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

Primary Purpose

Chronic Non-specific Low Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Sensor-based postural feedback
Mirror feedback
Control group
Sponsored by
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Non-specific Low Back Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Universiteit HasseltRecruiting
  • Jessa ZiekenhuisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Sensor-based postural feedback

Mirror Feedback

control group

Arm Description

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

Subjects will receive feedback from a mirror while practicing the motor control task

Subjects will receive no feedback while practicing the motor control task

Outcomes

Primary Outcome Measures

Change in lumbopelvic kinematics from baseline to 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

usefulness of feedback (Numeric rating scale 0-10)
How useful was the feedback that was provided to the subjects during the exercise trials?
Pain during the exercise trials (Numeric rating scale 0-10)
Outcome measure primarily used as possible covariate
Fear of low back pain during the exercise trials (Numeric rating scale 0-10)
Outcome measure primarily used as possible covariate
Fear of damaging the lumbar spine during the exercise trials (numeric rating scale 0-10)
Outcome measure primarily used as possible covariate
Borg-scale to measure fatigue during the exercise trials
Outcome measure primarily used as possible covariate

Full Information

First Posted
January 11, 2016
Last Updated
May 13, 2016
Sponsor
Hasselt University
Collaborators
Jessa Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02773160
Brief Title
Motor Learning for the Lumbar Spine Using Sensor-based Postural Feedback: a Randomized Controlled Trial
Official Title
Motor Learning for the Lumbar Spine Using Sensor-based Postural Feedback: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
Jessa Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Non-specific Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sensor-based postural feedback
Arm Type
Experimental
Arm Description
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
Arm Title
Mirror Feedback
Arm Type
Experimental
Arm Description
Subjects will receive feedback from a mirror while practicing the motor control task
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Subjects will receive no feedback while practicing the motor control task
Intervention Type
Other
Intervention Name(s)
Sensor-based postural feedback
Intervention Description
Motion tracking sensors will provide feedback to subjects during the learning phase of a motor control task
Intervention Type
Other
Intervention Name(s)
Mirror feedback
Intervention Description
Subjects will receive feedback from a mirror during the learning phase of a motor control task
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
Subjects will receive no feedback during the learning phase of a motor control task
Primary Outcome Measure Information:
Title
Change in lumbopelvic kinematics from baseline to immediately post-intervention
Description
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.
Time Frame
Day 1, immediately post-intervention
Secondary Outcome Measure Information:
Title
usefulness of feedback (Numeric rating scale 0-10)
Description
How useful was the feedback that was provided to the subjects during the exercise trials?
Time Frame
Day 1, immediately post-intervention
Title
Pain during the exercise trials (Numeric rating scale 0-10)
Description
Outcome measure primarily used as possible covariate
Time Frame
Day 1, immediately post-intervention
Title
Fear of low back pain during the exercise trials (Numeric rating scale 0-10)
Description
Outcome measure primarily used as possible covariate
Time Frame
Day 1, immediately post-intervention
Title
Fear of damaging the lumbar spine during the exercise trials (numeric rating scale 0-10)
Description
Outcome measure primarily used as possible covariate
Time Frame
Day 1, immediately post-intervention
Title
Borg-scale to measure fatigue during the exercise trials
Description
Outcome measure primarily used as possible covariate
Time Frame
Day 1, immediately post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Matheve, drs.
Email
Thomas.Matheve@UHasselt.be
First Name & Middle Initial & Last Name or Official Title & Degree
Annick Timmermans, prof. dr.
Email
Annick.Timmermans@uhasselt.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annick Timmermans, prof. dr.
Organizational Affiliation
Hasselt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Enzo Olivieri, dr.
Organizational Affiliation
Jessa Ziekenhuis, Hasselt, Belgium
Official's Role
Study Chair
Facility Information:
Facility Name
Universiteit Hasselt
City
Diepenbeek
ZIP/Postal Code
3590
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
thomas Matheve, drs.
First Name & Middle Initial & Last Name & Degree
Martine Timmermans, prof. dr.
Facility Name
Jessa Ziekenhuis
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Matheve, drs.
First Name & Middle Initial & Last Name & Degree
Enzo Olivieri, dr.

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30253807
Citation
Matheve T, Brumagne S, Demoulin C, Timmermans A. Sensor-based postural feedback is more effective than conventional feedback to improve lumbopelvic movement control in patients with chronic low back pain: a randomised controlled trial. J Neuroeng Rehabil. 2018 Sep 26;15(1):85. doi: 10.1186/s12984-018-0423-6.
Results Reference
derived

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

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