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Motor Learning for the Lumbar Spine Using Sensor-based Postural Feedback: a Randomized Controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02773160
Recruitment Status : Unknown
Verified May 2016 by Annick Timmermans, Hasselt University.
Recruitment status was:  Recruiting
First Posted : May 16, 2016
Last Update Posted : May 16, 2016
Sponsor:
Collaborator:
Jessa Hospital
Information provided by (Responsible Party):
Annick Timmermans, Hasselt University

Brief Summary:
A large subgroup of patients with chronic non-specific low back pain have motor control impairments. During motor control exercises, different forms of external feedback can be used to support training. This randomized controlled trial will investigate the effectiveness of different forms of external feedback during the learning phase of a motor control task for the lumbar spine in healthy subjects and patients with chronic non-specific low back pain (CNSLBP). Both healthy subjects and patients with CNSLBP will be randomized into three groups: one group will receive feedback from motion sensors, one group from a mirror and one group will receive no feedback (control group). A single session intervention with measurements at baseline and immediately post-intervention will be used.

Condition or disease Intervention/treatment Phase
Chronic Non-specific Low Back Pain Other: Sensor-based postural feedback Other: Mirror feedback Other: Control group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Motor Learning for the Lumbar Spine Using Sensor-based Postural Feedback: a Randomized Controlled Trial
Study Start Date : April 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Sensor-based postural feedback
Subjects will receive visual feedback on a computer screen while practicing the motor control task. The feedback is based on information from from motion sensors that mointor the movements of the lumbar spine
Other: Sensor-based postural feedback
Motion tracking sensors will provide feedback to subjects during the learning phase of a motor control task

Experimental: Mirror Feedback
Subjects will receive feedback from a mirror while practicing the motor control task
Other: Mirror feedback
Subjects will receive feedback from a mirror during the learning phase of a motor control task

Active Comparator: control group
Subjects will receive no feedback while practicing the motor control task
Other: Control group
Subjects will receive no feedback during the learning phase of a motor control task




Primary Outcome Measures :
  1. Change in lumbopelvic kinematics from baseline to immediately post-intervention [ Time Frame: Day 1, immediately post-intervention ]
    Kinematics will be assessed using motion sensors that are mounted on the skin at the spinous processes of L1 and S1, and at the femur.


Secondary Outcome Measures :
  1. usefulness of feedback (Numeric rating scale 0-10) [ Time Frame: Day 1, immediately post-intervention ]
    How useful was the feedback that was provided to the subjects during the exercise trials?

  2. Pain during the exercise trials (Numeric rating scale 0-10) [ Time Frame: Day 1, immediately post-intervention ]
    Outcome measure primarily used as possible covariate

  3. Fear of low back pain during the exercise trials (Numeric rating scale 0-10) [ Time Frame: Day 1, immediately post-intervention ]
    Outcome measure primarily used as possible covariate

  4. Fear of damaging the lumbar spine during the exercise trials (numeric rating scale 0-10) [ Time Frame: Day 1, immediately post-intervention ]
    Outcome measure primarily used as possible covariate

  5. Borg-scale to measure fatigue during the exercise trials [ Time Frame: Day 1, immediately post-intervention ]
    Outcome measure primarily used as possible covariate



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Chronic non-specific low back pain
  • Age 18-65
  • Able to understand Dutch

Exclusion Criteria:

  • Subjects that received lumbar stabilization exercises in the past year
  • Spinal surgery in the past
  • Pregnancy
  • Serious underlying pathologies (e.g. multiple sclerosis, tumors,…)
  • Signs or symptoms of nerve root involvement
  • Any physical condition at the moment of testing that can interfere with activities of daily living (e.g. serious knee pain)
  • Known skin-allergy for tape
  • BMI > 30kg/m²

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773160


Contacts
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Contact: Thomas Matheve, drs. Thomas.Matheve@UHasselt.be
Contact: Annick Timmermans, prof. dr. Annick.Timmermans@uhasselt.be

Locations
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Belgium
Universiteit Hasselt Recruiting
Diepenbeek, Belgium, 3590
Contact: thomas Matheve, drs.         
Principal Investigator: Martine Timmermans, prof. dr.         
Jessa Ziekenhuis Recruiting
Hasselt, Belgium, 3500
Contact: Thomas Matheve, drs.         
Sub-Investigator: Enzo Olivieri, dr.         
Sponsors and Collaborators
Hasselt University
Jessa Hospital
Investigators
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Principal Investigator: Annick Timmermans, prof. dr. Hasselt University
Study Chair: Enzo Olivieri, dr. Jessa Ziekenhuis, Hasselt, Belgium
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Annick Timmermans, prof. dr., Hasselt University
ClinicalTrials.gov Identifier: NCT02773160    
Other Study ID Numbers: AcuteLearningEffects
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: May 16, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Low Back Pain
Back Pain
Pain
Neurologic Manifestations