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

Interest of Walking Sticks to Increase Walking Activity of People With Sagittal Imbalance of Spine: a Comparative Exploratory Study (Before-after) Using Mixed Methodology.

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

Study Overview

• Status: Recruiting
• Conditions: Static Spinal Disorder
• Intervention / Treatment: Other: Walking sticks

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rémy FLECHON; Phone Number: +33 01.58.41.41.41 Poste 18608; Email: remy.flechon@aphp.fr
• Study Contact Backup: Name: Laetitia PEAUDECERF, PhD; Phone Number: +33 01 71 76 07 99; Email: laetitia.peaudecerf@aphp.fr

Study Locations

• France
  • Paris, France, 75014
    • Recruiting
    • Service de rééducation et de réadaptation de l'appareil locomoteur et des pathologies du rachis.Hôpital Cochin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Walking sticks	Other: Walking sticks; Walking with walking sticks and pedometer Daily walking activity recorded in a logbook

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Walking perimeter	6-minute walk test at Day 0 without walking sticks and 3 months later with walking sticks	Day 0 and month 3 (+ 15 days, 13 to 15 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of daily steps	Daily steps measured by pedometer	Periods Day 1-Day 7 and Day 8-Month 3
Walking perimeter	6-minute walk test at Day 0 without walking sticks and 3 months later without walking sticks	Day 0 and month 3
Postural stability parameters	Postural stability parameters (measured on a stabilometry platform, Abilycare).	Day 0 and month 3
Spatio-temporal walking parameters	Variation in spatio-temporal walking parameters (measured on a GaitRite treadmill	Day 0 and Month 3
Number of falls in the last 3 months		Day 0 and Month 3
Mean spinal pain	Variation in the average intensity of spinal pain (in the last 48 hours) (Numerical Scale, 0: no pain, 10: maximum imaginable pain)	Day 0 and Month 3
Activity limitation	Variation in activity limitation assessed by the self-completed Oswestry Disability Index (ODI, 0-50, no activity limitation; 50 maximum limitation)	Day 0 and Month 3
Quality of life	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).	Day 0 and Month 3
Participant's opinions on the use of sticks collected	Using open and closed questions	Month 3

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC-CIC Paris Descartes Necker Cochin
• Investigators: Study Director: Alexandra ROREN, Assistance Publique - Hôpitaux de Paris; Principal Investigator: Rémy FLECHON, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: July 16, 2025
• First Submitted That Met QC Criteria: August 11, 2025
• First Posted (Actual): August 17, 2025

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Pedometer; Walking distance; Walking sticks; Static spinal disorder; Spinal static disorder; Anterior imbalance of spine
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Canes
• Other Study ID Numbers: APHP250475; IDRCB (Registry Identifier: 2022-A02601-42)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No