Chronic Low-back PainNCT04588155
Temporal and Kinematic Analysis of Timed Up and Go Test in Chronic Low Back Pain Patients
An observational study of Chronic Low-back Pain, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Functional assessment and Clinical assessment
- Type of treatment
- Medical device
- How many people
- 44 participants
- Where
- 1 siteItaly
- Study dates
- 9 Dec 2019to 30 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Pain from at least 3 months
- Numerical Pain Rating Scale (NPRS) ≥ 4
Who cannot join
- History of neurological impairment or disease,
- Other orthopaedic impairment within the past 6 months or surgery in the previous 6 months.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Don Carlo Gnocchi Onlus - Centro Ettore Spalenza
Rovato, Brescia, 25038
About this study
Official title: 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.
Read more
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
- Being tested
- Functional assessment, Clinical assessment
- Keywords
- Chronic Low-back Pain, Functional assessment, Time Up and Go Test, Inertial measurement unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional assessmentDevice
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 assessmentOther
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
| Study group | Role | What they receive |
|---|---|---|
| Chronic Low-Back Pain | Subjects diagnosed with Chronic Low-Back Pain in rehabilitation program: functional assessment (with temporal and kinematic analysis) and clinical assessment. Receives: Device: Functional assessment; Other: Clinical assessment | |
| Healthy | Healthy subjects: functional assessment (with temporal and kinematic analysis) Receives: Device: Functional assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temporal parameters of movement
Temporal analysis of TUG performance
Measured: through study completion, an average of 2 month
Kinematic parameters of movement
Kinematic analysis of TUG performance
Measured: through study completion, an average of 2 month
Secondary outcomes (2)
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).
Measured: 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.
Measured: through study completion, an average of 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start9 Dec 2019
- Primary completion30 Jan 2020
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riccardo Buraschi, Fondazione Don Carlo Gnocchi ETS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04588155
- Sponsor's protocol ID
- TUGLBP_FDG
- Status last verified
- Oct 2020
- First submitted
- 17 Sep 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35635989
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporal and Kinematic Analysis of Timed Up and Go Test in Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT04588155
- Acronym / sponsor ID
- TUGLBP_FDG
- Conditions
- Chronic Low-back Pain
- Keywords
- Chronic Low-back Pain, Functional assessment, Time Up and Go Test, Inertial measurement unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Low-Back Pain | – | Device: Functional assessment, Other: Clinical assessmentSubjects diagnosed with Chronic Low-Back Pain in rehabilitation program: functional assessment (with temporal and kinematic analysis) and clinical assessment. |
| Healthy | – | Device: Functional assessmentHealthy subjects: functional assessment (with temporal and kinematic analysis) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Pain from at least 3 months
- Numerical Pain Rating Scale (NPRS) ≥ 4
Key exclusion criteria (2 listed)
- History of neurological impairment or disease,
- Other orthopaedic impairment within the past 6 months or surgery in the previous 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional assessmentTimed Up and Go Test administration with application of Inertial Measurement Unit for a temporal and kinematic assessment of movement performed during test esecution | Device | Chronic Low-Back Pain, Healthy |
| Clinical assessmentRoland 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 | Other | Chronic Low-Back Pain |
Primary outcome
Temporal parameters of movement
Time frame: through study completion, an average of 2 month
Temporal analysis of TUG performance
Kinematic parameters of movement
Time frame: through study completion, an average of 2 month
Kinematic analysis of TUG performance
2 secondary outcomes
Roland Morris Disability Questionnaire
Time frame: through study completion, an average of 2 month
Numerical Pain Rating Scale
Time frame: through study completion, an average of 2 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Derived from this study: PubMed 35635989Buraschi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Low-back Pain, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temporal parameters of movement (time frame: through study completion, an average of 2 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04588155, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.