Body Weight Support in Spinal Cord Injury

Spinal Cord Injury Clinical Trial

Official title:

Effects of Body Weight-supported Treadmill Training on Center of Mass Control in Spinal Cord Injury, Measured With Inertial Sensors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02703883
• Other study ID #: CLC-1
• Status: Completed
• Phase: N/A
• First received: February 29, 2016
• Last updated: March 3, 2016
• Start date: July 2012
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: University of Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Comité de Bioética
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Body Weight
• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Device:
• BWST
BWST (six weeks, 3 times/week)

Locations

Country	Name	City	State
Chile	Clínica Los Coihues	Santiago	Región Metropolitana

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	6 weeks	Yes
Secondary	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.	6 weeks	Yes