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Assessment of Gait Parameters and Their Impact on Postoperative Recovery in Patients With Lumbar Spinal Stenosis: a Feasibility Study

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ClinicalTrials.gov Identifier: NCT04250753
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : January 31, 2020
Sponsor:
Information provided by (Responsible Party):
Martin Descarreaux, Université du Québec à Trois-Rivières

Brief Summary:
The first aim is to evaluate the integration's feasibility of a research project linked to the walking parameters into the clinical process pre and postoperative for patient with lumbar spinal stenosis who consult in neurosurgery. The second 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.

Condition or disease Intervention/treatment
Lumbar Spinal Stenosis Other: Walking task

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 8 Months
Official Title: Assessment of Gait Parameters and Their Impact on Postoperative Recovery in Patients With Lumbar Spinal Stenosis: a Feasibility Study
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

Group/Cohort Intervention/treatment
Patients with lumbar spinal stenosis 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.




Primary Outcome Measures :
  1. Change from baseline French-Canadian adaptation of Swiss Spinal Stenosis Questionnaires (FC-SSSQ) [ Time Frame: Baseline, 6 weeks post-surgery, 6 months post-surgery ]
    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.

  2. Change from baseline Quality of life (EuroQol - 5D) [ Time Frame: Baseline, 6 weeks post-surgery, 6 months post-surgery ]
    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.

  3. Change from baseline International Physical Activity Questionnaire (IPAQ) [ Time Frame: Baseline, 6 weeks post-surgery, 6 months post-surgery ]
    physical activity habits. IPAQ score range from 1 to 3 where a score of 3 indicates a higher practice of physical activity

  4. Change from baseline Walking time [ Time Frame: Baseline, 6 weeks post-surgery ]
    Time participants take to do the walking task in seconds

  5. Change from baseline Walking speed [ Time Frame: Baseline, 6 weeks post-surgery ]
    the walking stride velocity (meter/second) is the mean speed of forward walking, calculated in meters per second

  6. Change from baseline Gait cycle [ Time Frame: Baseline, 6 weeks post-surgery ]
    Gait cycle (% stance phase, % swing phase)

  7. Change from baseline Stride length [ Time Frame: Baseline, 6 weeks post-surgery ]
    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.


Secondary Outcome Measures :
  1. Change from baseline Swing Width [ Time Frame: Baseline, 6 weeks post-surgery ]
    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.

  2. Change from baseline Minimal To Clearance [ Time Frame: Baseline, 6 weeks post-surgery ]
    Min. Toe Clearance (meter) is the minimum height of the toes during swing phase.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients older than 18 years old with lumbar spinal stensois
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Symptomatic hip or knee osteoarthritis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04250753


Contacts
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Contact: Martin Descarreaux, PhD 819 376-5011 ext 3791 martin.descarreaux@uqtr.ca

Locations
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Canada, Quebec
Université du Québec à Trois-Rivières Recruiting
Trois-Rivieres, Quebec, Canada, G9A 5H7
Contact: Martin Descarreaux, DC, PhD    1-819-376-5011 ext 3791    martin.descarreaux@uqtr.ca   
Sponsors and Collaborators
Université du Québec à Trois-Rivières
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Responsible Party: Martin Descarreaux, Professor, Université du Québec à Trois-Rivières
ClinicalTrials.gov Identifier: NCT04250753    
Other Study ID Numbers: UQTR-2019-claudication
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Martin Descarreaux, Université du Québec à Trois-Rivières:
neurogenic claudication
gait parameters
walking impairment
Additional relevant MeSH terms:
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Spinal Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases