NCT04795284

Brief Summary

The aim of this study is to compare biomechanical walking parameters between patients with symptomatic lumbar spinal stenosis and healthy elderly.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

September 9, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 12, 2021

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

4.3 years

First QC Date

March 8, 2021

Last Update Submit

March 24, 2025

Conditions

Keywords

Lumbar Spinal StenosisHealthy elderlyWalking capacityBiomechanical parameters

Outcome Measures

Primary Outcomes (3)

  • biomechanical walking parameters (gait cycle, stride length, walking time, walking speed, swing width, minimal toe clearance)

    Gait cycle = % stance phase, % swing phase / Stride length = describes the distance between two successive footprints on the ground / walking time = time to complete the 30-meters walking test in seconds / walking speed = walking stride velocity measured in meter/second / swing width = the maximal lateral excursion of the foot during the swing phase / minimal toe clearance = minimum height of the toes during the swing phase (in meter)

    During the 30-meter walking test

  • Quality of life (Euro-Qol - 5D)

    Quality of life related to mobility, self-care, usual activities, pain and discomfort, anxiety and depression. Each category has a score ranging from 1 to 3 and higher values indicate a worst outcome.

    One time (before the completion of the 30-meter walking test)

  • International Physical Activity Questionnaire (IPAQ)

    Physical activity habits. IPAQ score range from 1 to 3 where a score of 3 indicates a higher practice of physical activity

    One time (before the completion of the 30-meter walking test)

Secondary Outcomes (1)

  • French-Canadian adaptation of Swiss Spinal Stenosis Questionnaires (FC-SSSQ)

    One time (before the completion of the 30-meter walking test) - Only for patients with lumbar spinal stenosis

Study Arms (2)

Patients with symptomatic lumbar spinal stenosis

30-meter walking task (15 meters round trip) following by a rest period of 2 minutes. Participants are invited to perform the 30-meter walking task twice. Inertial sensors are put on each participant foot.

Healthy elderly

30-meter walking task (15 meters round trip) following by a rest period of 2 minutes. Participants are invited to perform the 30-meter walking task twice. Inertial sensors are put on each participant foot.

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Group 1: Patients with a symptomatic lumbar spinal stenosis Group 2: Healthy elderly from the community

You may qualify if:

  • Patients with lumbar spinal stenosis
  • Having a diagnosis of lumbar spinal stenosis (at least 1 level)
  • Having neurologic claudication due to the lumbar spinal stenosis
  • Healthy elderly
  • Being over 50 years old of age
  • No back or leg pain during walking

You may not qualify if:

  • Symptomatic hip or knee Ostearthritis
  • Not able to give their free consent
  • Being in a wheelchair (not able to walk 30 meters)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université du Québec à Trois-Rivières

Trois-Rivières, Quebec, G9A 5H7, Canada

Location

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 8, 2021

First Posted

March 12, 2021

Study Start

September 9, 2020

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

March 28, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations