Service de rééducation et de réadaptation de l'appareil locomoteur et des pathologies du rachis.Hôpital Cochin
Paris, 75014, France
Location status: Recruiting
NCT Number: NCT07127250
The purpose of this pilot study is to assess the impact of using walking sticks on walking perimeter in people with anterior spinal imbalance.
Interested in participating?
Request Info50 year and older
All sexes
Interventional
Not applicable
Paris, 75014, France
Location status: Recruiting
Aging is associated with a number of highly prevalent spinal pathologies, characterized by static disorders affecting spinal balance in the sagittal plane especially. These postural disorders are a source of pain, activity limitation and reduced quality of life. Treatment of spinal static disorders is essentially symptomatic based on medical care and rehabilitation and includes the use of spinal orthosis. Adherence to spinal orthosis is poor.
Walking requires dynamic stabilization capacities, which are affected by static disorders of the spine. In the case of walking difficulties associated with sagittal imbalance of spine, the walking aid most frequently assessed in the literature is the rollator. Using a rollator promotes anterior flexion of the spine and prevents physiological dissociation of the scapular and pelvic girdles.
Walking sticks help maintain sagittal alignment of the spine, improving the subject's dynamic stability while respecting the physiological gait pattern (dissociation of the scapular and pelvic belts).
To date, no study has assessed the impact of using walking sticks to increase walking activity in a population of people with sagittal imbalance of spine.
Deterioration in overall spinal balance and reduced stabilization capabilities are associated with increased risk of falls.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Walking with walking sticks and pedometer Daily walking activity recorded in a logbook
Time frame: Day 0 and month 3 (+ 15 days, 13 to 15 weeks)
6-minute walk test at Day 0 without walking sticks and 3 months later with walking sticks
Time frame: Periods Day 1-Day 7 and Day 8-Month 3
Daily steps measured by pedometer
Time frame: Day 0 and month 3
6-minute walk test at Day 0 without walking sticks and 3 months later without walking sticks
Time frame: Day 0 and month 3
Postural stability parameters (measured on a stabilometry platform, Abilycare).
Time frame: Day 0 and Month 3
Variation in spatio-temporal walking parameters (measured on a GaitRite treadmill
Time frame: Day 0 and Month 3
Time frame: Day 0 and Month 3
Variation in the average intensity of spinal pain (in the last 48 hours) (Numerical Scale, 0: no pain, 10: maximum imaginable pain)
Time frame: Day 0 and Month 3
Variation in activity limitation assessed by the self-completed Oswestry Disability Index (ODI, 0-50, no activity limitation; 50 maximum limitation)
Time frame: Day 0 and Month 3
Variation in specific quality of life assessed by the Scoliosis Research Society-22 revised self-assessment questionnaire (SRS-22r, for each of the 5 domains, score from 1: minimum quality of life to 5: maximum quality of life).
Time frame: Month 3
Using open and closed questions
Contact information is provided by the study sponsor or research team.
Laetitia PEAUDECERF, PhD
CONTACT
01 71 76 07 99 ext. +33
Rémy FLECHON
CONTACT
01.58.41.41.41 Poste 18608 ext. +33
Assistance Publique - Hôpitaux de Paris
Other
Interest of Walking Sticks to Increase Walking Activity of People With Sagittal Imbalance of Spine: a Comparative Exploratory Study (Before-after) Using Mixed Methodology.
Acronym: WALKSPINE
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.