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

NCT04588155 | Completed

• 1 other identifier: TUGLBP_FDG
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Low-back Pain

Keywords

Chronic Low-back Pain; Functional assessment; Time Up and Go Test; Inertial measurement unit

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Roland Morris Disability Questionnaire

  through study completion, an average of 2 month

• Numerical Pain Rating Scale

  through study completion, an average of 2 month

Study Arms (2)

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; Other: Clinical assessment

Healthy

Healthy subjects: functional assessment (with temporal and kinematic analysis)

Device: Functional assessment

Interventions

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

Chronic Low-Back Pain; Healthy

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

Chronic Low-Back Pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

Fondazione Don Carlo Gnocchi Onlus - Centro Ettore Spalenza

Rovato, Brescia, 25038, Italy

Location

Related Publications (1)

• Buraschi R, Pollet J, Villafane JH, Piovanelli B, Negrini S. Temporal and kinematic analyses of timed up and go test in chronic low back pain patients. Gait Posture. 2022 Jul;96:137-142. doi: 10.1016/j.gaitpost.2022.05.027. Epub 2022 May 26.

  PMID: 35635989 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: October 19, 2020
• Study Start: December 9, 2019
• Primary Completion: January 30, 2020
• Study Completion: January 30, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Locations

IT (1)