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Completed

NCT Number: NCT03841552

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

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zurich University of Applied Sciences

Winterthur, Canton of Zurich, 8400, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Augmented Feedback

Device

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.

Control Group

Other

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 outcomes

  1. Change from Baseline ratio of the range of motion (ROM) of the stabilized lumbar spine (ROMLS) over the moving body segment, the hip (ROMHip)

    Time frame: From Baseline to the completion of nine physiotherapy sessions, which are completed after a maximum of five weeks (Swiss standard prescription)

    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)

  2. Changes from Baseline of the mean absolute deviation of lumbar agular displacement

    Time frame: From Baseline to the completion of nine physiotherapy sessions, which are completed after a maximum of five weeks (Swiss standard prescription)

    Postural control was quantified using the mean absolute deviation of lumbar angular displacement (MAD)

Sponsors and collaborators

Lead sponsor

Zurich University of Applied Sciences

Other

Collaborators

  • Danube University Krems
  • MedBase Brunngasse Winterthur

Registry information

Official study title

Efficacy of Augmented Feedback on Lumbar Postural and Movement Control During Physiotherapy and Home Exercise - A Randomized Controlled Pilot Trial

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 15, 2019
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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