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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Low-back Pain
• Intervention / Treatment: Device: Functional assessment; Other: Clinical assessment

• Study Type: Observational
• Enrollment (Actual): 44

Contacts and Locations

Study Locations

• Italy
  • Brescia
    • Rovato, Brescia, Italy, 25038
      • Fondazione Don Carlo Gnocchi Onlus - Centro Ettore Spalenza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Population of Chronic Low Back Pain subjects participating to an outpatient rehabilitation program; Population of healthy subjects, age and BMI-matched with the Low Back Pian sample.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chronic Low-Back Pain; Subjects diagnosed with Chronic Low-Back Pain in rehabilitation program: functional assessment (with temporal and kinematic analysis) and clinical assessment.	Device: Functional assessment; Timed Up and Go Test administration with application of Inertial Measurement Unit for a temporal and kinematic assessment of movement performed during test esecution; Other: Clinical assessment; 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
Healthy; Healthy subjects: functional assessment (with temporal and kinematic analysis)	Device: Functional assessment; Timed Up and Go Test administration with application of Inertial Measurement Unit for a temporal and kinematic assessment of movement performed during test esecution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Temporal parameters of movement	Temporal analysis of TUG performance	through study completion, an average of 2 month
Kinematic parameters of movement	Kinematic analysis of TUG performance	through study completion, an average of 2 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Roland Morris Disability Questionnaire	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).	through study completion, an average of 2 month
Numerical Pain Rating Scale	Scale for pain assessment: the minimum value "0" and maximum values "10", where higher scores mean a worse outcome.	through study completion, an average of 2 month

Collaborators and Investigators

• Sponsor: Fondazione Don Carlo Gnocchi Onlus

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2019
• Primary Completion (Actual): January 30, 2020
• Study Completion (Actual): January 30, 2020

Study Registration Dates

• First Submitted: September 17, 2020
• First Submitted That Met QC Criteria: October 8, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 8, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Functional assessment; Chronic Low-back Pain; Time Up and Go Test; Inertial measurement unit
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: TUGLBP_FDG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No