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

NCT ID: NCT02031835

Last Updated: 2020-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2020-03-31

Brief Summary

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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

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Conditions

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Spinal Cord Injury/Damage

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

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

Intervention Type PROCEDURE

Interventions

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

88 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ioannina

OTHER

Sponsor Role lead

Responsible Party

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Avraam Ploumis

Principal Invastigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital of Ioannina

Ioannina, , Greece

Site Status

Countries

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Greece

Other Identifiers

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UIoannina612014

Identifier Type: -

Identifier Source: org_study_id