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Body Weight Support in Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT02703883
Recruitment Status : Completed
First Posted : March 9, 2016
Last Update Posted : March 9, 2016
Sponsor:
Information provided by (Responsible Party):
Rodrigo Torres, University of Chile

Brief Summary:
The purpose of this study was to evaluate the effectiveness of body weight-supported treadmill (BWST) training on static balance impairment in adults with incomplete spinal cord injury (SCI) in chronic stage

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Device: BWST Not Applicable

Detailed Description:
The individuals who participated in this study were subjects with SCI with more than twelve months of evolution. All were classified as incomplete injury class C or D according to the American Spinal Injury Association (ASIA). Each received training on a BWST for six weeks. Two measures of stance balance were performed during the training protocol. The first measure was made before entering the training protocol; the final measure was implemented once the gait training on BWST protocol was completed. For instrumented stance balance testing, small wireless inertial motion sensors (OPAL sensors, APDM Inc., Portland, OR) were placed on the subjects' waist. Subjects performed instrumented stance with their eyes opened (iSway). Outcome measures were recorded and automatically generated using Mobility Lab software (APDM Inc., Portland, OR). Measures included the root mean square of sway and jerk (normalized to the range of acceleration amplitude).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Effects of Body Weight-supported Treadmill Training on Center of Mass Control in Spinal Cord Injury, Measured With Inertial Sensors
Study Start Date : July 2012
Actual Primary Completion Date : November 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Body Weight Support
Treatment protocol consisted of 18 training sessions on the BWST, three times a week, every session included three sets of six minutes of locomotion with rest intervals of 2 min of rest.
Device: BWST
BWST (six weeks, 3 times/week)




Primary Outcome Measures :
  1. Jerk (Derivative of the acceleration of the mass center as marker oscillation of the control the center of mass) [ Time Frame: 6 weeks ]
    The jerk is measure with a instrumented stance testing. For this test, we use small wireless inertial sensors (OPAL sensor, APDM, Inc. Portland, OR). This outcome is recorded automatically generated using Mobility Lab Software (APDM Inc., Portland, OR).


Secondary Outcome Measures :
  1. Walking Index for Spinal Cord Injury (WISCI) scale [ Time Frame: 6 weeks ]
    The WISCI is a walking scale, that measures the independence of walking based on the use of devices.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • SCI with more than twelve months of evolution.
  • ASIA C and D

Exclusion Criteria:

  • Patients with tracheostomy
  • Patients with severe respiratory, cognitive and cardiovascular comorbidities
  • Patients with peripheral nerve injury in lower limbs
  • Patients with traumatic head injury

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02703883


Locations
Chile
Clínica Los Coihues
Santiago, Región Metropolitana, Chile
Sponsors and Collaborators
University of Chile
Investigators
Principal Investigator: Felipe Covarrubias Clinica Los Coihues

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rodrigo Torres, MSc, University of Chile
ClinicalTrials.gov Identifier: NCT02703883     History of Changes
Other Study ID Numbers: CLC-1
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: March 9, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Body Weight
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Signs and Symptoms