NCT05851118

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 9, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

1.2 years

First QC Date

April 28, 2023

Last Update Submit

May 9, 2023

Conditions

Chronic Low-back PainWalking

Keywords

Low Back PainPsychomotor Performance / physiologyWalking / physiology*AdultHumansMotion Perception / physiology*

Outcome Measures

Primary Outcomes (1)

  • 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.

    Clinical assessment at base line

Secondary Outcomes (4)

  • Walking speed

    Clinical assessment at base line

  • Inversion of crossing order

    Clinical assessment at base line

  • Contribution to collision avoidance

    Clinical assessment at base line

  • Minimum Predicted Distance

    Clinical assessment at base line

Other Outcomes (9)

  • Pain intensity

    Clinical assessment at base line

  • Temporal aspects of pain

    Clinical assessment at base line

  • Levels of anxiety and depression

    Clinical assessment at base line

  • +6 more other outcomes

Study Arms (2)

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).

Behavioral: Quantified analysis of walking during a crossing task between two walkers

Control group

Participant with no current or past chronic pain

Behavioral: Quantified analysis of walking during a crossing task between two walkers

Interventions

Quantified analysis of walking during a crossing task between two walkersBEHAVIORAL

Functional test that reproduce a task of daily living.

Control groupNon-Specific Low Back Pain patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with non-specific low back pain are recruited as part of their medical follow-up in a medical centre in France.

You may qualify if:

  • Participants must have pain located between the thoracolumbar hinge and the lower gluteal fold, with or without pain in either leg.
  • This pain must have been present for more than 12 weeks, on a daily or almost daily basis (at least 4 days out of 7)
  • Participants must speak, read and understand French
  • Participants must be between 18 and 65 years of age
  • Participants must be able to understand simple commands and experimental instructions
  • Participants must have normal or corrected vision
  • Participants must have given informed consent to participate in the study
  • Participants must be enrolled in or receiving social security benefits

You may not qualify if:

  • Participants must not be pregnant or nursing mothers.
  • Participants must not have cognitive or psychological impairments that are incompatible with compliance and/or understanding of the protocol
  • Participants must not be unable to understand informed consent, or be under guardianship or conservatorship Subjects must not already be participating in another research protocol involving the human subject or in parallel
  • Participants must not be persons deprived of liberty by judicial or administrative decision
  • Participants must not be under psychiatric care
  • The participants must not present neurological signs evoking a neurodegenerative disease responsible for walking disorders (parkinsonian syndrome, ...)
  • The participants must not present warning signs (red flags) pointing to an underlying pathology requiring specific and/or urgent care such as
  • Ongoing litigation following a work-related accident
  • Pain related to a cancer diagnosis
  • Associated spinal cord symptoms (pyramidal signs, coordination disorders, motor or sensory deficits, sphincter disorders, etc.)
  • Pain following an infection (night sweats, fever, chills, intravenous drug abuse, immunodeficiency, recent surgery, urinary or skin infection, etc.)
  • Recent or pathological fractures (traffic accidents, history of osteoporosis, chronic use of corticosteroids, advanced age, unexplained weight loss, fatigue, history of cancer, etc. )
  • Vascular problems (cold feet, decreased peripheral arterial pulse, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rennes 2

Rennes, 35000, France

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Olivier Roze

    Clinique de la Sagesse, Rennes, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Agathe Bilhaut, PhD student

CONTACT

+33 (0) 632030985agathe.bilhaut@univ-rennes2.fr

Anne-Hélène Olivier, PhD

CONTACT

anne-helene.olivier@univ-rennes2.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 28, 2023

First Posted

May 9, 2023

Study Start

March 1, 2023

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

May 11, 2023

Record last verified: 2023-05

Locations

FR(1)