Chronic Low-back PainNCT05851118
Locomotion Strategies of Low Back Pain Patients in a Dynamic Environment
An observational study of Chronic Low-back Pain and Walking, run by University of Rennes 2 at 1 site in France.
Trial summary
The biomechanical parameters studied in non-specific chronic low back pain patients in a locomotion task have so far focused on straight line walking. Although locomotion is primarily an automated action composed of repetitive patterns allowing movement from one place to another, walkers must respond to the… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Low-back Pain, Walking
- What is being tested?
- Quantified analysis of walking during a crossing task between two walkers
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2023to 1 May 2024
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with non-specific low back pain are recruited as part of their medical follow-up in a medical centre in France.
Who may be able to join
- Participants strictly meet the same inclusion and non-inclusion criteria as NSCLBP patients, but must not have ongoing chronic pain or a history of significant chronic pain (≥ 4/10 for at least 6 months). They are matched for age and gender. They must not have any pathologies that affect walking or posture. These individuals must be able to perform the studied movements without the appearance of discomfort or exaggerated fatigue.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Anne-Hélène Olivier, PhD contact
France1 site, 1 recruiting
- Recruiting
University of Rennes 2
Rennes, 35000
Agathe Bilhaut, PhD student, +33 (0) 632030985, agathe.bilhaut@univ-rennes2.fr
Anne-Hélène Olivier, PhD, anne-helene.olivier@univ-rennes2.fr
About this study
Official title: Collision Avoidance Behavior Between Walkers: Locomotion Strategies of Patients With Chronic Non-Specific Low Back Pain
The biomechanical parameters studied in non-specific chronic low back pain patients in a locomotion task have so far focused on straight line walking. Although locomotion is primarily an automated action composed of repetitive patterns allowing movement from one place to another, walkers must respond to the environmental demands.These modifications show a flexible and adaptive approach to the constraints of the environment. In this study, the investigators are particularly interested in a task of crossing between two pedestrians, which is a standardised task that has shown its interest in the study of perceptual-motor co-ordination. In particular, it allows to study the mutual adaptation of speed and orientation between the two walkers.
- Conditions
- Chronic Low-back Pain, Walking
- Being tested
- Quantified analysis of walking during a crossing task between two walkers
- Keywords
- Low Back Pain, Psychomotor Performance / physiology, Walking / physiology*, Adult, Humans, Motion Perception / physiology*
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantified analysis of walking during a crossing task between two walkersBehavioural
Functional test that reproduce a task of daily living.
| Study group | Role | What they receive |
|---|---|---|
| Non-Specific Low Back Pain patients | Participants must have pain located between the thoracolumbar hinge and the lower gluteal fold, with or without pain in either leg, present for more than 12 weeks, on a daily or almost daily basis (at least 4 days out of 7). Receives: Behavioral: Quantified analysis of walking during a crossing task between two walkers | |
| Control group | Participant with no current or past chronic pain Receives: Behavioral: Quantified analysis of walking during a crossing task between two walkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Threshold for motion adaptation
Thresholds of adaptation to movement will be identified by comparing the minimum crossing distance and the minimum predicted distance of crossing at the time the walkers first see each other.
Measured: Clinical assessment at base line
Secondary outcomes (4)
Walking speed
Analysis of the walking speed of each walker for the control tests, i.e. where the walker has not encountered another walker.
Measured: Clinical assessment at base line
Inversion of crossing order
mpd(t) was assigned according to the final crossing order between two walkers in such a way that allowed for a positive mpd (tcross). In doing so, a positive mpd(tsee) suggests that crossing order was preserved along the entire interaction. Alternatively, a negative mpd (tsee) is the result of an inversion in crossing order between the two walkers.
Measured: Clinical assessment at base line
Contribution to collision avoidance
During the interaction period, a cumulative contribution must be made by both walkers to avoid a collision. Analysis of the contribution of each walker (speed and orientation).
Measured: Clinical assessment at base line
Minimum Predicted Distance
Minimum Predicted Distance (mpd) represents the theoretical crossing distance between the future positions of the participants, based on a linear extrapolation of their trajectory given their current position and speed at time (t). Any variation in mpd(t) indicates that a movement adaptation to avoid a collision has taken place between two walkers.
Measured: Clinical assessment at base line
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start1 Mar 2023
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rennes 2
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agathe Bilhaut, University of Rennes 2
- Investigators
- Olivier Roze, Principal investigator, Clinique de la Sagesse, Rennes, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851118
- Sponsor's protocol ID
- PERL2
- Status last verified
- May 2023
- First submitted
- 28 Apr 2023
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collision Avoidance Behavior Between Walkers: Locomotion Strategies of Patients With Chronic Non-Specific Low Back Pain
- ClinicalTrials.gov ID
- NCT05851118
- Acronym / sponsor ID
- PERL2
- Conditions
- Chronic Low-back Pain, Walking
- Keywords
- Low Back Pain, Psychomotor Performance / physiology, Walking / physiology*, Adult, Humans, Motion Perception / physiology*
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of Rennes 2University, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 9 May 2023 (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.
The biomechanical parameters studied in non-specific chronic low back pain patients in a locomotion task have so far focused on straight line walking. Although locomotion is primarily an automated action composed of repetitive patterns allowing movement from one place to another, walkers must respond to the environmental demands.These modifications show a flexible and adaptive approach to the constraints of the environment. In this study, the investigators are particularly interested in a task of crossing between two pedestrians, which is a standardised task that has shown its interest in the study of perceptual-motor co-ordination. In particular, it allows to study the mutual adaptation of speed and orientation between the two walkers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Specific Low Back Pain patients | – | Behavioral: Quantified analysis of walking during a crossing task between two walkersParticipants must have pain located between the thoracolumbar hinge and the lower gluteal fold, with or without pain in either leg, present for more than 12 weeks, on a daily or almost daily basis (at least 4 days out of 7). |
| Control group | – | Behavioral: Quantified analysis of walking during a crossing task between two walkersParticipant with no current or past chronic pain |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with non-specific low back pain are recruited as part of their medical follow-up in a medical centre in France.
Key inclusion criteria (1 listed)
- Participants strictly meet the same inclusion and non-inclusion criteria as NSCLBP patients, but must not have ongoing chronic pain or a history of significant chronic pain (≥ 4/10 for at least 6 months). They are matched for age and gender. They must not have any pathologies that affect walking or posture. These individuals must be able to perform the studied movements without the appearance of discomfort or exaggerated fatigue.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Quantified analysis of walking during a crossing task between two walkersFunctional test that reproduce a task of daily living. | Behavioural | Control group, Non-Specific Low Back Pain patients |
Primary outcome
Threshold for motion adaptation
Time frame: Clinical assessment at base line
Thresholds of adaptation to movement will be identified by comparing the minimum crossing distance and the minimum predicted distance of crossing at the time the walkers first see each other.
4 secondary outcomes
Walking speed
Time frame: Clinical assessment at base line
Inversion of crossing order
Time frame: Clinical assessment at base line
Contribution to collision avoidance
Time frame: Clinical assessment at base line
Minimum Predicted Distance
Time frame: Clinical assessment at base line
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
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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.
Anne-Hélène Olivier, PhD contact
Olivier Roze principal investigator
Clinique de la Sagesse, Rennes, France
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 and Walking, run by University of Rennes 2 at 1 site in France.
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 1 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 11 May 2023. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Agathe Bilhaut, PhD student (+33 (0) 632030985, agathe.bilhaut@univ-rennes2.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Threshold for motion adaptation (time frame: Clinical assessment at base line). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2023.