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

NCT02031835 | Completed

• 1 other identifier: UIoannina612014
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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).

Conditions

Spinal Cord Injury/Damage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• ASIA standard neurological classification for spinal cord injury patients working sheet

  At the time of Admittance to the rehabilitation department (at baseline) and after six weeks

• Modified Ashworth scale

  At the time of Admittance to the rehabilitation department (at baseline) and after six weeks

• WHOQOL-BREF

  At the time of Admittance to the rehabilitation department (at baseline) and after six weeks

• 10-item Modified Barthel Index

  At the time of Admittance to the rehabilitation department (at baseline) and after six weeks

• DXA scan

  At the time of Admittance to the rehabilitation department (at baseline) and after six weeks

Study Arms (1)

BWSTT (3 days a week for maximum of 20 minutes session)

OTHER

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)

Interventions

BWSTT (3 days a week for maximum of 20 minutes session) PROCEDURE

BWSTT (3 days a week for maximum of 20 minutes session)

Eligibility Criteria

• Age: 8 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• SCI
• ASIA classification B, C or D
• clinical stable

You may not qualify if:

• unstable cardiac conditions
• epilepsy
• autonomic dysreflexia
• significant musculoskeletal problems in lower extremities other than SCI
• Parkinson's disease

Sponsors & Collaborators

• University of Ioannina: lead

Study Sites (1)

University Hospital of Ioannina

Ioannina, Greece

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Invastigator

Study Record Dates

• First Submitted: January 7, 2014
• First Posted: January 9, 2014
• Study Start: March 1, 2012
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: November 3, 2020

Record last verified: 2020-11

Locations

GR (1)