Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2026-01-02 @ 7:40 AM
Study NCT ID:
NCT07127250
Status:
RECRUITING
Last Update Posted:
2025-12-16
First Post:
2025-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interest of Walking Sticks to Increase Walking Activity of People With Sagittal Imbalance of Spine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002183', 'term': 'Canes'}], 'ancestors': [{'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2025-07-16', 'studyFirstSubmitQcDate': '2025-08-11', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Walking perimeter', 'timeFrame': 'Day 0 and month 3 (+ 15 days, 13 to 15 weeks)', 'description': '6-minute walk test at Day 0 without walking sticks and 3 months later with walking sticks'}], 'secondaryOutcomes': [{'measure': 'Number of daily steps', 'timeFrame': 'Periods Day 1-Day 7 and Day 8-Month 3', 'description': 'Daily steps measured by pedometer'}, {'measure': 'Walking perimeter', 'timeFrame': 'Day 0 and month 3', 'description': '6-minute walk test at Day 0 without walking sticks and 3 months later without walking sticks'}, {'measure': 'Postural stability parameters', 'timeFrame': 'Day 0 and month 3', 'description': 'Postural stability parameters (measured on a stabilometry platform, Abilycare).'}, {'measure': 'Spatio-temporal walking parameters', 'timeFrame': 'Day 0 and Month 3', 'description': 'Variation in spatio-temporal walking parameters (measured on a GaitRite treadmill'}, {'measure': 'Number of falls in the last 3 months', 'timeFrame': 'Day 0 and Month 3'}, {'measure': 'Mean spinal pain', 'timeFrame': 'Day 0 and Month 3', 'description': 'Variation in the average intensity of spinal pain (in the last 48 hours) (Numerical Scale, 0: no pain, 10: maximum imaginable pain)'}, {'measure': 'Activity limitation', 'timeFrame': 'Day 0 and Month 3', 'description': 'Variation in activity limitation assessed by the self-completed Oswestry Disability Index (ODI, 0-50, no activity limitation; 50 maximum limitation)'}, {'measure': 'Quality of life', 'timeFrame': 'Day 0 and Month 3', 'description': '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).'}, {'measure': "Participant's opinions on the use of sticks collected", 'timeFrame': 'Month 3', 'description': 'Using open and closed questions'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Walking sticks', 'Walking distance', 'Static spinal disorder', 'Spinal static disorder', 'Anterior imbalance of spine', 'Pedometer'], 'conditions': ['Static Spinal Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this pilot study is to assess the impact of using walking sticks on walking perimeter in people with anterior spinal imbalance.', 'detailedDescription': "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.\n\nWalking 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.\n\nWalking 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).\n\nTo 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.\n\nDeterioration in overall spinal balance and reduced stabilization capabilities are associated with increased risk of falls."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult ≥ 50 years\n* VAS (Sagittal Vertical Axis, C7-S1, EoS (clinical follow-up)) \\> 5cm\n* Able to do transfers alone\n* Able to walk 10 minutes or 400 meters in a row\n* Self-reported Walking difficulties\n* Person living at home\n* Person willing and consenting to participate in the study\n* Health insurance\n\nExclusion Criteria:\n\n* Current use of walking sticks\n* Advanced and symptomatic osteoarthritis of the lower limbs\n* Static disorder of the fixed spine\n* Introduction of a straightening brace in the 3 months preceding the start of the study\n* Static disorder explained by infectious, tumoral, congenital or neurodegenerative pathologies\n* Uncompensated lower-limb length inequality (\\> 2cm)\n* Lower limb motor deficit\n* Upper limb pathology preventing cane use\n* Proprioceptive or vestibular pathology\n* Inability to write, speak or read French\n* Cognitive and/or behavioral disorders\n* Participation in other research on spinal balance and/or gait, or that could influence these factors during the study period\n* People under tutorship or curatorship\n* Free state medical assistance'}, 'identificationModule': {'nctId': 'NCT07127250', 'acronym': 'WALKSPINE', 'briefTitle': 'Interest of Walking Sticks to Increase Walking Activity of People With Sagittal Imbalance of Spine', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Interest of Walking Sticks to Increase Walking Activity of People With Sagittal Imbalance of Spine: a Comparative Exploratory Study (Before-after) Using Mixed Methodology.', 'orgStudyIdInfo': {'id': 'APHP250475'}, 'secondaryIdInfos': [{'id': 'IDRCB', 'type': 'REGISTRY', 'domain': '2025-A00608-41'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Walking sticks', 'interventionNames': ['Other: Walking sticks']}], 'interventions': [{'name': 'Walking sticks', 'type': 'OTHER', 'description': 'Walking with walking sticks and pedometer Daily walking activity recorded in a logbook', 'armGroupLabels': ['Walking sticks']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'facility': "Service de rééducation et de réadaptation de l'appareil locomoteur et des pathologies du rachis.Hôpital Cochin", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Rémy FLECHON', 'role': 'CONTACT', 'email': 'remy.flechon@aphp.fr', 'phone': '01.58.41.41.41 Poste 18608', 'phoneExt': '+33'}, {'name': 'Laetitia PEAUDECERF, PhD', 'role': 'CONTACT', 'email': 'laetitia.peaudecerf@aphp.fr', 'phone': '01 71 76 07 99', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Alexandra ROREN', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}, {'name': 'Rémy FLECHON', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}