Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 9:00 PM
Study NCT ID:
NCT07333768
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-12
First Post:
2025-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EQUISOCK: New Antiequine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-31', 'studyFirstSubmitDate': '2025-12-08', 'studyFirstSubmitQcDate': '2025-12-31', 'lastUpdatePostDateStruct': {'date': '2026-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Device Feasibility', 'timeFrame': 'Baseline and up to 4 weeks', 'description': "Device feasibility will be assessed through participants' awareness of the device, as an indicator of its accessibility, visibility, and potential for effective implementation within the target population. A self diary Will be requested"}], 'secondaryOutcomes': [{'measure': 'Ankle function with virtual reality', 'timeFrame': 'Baseline and up to 4 weeks', 'description': 'Ankle function will be assessed using a virtual reality programme that requires movement of the lower limb to assess ankle stability, with and without orthosis. The assessment will be using a Borg scale (range of effort that the individual perceives when exercising). From 0 points (minimum effort) to 10 points (maximum effort).'}, {'measure': 'Range of motion with Gyko device', 'timeFrame': 'Baseline and up to 4 weeks', 'description': 'The range of motion of the knee joint will be measured using the Gyko device with and without the new orthosis. The assessment will be in degrees (from 0 to 120º)'}, {'measure': 'Footprint with a pressure platform', 'timeFrame': 'Baseline and up to 4 weeks', 'description': 'The distribution of static and dynamic load will be assessed with and without orthosis, using a pressure platform, as well as static balance with eyes open and closed and dynamic balance. The assessment will be the percentage of support from the sole of the foot in each movement.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ankle (Ligaments); Instability (Old Injury)', 'Ankle Equinus', 'Ankle Dorsiflexion']}, 'descriptionModule': {'briefSummary': "The goal of this experimental study is to test the feasibility and validity of a new orthosis in patients with ankle lesions (external popliteal sciatic nerve or nerve injuries resulting in loss of ankle dorsiflexion) of both sexes and all ages. The main question it aims to answer is:Is the new orthosis a support for ankle stability??Does the new orthosis improve ankle function and patients' quality of life??The control group will be the subjects themselves when wearing their conventional ankle orthosis or without it. Participants must wear the new ankle orthosis for at least one month to assess the effectiveness of the orthosis and evaluate any changes that have occurred in the ankle joint and muscles."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with chronic ankle injuries\n* patients with external popliteal sciatic nerve lesion or nerve injuries resulting in loss of ankle dorsiflexion\n* patients who have already been prescribed an orthosis\n* patients of all ages\n\nExclusion Criteria:\n\n* inability to stand actively and stably\n* inability to walk unaided\n* inability to follow instructions'}, 'identificationModule': {'nctId': 'NCT07333768', 'acronym': 'EQUISOCK', 'briefTitle': 'EQUISOCK: New Antiequine', 'organization': {'class': 'OTHER', 'fullName': 'University of Salamanca'}, 'officialTitle': 'EQUISOCK: New Antiequine for Ankle', 'orgStudyIdInfo': {'id': 'EQUISOCK2026'}, 'secondaryIdInfos': [{'id': 'University of Salamanca', 'type': 'OTHER_GRANT', 'domain': 'University of Salamanca'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EQUISOCK group', 'description': 'Participants must wear the new ankle orthosis during assessments and in their daily lives for at least one month, which is the duration of the study.', 'interventionNames': ['Device: EQUISOCK']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Other ankle orthosis', 'description': 'Participants must wear the conventional ankle orthosis (and without orthosis) during assessments and in their daily lives, before wear the new one.', 'interventionNames': ['Device: Other ankle orthosis']}], 'interventions': [{'name': 'EQUISOCK', 'type': 'DEVICE', 'description': 'Participants must wear the new ankle orthosis during assessments and in their daily lives for at least one month, which is the duration of the study.', 'armGroupLabels': ['EQUISOCK group']}, {'name': 'Other ankle orthosis', 'type': 'DEVICE', 'description': 'Participants must wear the conventional ankle orthosis and without orthosis, during assessments and before wearing the new one', 'armGroupLabels': ['Other ankle orthosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37007', 'city': 'Salamanca', 'state': 'Salamanca', 'country': 'Spain', 'contacts': [{'name': 'Rocio Llamas-Ramos', 'role': 'CONTACT', 'email': 'rociollamas@usal.es', 'phone': '+034657854188'}], 'facility': 'University of Salamanca', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}], 'centralContacts': [{'name': 'Rocio Llamas-Ramos Dr.', 'role': 'CONTACT', 'email': 'rociollamas@usal.es', 'phone': '+34657854188'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Salamanca', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Rocío Llamas-Ramos', 'investigatorAffiliation': 'University of Salamanca'}}}}