Back to resultsBody Weight Support in Spinal Cord Injury
Primary Purpose
Spinal Cord Injury
Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
BWST
Sponsored by
About this trial
This is an interventional diagnostic trial for Spinal Cord Injury
Eligibility 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
Sites / Locations
- Clínica Los Coihues
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Body Weight Support
Arm Description
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.
Outcomes
Primary Outcome Measures
Jerk (Derivative of the acceleration of the mass center as marker oscillation of the control the center of mass)
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
Walking Index for Spinal Cord Injury (WISCI) scale
The WISCI is a walking scale, that measures the independence of walking based on the use of devices.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02703883
Brief Title
Body Weight Support in Spinal Cord Injury
Official Title
Effects of Body Weight-supported Treadmill Training on Center of Mass Control in Spinal Cord Injury, Measured With Inertial Sensors
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Chile
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Body Weight Support
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
BWST
Intervention Description
BWST (six weeks, 3 times/week)
Primary Outcome Measure Information:
Title
Jerk (Derivative of the acceleration of the mass center as marker oscillation of the control the center of mass)
Description
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).
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Walking Index for Spinal Cord Injury (WISCI) scale
Description
The WISCI is a walking scale, that measures the independence of walking based on the use of devices.
Time Frame
6 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felipe Covarrubias
Organizational Affiliation
Clinica Los Coihues
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clínica Los Coihues
City
Santiago
State/Province
Región Metropolitana
Country
Chile
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29058553
Citation
Covarrubias-Escudero F, Rivera-Lillo G, Torres-Castro R, Varas-Diaz G. Effects of body weight-support treadmill training on postural sway and gait independence in patients with chronic spinal cord injury. J Spinal Cord Med. 2019 Jan;42(1):57-64. doi: 10.1080/10790268.2017.1389676. Epub 2017 Oct 23.
Results Reference
derived
Learn more about this trial
Body Weight Support in Spinal Cord Injury
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