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Completed

NCT Number: NCT02703883

Body Weight Support in Spinal Cord Injury

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

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Clínica Los Coihues

Santiago, Santiago Metropolitan, Chile

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BWST

Device

BWST (six weeks, 3 times/week)

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 9, 2016
Registry last updated
Mar 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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