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Efficacy of Augmented Feedback on Lumbar Postural and Movement Control During Physiotherapy and Home Exercise

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Augmented Feedback
Control Group
Sponsored by
Zurich University of Applied Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low Back Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • non specific low back pain for at least four weeks
  • at least moderate disability (as indicated by an Oswestry disability index (ODI) > 8% (Mannion et al., 2006))
  • low levels of biopsychosocial risk factors (STarT Back Screening tool > 4 points) (Hill et al., 2011)
  • at least two positive movement control impairment tests (Luomajoki et al., 2008, Sahrmann, 2002)

Exclusion Criteria:

  • specific low back pain
  • pain in other areas of the body (e.g. neck, head, thoracic spine or arms)
  • vertigo or equilibrium disturbances
  • systemic diseases (e.g. tumours and diabetes)
  • injuries
  • surgeries of the legs within the last six months
  • medication affecting postural control
  • pregnancy

Sites / Locations

  • Zurich University of Applied Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Augmented Feedback

Control Group

Arm Description

The exercises were conducted with the aim of improving postural- and movement control and awareness of the lumbar spine in both treatment groups. Both groups received nine 30-minute therapy sessions, during which they performed a series of exercises from an exercise catalogue. The exercises were selected based on their compatibility with the AF-system. Each patient performed impairment-specific exercises. The AF group received additional AF feedback during both the therapy sessions and the home exercise program, by combining the exercises with games designed to target movement control, body awareness, and stabilisation exercises.

The control group performed the impairment-specific exercises without AF. The control group was able to receive conventional visual feedback, such as use of mirrors, as deemed appropriate by the therapists but no AF.

Outcomes

Primary Outcome Measures

Change from Baseline ratio of the range of motion (ROM) of the stabilized lumbar spine (ROMLS) over the moving body segment, the hip (ROMHip)
Movement control was quantified using the ratio of the range of motion (ROM) of the stabilized lumbar spine (ROMLS) over the moving body segment, the hip (ROMHip) during the movement control test (lumbar spine (LS) over the hip)
Changes from Baseline of the mean absolute deviation of lumbar agular displacement
Postural control was quantified using the mean absolute deviation of lumbar angular displacement (MAD)

Secondary Outcome Measures

Full Information

First Posted
February 5, 2019
Last Updated
February 13, 2019
Sponsor
Zurich University of Applied Sciences
Collaborators
Danube University Krems, MedBase Brunngasse Winterthur
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1. Study Identification

Unique Protocol Identification Number
NCT03841552
Brief Title
Efficacy of Augmented Feedback on Lumbar Postural and Movement Control During Physiotherapy and Home Exercise
Official Title
Efficacy of Augmented Feedback on Lumbar Postural and Movement Control During Physiotherapy and Home Exercise - A Randomized Controlled Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2012 (Actual)
Primary Completion Date
April 30, 2013 (Actual)
Study Completion Date
April 30, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zurich University of Applied Sciences
Collaborators
Danube University Krems, MedBase Brunngasse Winterthur

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Exercise therapy is effective in improving pain experience and disability in patients with non-specific low back pain (NSLBP) and movement/postural control impairments. However, patients often find traditional exercises monotonous and discontinue their execution. Augmented feedback tools (AF) might improve patient adherence and therapy outcomes, but evidence is currently lacking on their effects on movement/postural control. In a pilot randomised controlled trial (RCT) on a population of patients with NSLBP and movement control impairment, treatment with physiotherapy and home exercise supported by AF is compared to traditional physiotherapy and home exercise treatment without AF (control group). The primary outcomes are defined as lumbar movement control and postural control, measured using an inertial measurement system.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled pilot trial
Masking
InvestigatorOutcomes Assessor
Masking Description
The investigators who collected the outcome data, as well as the statistician were blinded to group allocation.
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Augmented Feedback
Arm Type
Experimental
Arm Description
The exercises were conducted with the aim of improving postural- and movement control and awareness of the lumbar spine in both treatment groups. Both groups received nine 30-minute therapy sessions, during which they performed a series of exercises from an exercise catalogue. The exercises were selected based on their compatibility with the AF-system. Each patient performed impairment-specific exercises. The AF group received additional AF feedback during both the therapy sessions and the home exercise program, by combining the exercises with games designed to target movement control, body awareness, and stabilisation exercises.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
The control group performed the impairment-specific exercises without AF. The control group was able to receive conventional visual feedback, such as use of mirrors, as deemed appropriate by the therapists but no AF.
Intervention Type
Device
Intervention Name(s)
Augmented Feedback
Intervention Description
An inertial measurement unit (IMU) system is the basis of the augmented feedback (AF) system, where the IMU-system communicates with a laptop using a bluetooth dongle. The corresponding software includes therapeutic games. Movements of the lower back and pelvis by the patient are used to control an avatars movement or the graphical interface in computer exercises. The AF-system provides real-time feedback regarding the patient's performance and helps to rectify incorrect execution of the exercises. The intervention took place at a physiotherapy clinic and in an home environment. In the physiotherapy clinic the patients exercised under the supervision of the physiotherapists. They continued the exercises at home as home exercises.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
Conventional impairment-specific physiotherapy exercises for low back pain patients.The control intervention took place at a physiotherapy clinic and in an home environment. In the physiotherapy clinic the patients exercised under the supervision of the physiotherapists. They continued the exercises at home as home exercises.
Primary Outcome Measure Information:
Title
Change from Baseline ratio of the range of motion (ROM) of the stabilized lumbar spine (ROMLS) over the moving body segment, the hip (ROMHip)
Description
Movement control was quantified using the ratio of the range of motion (ROM) of the stabilized lumbar spine (ROMLS) over the moving body segment, the hip (ROMHip) during the movement control test (lumbar spine (LS) over the hip)
Time Frame
From Baseline to the completion of nine physiotherapy sessions, which are completed after a maximum of five weeks (Swiss standard prescription)
Title
Changes from Baseline of the mean absolute deviation of lumbar agular displacement
Description
Postural control was quantified using the mean absolute deviation of lumbar angular displacement (MAD)
Time Frame
From Baseline to the completion of nine physiotherapy sessions, which are completed after a maximum of five weeks (Swiss standard prescription)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: non specific low back pain for at least four weeks at least moderate disability (as indicated by an Oswestry disability index (ODI) > 8% (Mannion et al., 2006)) low levels of biopsychosocial risk factors (STarT Back Screening tool > 4 points) (Hill et al., 2011) at least two positive movement control impairment tests (Luomajoki et al., 2008, Sahrmann, 2002) Exclusion Criteria: specific low back pain pain in other areas of the body (e.g. neck, head, thoracic spine or arms) vertigo or equilibrium disturbances systemic diseases (e.g. tumours and diabetes) injuries surgeries of the legs within the last six months medication affecting postural control pregnancy
Facility Information:
Facility Name
Zurich University of Applied Sciences
City
Winterthur
State/Province
Zurich
ZIP/Postal Code
8400
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25603757
Citation
Hugli AS, Ernst MJ, Kool J, Rast FM, Rausch-Osthoff AK, Mannig A, Oetiker S, Bauer CM. Adherence to home exercises in non-specific low back pain. A randomised controlled pilot trial. J Bodyw Mov Ther. 2015 Jan;19(1):177-85. doi: 10.1016/j.jbmt.2014.11.017. Epub 2014 Nov 27.
Results Reference
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Efficacy of Augmented Feedback on Lumbar Postural and Movement Control During Physiotherapy and Home Exercise

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