NCT02007135

Brief Summary

The purpose of this study is to determine the concurrent validity of a newly developed pneumatic, fMRI compatible muscle vibrator as compared to a electromagnetic muscle vibrator in the stimulation of muscle proprioceptors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2013

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

November 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 5, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 10, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 16, 2015

Status Verified

October 1, 2015

Enrollment Period

1 year

First QC Date

December 5, 2013

Last Update Submit

October 14, 2015

Conditions

Proprioceptive Postural Control

Outcome Measures

Primary Outcomes (1)

  • Proprioceptive postural control

    Center of pressure displacement on a force plate in standing in response to local muscle vibration on ankle and back muscles to specifically detect the role of proprioception in postural control.

    6 months

Study Arms (1)

Healthy

Healthy persons, without non-specific low back pain

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Young Flemish Volunteers

You may qualify if:

  • Age: 20-45 years old
  • No history of low back pain
  • A score of 0% on the Oswestry Disability Index
  • Willingness to sign the informed consent

You may not qualify if:

  • History of major trauma and/or major orthopedic surgery of the spine, pelvis or lower quadrant
  • One of the following conditions: Parkinson, MS, Stroke with sequels....
  • Radicular symptoms
  • Not Dutch-speaking
  • Strong opioids
  • Neck pain
  • Ankle problems
  • Smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Katholieke Universiteit Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

  • Claeys K, Brumagne S, Dankaerts W, Kiers H, Janssens L. Decreased variability in postural control strategies in young people with non-specific low back pain is associated with altered proprioceptive reweighting. Eur J Appl Physiol. 2011 Jan;111(1):115-23. doi: 10.1007/s00421-010-1637-x. Epub 2010 Sep 8.

    PMID: 20824281BACKGROUND

Study Officials

  • Simon Brumagne, Professor

    KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Simon Brumagne

Study Record Dates

First Submitted

December 5, 2013

First Posted

December 10, 2013

Study Start

November 1, 2013

Primary Completion

November 1, 2014

Study Completion

October 1, 2015

Last Updated

October 16, 2015

Record last verified: 2015-10

Locations

BE(1)