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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04250753
Other study ID # UQTR-2019-claudication
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2019
Est. completion date December 30, 2024

Study information

Verified date December 2023
Source Université du Québec à Trois-Rivières
Contact Martin Descarreaux, PhD
Phone 819 376-5011
Email martin.descarreaux@uqtr.ca
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 30, 2024
Est. primary completion date November 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with lumbar spinal stenosis - Presenting neurogenic claudication - Waiting for a surgery (laminectomy, laminotomy, fusion) Exclusion Criteria: - Symptomatic hip or knee osteoarthritis

Study Design


Intervention

Other:
Walking task
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.

Locations

Country Name City State
Canada Université du Québec à Trois-Rivières Trois-Rivieres Quebec

Sponsors (1)

Lead Sponsor Collaborator
Université du Québec à Trois-Rivières

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary Change from baseline Walking time Time participants take to do the walking task in seconds Baseline, 6 weeks post-surgery
Primary 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
Primary Change from baseline Gait cycle Gait cycle (% stance phase, % swing phase) Baseline, 6 weeks post-surgery
Primary 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 Change from baseline Swing Width Swing Width (m) is the maximal lateral excursion of the foot during swing phase. It is the maximum lateral distance between the forward path and the real path of the foot. Baseline, 6 weeks post-surgery
Secondary Change from baseline Minimal To Clearance Min. Toe Clearance (meter) is the minimum height of the toes during swing phase. Baseline, 6 weeks post-surgery
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