NCT04250753

Brief Summary

The objective is to observe the evolution of walking parameters during the surgery process and find which of all calculated walking parameters represent the best indicators of functional disabilities and postoperative recovery for patient with lumbar spinal stenosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2019

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

November 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2020

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

May 11, 2026

Status Verified

May 1, 2026

Enrollment Period

6 years

First QC Date

January 29, 2020

Last Update Submit

May 7, 2026

Conditions

Keywords

neurogenic claudicationgait parameterswalking impairment

Outcome Measures

Primary Outcomes (7)

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

    pain, function and satisfaction related to lumbar spinal stenosis. Pain subscale score range from 7 to 35 with higher values indicate a worst outcome, Function subscale score range from 5 to 20 with higher values indicate a worst outcome, Satisfaction subscale score range from 6 to 24 with higher values indicate a worst outcome. The total score is composed of the three subscales and range from 18 to 79.

    Baseline, 6 weeks post-surgery, 6 months post-surgery

  • Change from baseline Quality of life (EuroQol - 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.

    Baseline, 6 weeks post-surgery, 6 months post-surgery

  • Change from baseline 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

    Baseline, 6 weeks post-surgery, 6 months post-surgery

  • Change from baseline Walking time

    Time participants take to do the walking task in seconds

    Baseline, 6 weeks post-surgery

  • Change from baseline Walking speed

    the walking stride velocity (meter/second) is the mean speed of forward walking, calculated in meters per second

    Baseline, 6 weeks post-surgery

  • Change from baseline Gait cycle

    Gait cycle (% stance phase, % swing phase)

    Baseline, 6 weeks post-surgery

  • Change from baseline Stride length

    Stride Length \[m\] describes the distance between two successive footprints on the ground, from the heel of a foot to the heel of the same foot, one cycle after.

    Baseline, 6 weeks post-surgery

Secondary Outcomes (2)

  • Change from baseline Swing Width

    Baseline, 6 weeks post-surgery

  • Change from baseline Minimal To Clearance

    Baseline, 6 weeks post-surgery

Study Arms (1)

Patients with lumbar spinal stenosis

Other: Walking task

Interventions

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

Patients with lumbar spinal stenosis

Eligibility Criteria

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

Patients older than 18 years old with lumbar spinal stensois

You may qualify if:

  • Patients with lumbar spinal stenosis
  • Presenting neurogenic claudication
  • Waiting for a surgery (laminectomy, laminotomy, fusion)

You may not qualify if:

  • Symptomatic hip or knee osteoarthritis

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
PROSPECTIVE
Target Duration
8 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 29, 2020

First Posted

January 31, 2020

Study Start

November 1, 2019

Primary Completion

November 1, 2025

Study Completion

December 30, 2025

Last Updated

May 11, 2026

Record last verified: 2026-05

Locations