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

Completed

• Conditions: Chronic Low-back Pain
• Interventions: Device: Functional assessment; Other: Clinical assessment

• Registration Number: NCT04588155
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-09
• Primary Completion: 2020-01-30
• Study Completion: 2020-01-30
• Study First Submitted: 2020-09-17
• Status Verified: 2020-10
• Study First Submitted QC: 2020-10-08
• Last Update Submitted: 2020-10-08
• Study First Posted: 2020-10-19
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic Low-Back Pain	Functional assessment	Subjects diagnosed with Chronic Low-Back Pain in rehabilitation program: functional assessment (with temporal and kinematic analysis) and clinical assessment.
Chronic Low-Back Pain	Clinical assessment	Subjects diagnosed with Chronic Low-Back Pain in rehabilitation program: functional assessment (with temporal and kinematic analysis) and clinical assessment.
Healthy	Functional assessment	Healthy subjects: functional assessment (with temporal and kinematic analysis)

Primary Outcome Measures

Name	Time	Method
Temporal parameters of movement	through study completion, an average of 2 month	Temporal analysis of TUG performance
Kinematic parameters of movement	through study completion, an average of 2 month	Kinematic analysis of TUG performance

Secondary Outcome Measures

Name	Time	Method
Numerical Pain Rating Scale	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.
Roland Morris Disability Questionnaire	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).

Trial Locations

Locations (1)

Fondazione Don Carlo Gnocchi Onlus - Centro Ettore Spalenza; 🇮🇹 Rovato, Brescia, Italy