Body Weight Support in Spinal Cord Injury
March 3, 2016 updated by: Rodrigo Torres, University of Chile
Effects of Body Weight-supported Treadmill Training on Center of Mass Control in Spinal Cord Injury, Measured With Inertial Sensors
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
Study Overview
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
Enrollment (Actual)
17
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Región Metropolitana
-
Santiago, Región Metropolitana, Chile
- Clínica Los Coihues
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
BWST (six weeks, 3 times/week)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Felipe Covarrubias, Clínica Los Coihues
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Actual)
November 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
February 29, 2016
First Submitted That Met QC Criteria
March 3, 2016
First Posted (Estimate)
March 9, 2016
Study Record Updates
Last Update Posted (Estimate)
March 9, 2016
Last Update Submitted That Met QC Criteria
March 3, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLC-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.