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Completed

NCT Number: NCT05513326

Effectiveness of a 6-week Specific Rehabilitation Program on Walking Capacity in Patients With Lumbar Spinal Stenosis

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.

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Key information

Conditions

Spinal Stenosis Behavior Bone Diseases Motor Activity Musculoskeletal Diseases Spinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Université du Québec à Trois-Rivières

Trois-Rivières, Quebec, G8Z 4M3, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercises and education

Other

Exercises: 3 training sessions per week that will last for 30 minutes. Sessions will start with 5 minutes of activation (walking on a treadmill or cycling). Then, participants will be asked to complete 5 exercises targeting lower limb strengthening (time: 18 minutes) followed by 2 exercises designed to improve balance and 3 stretching exercises for the lower limb (time: 7 minutes).

Education: Two one-on-one sessions (during week 2 and week 4 assessments) during which participants will receive information directly related to LSS and NC using illustration and videos. Participants will also be invited to ask their questions.

Education alone

Other

Education: Two one-on-one sessions (during week 2 and week 4 assessments) during which participants will receive information directly related to LSS and NC using illustration and videos. Participants will also be invited to ask their questions.

Primary outcomes

  1. 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

  1. Change from baseline in leg and back pain intensity

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

    Leg and back pain intensity will be independently assessed using a 11-point numerical rating scale (from 0 to 10 points). Higher score indicates higher pain.

  2. Change from baseline in lumbar spinal stenosis related disabiltity

    Time frame: Baseline, week 6, week 12

    Lumbar spinal stenosis related disability is measured with the French-Canadian version of the Swiss Spinal Stenosis Questionnaire. 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.

  3. Changes from baseline in self-efficacy

    Time frame: Baseline, week 6, week 12

    Measured with Self-efficacy measured with the French-Canadian Chronic Pain Self-Efficacy Scale. Each question is rated on a numerical scale (from 1 to 10). Total is calculated using the mean of the 33-items scores and ranges from 1 to 10 with a higher score indicate higher self-efficacy.

  4. Change from baseline in anxiety and depression

    Time frame: Baseline, week 6, week 12

    Measured with the French-Canadian adaptation of the Hospital Anxiety and Depression Scale. Total score range from 0 to 21 with higher score indicating symptoms of anxiety and/or depression.

  5. Change from baseline in physical activity level

    Time frame: Baseline, week 6, week 12

    Physical activity level assessed with the [Physical Activity Questionnaire for the Elderly]. The questionnaire allows to place participants into one of the 3 categories (low, moderate or high physical activity level). Physical activity level is measured in time per day.

  6. Patient's global impression of change

    Time frame: changes of the global impression of change throughout the study (baseline, week 2, week 4, week 6, week 12)

    Global impression of change will be measured using a 7-point scale that ranges from 'very much improved' to 'very much worse' with 'no change' as the mid-point.

  7. Change from baseline in biomechanical parameters of gait

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

    Spatio-temporal parameters of gait measured with wearable inertial sensors (velocity (m/s))

  8. Change from baseline in biomechanical parameters of gait

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

    Spatio-temporal parameters of gait measured with wearable inertial sensors measured in meters (stride length, swing witdh, toe clearance)

  9. Change from baseline in biomechanical parameters of gait

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

    Spatio-temporal parameters of gait measured with wearable inertial sensors measured in % (walking phases, assymetry, variability)

  10. Change from baseline in lower extremity physical function and balance

    Time frame: Baseline, week 6, week 12

    Lower extremity physical function and balance measured with the Short Physical Performance Battery. Total score ranges from 0 to 12 with higher score indicating a better lower extremity physical function and balance.

Sponsors and collaborators

Lead sponsor

Université du Québec à Trois-Rivières

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 24, 2022
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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