NCT02703883

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 29, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 9, 2016

Completed
Last Updated

March 9, 2016

Status Verified

March 1, 2016

Enrollment Period

3.3 years

First QC Date

February 29, 2016

Last Update Submit

March 3, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Walking Index for Spinal Cord Injury (WISCI) scale

    6 weeks

Study Arms (1)

Body Weight Support

EXPERIMENTAL

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

Interventions

BWSTDEVICE

BWST (six weeks, 3 times/week)

Body Weight Support

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clínica Los Coihues

Santiago, Santiago Metropolitan, Chile

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Felipe Covarrubias

    Clinica Los Coihues

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

February 29, 2016

First Posted

March 9, 2016

Study Start

July 1, 2012

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

March 9, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations