Static Spinal DisorderWALKSPINENCT07127250
Interest of Walking Sticks to Increase Walking Activity of People With Sagittal Imbalance of Spine
A study testing Walking sticks in people with Static Spinal Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this pilot study is to assess the impact of using walking sticks on walking perimeter in people with anterior spinal imbalance. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Static Spinal Disorder
- What is being tested?
- Walking sticks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 25 Nov 2025to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de rééducation et de réadaptation de l'appareil locomoteur et des pathologies du rachis.Hôpital Cochin
Paris, 75014
About this study
Official 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.
The purpose of this pilot study is to assess the impact of using walking sticks on walking perimeter in people with anterior spinal imbalance.
Read the 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.
- Conditions
- Static Spinal Disorder
- Being tested
- Walking sticks
- Keywords
- Walking sticks, Walking distance, Static spinal disorder, Spinal static disorder, Anterior imbalance of spine, Pedometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking sticksOther
Walking with walking sticks and pedometer Daily walking activity recorded in a logbook
| Study group | Role | What they receive |
|---|---|---|
| Walking sticks | Experimental | Not described Receives: Other: Walking sticks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking perimeter
6-minute walk test at Day 0 without walking sticks and 3 months later with walking sticks
Measured: Day 0 and month 3 (+ 15 days, 13 to 15 weeks)
Secondary outcomes (9)
Number of daily steps
Daily steps measured by pedometer
Measured: 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
Measured: Day 0 and month 3
Postural stability parameters
Postural stability parameters (measured on a stabilometry platform, Abilycare).
Measured: Day 0 and month 3
Spatio-temporal walking parameters
Variation in spatio-temporal walking parameters (measured on a GaitRite treadmill
Measured: Day 0 and Month 3
Number of falls in the last 3 months
Measured: 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)
Measured: 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)
Measured: 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).
Measured: Day 0 and Month 3
Participant's opinions on the use of sticks collected
Using open and closed questions
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start25 Nov 2025
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Static Spinal DisorderStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Alexandra ROREN, Study director, Assistance Publique - Hôpitaux de ParisRémy FLECHON, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127250
- Sponsor's protocol ID
- APHP250475
- Other IDs
- IDRCB
- Acronym
- WALKSPINE
- Status last verified
- Mar 2026
- First submitted
- 16 Jul 2025
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07127250
- Acronym / sponsor ID
- WALKSPINE / APHP250475
- Conditions
- Static Spinal Disorder
- Keywords
- Walking sticks, Walking distance, Static spinal disorder, Spinal static disorder, Anterior imbalance of spine, Pedometer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot study is to assess the impact of using walking sticks on walking perimeter in people with anterior spinal imbalance.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Walking sticks | Experimental | Other: Walking sticks |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walking sticksWalking with walking sticks and pedometer Daily walking activity recorded in a logbook | Other | Walking sticks |
Primary outcome
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
9 secondary outcomes
Number of daily steps
Time frame: Periods Day 1-Day 7 and Day 8-Month 3
Walking perimeter
Time frame: Day 0 and month 3
Postural stability parameters
Time frame: Day 0 and month 3
Spatio-temporal walking parameters
Time frame: Day 0 and Month 3
Number of falls in the last 3 months
Time frame: Day 0 and Month 3
Mean spinal pain
Time frame: Day 0 and Month 3
Activity limitation
Time frame: Day 0 and Month 3
Quality of life
Time frame: Day 0 and Month 3
Participant's opinions on the use of sticks collected
Time frame: Month 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexandra ROREN study director
Assistance Publique - Hôpitaux de Paris
Rémy FLECHON principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking sticks in people with Static Spinal Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rémy FLECHON (01.58.41.41.41 Poste 18608 ext. +33, remy.flechon@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking perimeter (time frame: Day 0 and month 3 (+ 15 days, 13 to 15 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.