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Clinical Trials/NCT05513326
NCT05513326
Recruiting
Not Applicable

Effectiveness of a 6-week Specific Rehabilitation Program Combining Education and Exercises on Walking Capacity in Patients with Lumbar Spinal Stenosis with Neurogenic Claudication

Université du Québec à Trois-Rivières1 site in 1 country66 target enrollmentJanuary 26, 2023
ConditionsSpinal Stenosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal Stenosis
Sponsor
Université du Québec à Trois-Rivières
Enrollment
66
Locations
1
Primary Endpoint
Change from baseline in walking capacity
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The aim of this study is to determine the effectiveness of a 6-week specific rehabilitation program combining education and exercises on walking capacity in patients with LSS causing NC.

The intervention group will receive standardized education and specific exercises while the control group will only receive standardized education. The program in both groups will last for 6 weeks with 4 evaluation timepoints (baseline, week 2, week 4 and post-intervention assessment). The primary outcomes will be walking capacity measured with the Self-Paced Walking Test and the secondary outcomes will be back and leg pain intensity, LSS-related disability, self-efficacy, level of physical activity, anxiety and depression, physical activity level, gait pattern characteristics, balance, and global perceived change.

Registry
clinicaltrials.gov
Start Date
January 26, 2023
End Date
December 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Martin Descarreaux

Professor

Université du Québec à Trois-Rivières

Eligibility Criteria

Inclusion Criteria

  • being at least 50 years old
  • having a degenerative central LSS alone or in combination with other LSS types (e.g. foraminal, lateral) and/or a spondylolisthesis affecting one or multiple vertebral levels, confirmed by clinical history, physical examination and proper imaging
  • having NC associated with LSS
  • being able to speak and understand French
  • being willing to attend 3 intervention sessions per week
  • with a duration of signs and symptoms of at least 3 months
  • (7) being able to walk at least 20 meters without walking aid, but not being able to walk continuously for 30 minutes
  • being able to provide informed written consent.

Exclusion Criteria

  • congenital LSS,
  • symptomatic osteoarthritis (hip or knee) causing limited walking capacity
  • neurological disease affecting walking capacity such as Parkinson
  • uncontrolled diabetes
  • heart failure
  • intermittent claudication of vascular origin
  • impaired cognitive capacity
  • back or lower extremities surgery in the past 3 months

Outcomes

Primary Outcomes

Change from baseline in walking capacity

Time Frame: Baseline, week 2, week 4, week 6, week 12

Walking capacity measure with the Self-Paced Walking Test (time)

Secondary Outcomes

  • Change from baseline in leg and back pain intensity(Baseline, week 2, week 4, week 6, week 12)
  • Change from baseline in lower extremity physical function and balance(Baseline, week 6, week 12)
  • Change from baseline in lumbar spinal stenosis related disabiltity(Baseline, week 6, week 12)
  • Change from baseline in anxiety and depression(Baseline, week 6, week 12)
  • Change from baseline in biomechanical parameters of gait(Baseline, week 2, week 4, week 6, week 12)
  • Changes from baseline in self-efficacy(Baseline, week 6, week 12)
  • Change from baseline in physical activity level(Baseline, week 6, week 12)
  • Patient's global impression of change(changes of the global impression of change throughout the study (baseline, week 2, week 4, week 6, week 12))

Study Sites (1)

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