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NCT Number: NCT04588155

Temporal and Kinematic Analysis of Timed Up and Go Test in Chronic Low Back Pain Patients

Kinematic and temporal analysis of the movement helps researchers and clinicians to better understand the way humans move and interact within the environment in which they live, better describe the alterations coming from impairments, and finally allow to better tailor interventions for patients. In this perspective, motion analysis has become, in the last 30 years, a remarkable and important field of research. Even if movement assessment should be a cornerstone for definition and modulation of rehabilitation interventions, there are still few motion analysis devices that are able to influence the clinical decision process; motion analysis labs are among those, but their use is unfortunately limited due to the costs of instruments and analysis. Other small unobtrusive wearable devices, easier to use and cost-effective, have been developed, like Inertial measurement units (IMU), composed by accelerometers and gyroscopes. They could therefore represent an incentive for a more widespread use of motion analysis within daily clinical activity in Rehabilitaion.

Timed Up and Go Test (TUG) is a simple, widely used, functional test which involves standing up from a chair, walking three meters, turning, and going back to sit. It is used to evaluate movement, mobility, dynamic and static balance in people with musculoskeletal impairment, neurological diseases, aging related conditions, and the quality of life in people with low back pain. The only and easy outcome considered is the time to completion. Nevertheless, the application of an IMU to a subject performing TUG can provide other objective, quantitative data, like temporal and kinematic parameters of the whole test and its sub-phases. The instrumented TUG (iTUG) has already been applied, mainly in the neurorehabilitation field, in particular for Parkinson's disease and for post-stroke impairments.

cLBP is one of the most burdensome health problem worldwide. cLBP has been considered a bio-psycho-social disease, characterized by pain in the lumbar region, functional impairments, and condition-related disability. Despite the obvious motor problems affecting people with cLBP, to the best of our knowledge, chronic low back pain (cLBP) has not yet been explored using iTUG.

The aim of study is to analyse temporal and kinematic parameters of cLBP subjects compared to BMI and age-matched healthy subjects, through iTUG and to explore the correlations of those parameters with pain and disability.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Don Carlo Gnocchi Onlus - Centro Ettore Spalenza

Rovato, Brescia, 25038, Italy

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

(for Chronic Low Back Pain population):

  • Pain from at least 3 months
  • Numerical Pain Rating Scale (NPRS) ≥ 4

Exclusion criteria

(for Chronic Low Back Pain population):

  • History of neurological impairment or disease,
  • Other orthopaedic impairment within the past 6 months or surgery in the previous 6 months.

Treatment and study plan

Functional assessment

Device

Timed Up and Go Test administration with application of Inertial Measurement Unit for a temporal and kinematic assessment of movement performed during test esecution

Clinical Assessment

Other

Roland Morris Disability Questionnaire (RMDQ) to assess the level of functional impairment and disability in the activity of daily living

Numerical Pain Rating System (NPRS) administration to quantify level of pain experienced just before the TUG test execution

Primary outcomes

  1. Temporal parameters of movement

    Time frame: through study completion, an average of 2 month

    Temporal analysis of TUG performance

  2. Kinematic parameters of movement

    Time frame: through study completion, an average of 2 month

    Kinematic analysis of TUG performance

Secondary outcomes

  1. Roland Morris Disability Questionnaire

    Time frame: through study completion, an average of 2 month

    Questionnaire that assess levels of impairment and disability coming from low back pain The score can range from 0 (no disability) to 24 (severe disability).

  2. Numerical Pain Rating Scale

    Time frame: through study completion, an average of 2 month

    Scale for pain assessment: the minimum value "0" and maximum values "10", where higher scores mean a worse outcome.

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Registry information

Official study title

Temporal and Kinematic Analysis of Timed Up and Go Test in Chronic Low Back Pain

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 19, 2020
Registry last updated
Oct 19, 2020

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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