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

Chronic Low-back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04588155
• Other study ID #: TUGLBP_FDG
• Status: Completed
• Start date: December 9, 2019
• Est. completion date: January 30, 2020

Study information

• Verified date: October 2020
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 30, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

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

Locations

Country	Name	City	State
Italy	Fondazione Don Carlo Gnocchi Onlus - Centro Ettore Spalenza	Rovato	Brescia

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Temporal parameters of movement	Temporal analysis of TUG performance	through study completion, an average of 2 month
Primary	Kinematic parameters of movement	Kinematic analysis of TUG performance	through study completion, an average of 2 month
Secondary	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
Secondary	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