehabilitation department (at baseline) and after 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	At the time of Admittance to the rehabilitation department (at baseline) and after six weeks

Collaborators and Investigators

• Sponsor: University of Ioannina

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: January 7, 2014
• First Submitted That Met QC Criteria: January 7, 2014
• First Posted (Estimate): January 9, 2014

Study Record Updates

• Last Update Posted (Actual): November 3, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Body Weight; Spinal Cord Injuries
• Other Study ID Numbers: UIoannina612014