Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07127250

Interest of Walking Sticks to Increase Walking Activity of People With Sagittal Imbalance of Spine

The purpose of this pilot study is to assess the impact of using walking sticks on walking perimeter in people with anterior spinal imbalance.

Recruiting

Interested in participating?

Request Info

Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de rééducation et de réadaptation de l'appareil locomoteur et des pathologies du rachis.Hôpital Cochin

Paris, 75014, France

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult ≥ 50 years
  • VAS (Sagittal Vertical Axis, C7-S1, EoS (clinical follow-up)) > 5cm
  • Able to do transfers alone
  • Able to walk 10 minutes or 400 meters in a row
  • Self-reported Walking difficulties
  • Person living at home
  • Person willing and consenting to participate in the study
  • Health insurance

Exclusion criteria

  • Current use of walking sticks
  • Advanced and symptomatic osteoarthritis of the lower limbs
  • Static disorder of the fixed spine
  • Introduction of a straightening brace in the 3 months preceding the start of the study
  • Static disorder explained by infectious, tumoral, congenital or neurodegenerative pathologies
  • Uncompensated lower-limb length inequality (> 2cm)
  • Lower limb motor deficit
  • Upper limb pathology preventing cane use
  • Proprioceptive or vestibular pathology
  • Inability to write, speak or read French
  • Cognitive and/or behavioral disorders
  • Participation in other research on spinal balance and/or gait, or that could influence these factors during the study period
  • People under tutorship or curatorship
  • Free state medical assistance

Treatment and study plan

Walking sticks

Other

Walking with walking sticks and pedometer Daily walking activity recorded in a logbook

Primary outcomes

  1. Walking perimeter

    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

Secondary outcomes

  1. Number of daily steps

    Time frame: Periods Day 1-Day 7 and Day 8-Month 3

    Daily steps measured by pedometer

  2. Walking perimeter

    Time frame: Day 0 and month 3

    6-minute walk test at Day 0 without walking sticks and 3 months later without walking sticks

  3. Postural stability parameters

    Time frame: Day 0 and month 3

    Postural stability parameters (measured on a stabilometry platform, Abilycare).

  4. Spatio-temporal walking parameters

    Time frame: Day 0 and Month 3

    Variation in spatio-temporal walking parameters (measured on a GaitRite treadmill

  5. Number of falls in the last 3 months

    Time frame: Day 0 and Month 3

  6. Mean spinal pain

    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)

  7. Activity limitation

    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)

  8. Quality of life

    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).

  9. Participant's opinions on the use of sticks collected

    Time frame: Month 3

    Using open and closed questions

Study contacts

Contact information is provided by the study sponsor or research team.

Laetitia PEAUDECERF, PhD

CONTACT

[email protected]

01 71 76 07 99 ext. +33

Rémy FLECHON

CONTACT

[email protected]

01.58.41.41.41 Poste 18608 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 17, 2025
Registry last updated
Apr 3, 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.