Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT04210518
Status:
COMPLETED
Last Update Posted:
2019-12-24
First Post:
2019-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Balance Training With Stroboscopic Vision
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020886', 'term': 'Somatosensory Disorders'}], 'ancestors': [{'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'An independent assessor blinded to the data collection was responsible for the allocation process. A list of the computer-generated number was employed to assign participants to balance training group, balance training with stroboscopic glasses group or control group.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study was a single-blinded randomized controlled trial with two intervention groups consisted in multimodal balance training, multimodal balance training in addition to stroboscopic glasses and control group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-20', 'studyFirstSubmitDate': '2019-12-08', 'studyFirstSubmitQcDate': '2019-12-20', 'lastUpdatePostDateStruct': {'date': '2019-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ankle range of motion', 'timeFrame': 'From baseline to six weeks.', 'description': 'Ankle dorsiflexion range of motion was assessed by the weight-bearing lunge test. The patient is positioned in a standing position facing a wall with the involved foot parallel with a tape measure which has been attached to the floor and the opposite leg placed behind in a tandem stance. A forward lunge is performed until the anterior knee tries to make contact with the wall with the heel firmly planted on the ground.'}, {'measure': 'Dynamic balance', 'timeFrame': 'From baseline to six weeks.', 'description': 'Dynamic balance has been measured by a simplified version of the Star Excursion Balance Test where the anterior, posteromedial and posterolateral reach directions were collected for statistical analysis.'}], 'secondaryOutcomes': [{'measure': 'Self-reported instability and function', 'timeFrame': 'From baseline to six weeks.', 'description': 'To determine the severity of ankle instability the Cumberland ankle instability tool. This questionnaire is a nine items questionnaire ranged from 0 to 30 (0 related with severe impairment and 30 no subjective instability feeling) and has been reported to be a valid tool with high internal consistency and reliability.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ankle Inversion Sprain', 'Proprioceptive Disorders']}, 'descriptionModule': {'briefSummary': 'Balance training with stroboscopic vision in patients with chronic ankle instability.', 'detailedDescription': 'This study was a single-blinded randomized controlled trial with two intervention groups consisted in multimodal balance training, multimodal balance training in addition to stroboscopic glasses and control group who received no intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a previous episode of ankle sprain in at least 6 months before the beginning of the study\n* a score of 25 or less in the Cumberland Ankle Instability Tool\n* no history of others musculoskeletal injuries in the lower limbs\n\nExclusion Criteria:\n\n* an acute ankle sprain within the last six weeks\n* Recent lower limb surgery'}, 'identificationModule': {'nctId': 'NCT04210518', 'briefTitle': 'Balance Training With Stroboscopic Vision', 'organization': {'class': 'OTHER', 'fullName': 'University of Jaén'}, 'officialTitle': 'Influence of Stroboscopic Vision on Balance in Patients With Chronic Ankle Instability', 'orgStudyIdInfo': {'id': 'UJASB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neuromuscular training', 'description': 'Neuromuscular training consisting of:\n\n* Single limb balance task.\n* Balance training on an unstable surface.\n* Hop drills.', 'interventionNames': ['Other: Neuromuscular training']}, {'type': 'EXPERIMENTAL', 'label': 'Stroboscopic glasses group', 'description': 'This group performed the same neuromuscular training with the addition of stroboscopic glasses during the training performance.\n\n* Single limb balance task.\n* Balance training on unstable surfaces.\n* Hop drills.', 'interventionNames': ['Other: Stroboscopic glasses']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'This group received no intervention'}], 'interventions': [{'name': 'Neuromuscular training', 'type': 'OTHER', 'description': "This intervention consisted of a supervised multimodal exercise protocol addressing different aspects of balance including static and dynamic tasks on the injured ankle. The training program comprised 6 exercises that were progressively adapted depending on the patient's execution controlled by an expert physiotherapist", 'armGroupLabels': ['Neuromuscular training']}, {'name': 'Stroboscopic glasses', 'type': 'OTHER', 'description': 'Patients included in this group performed the same protocol described in the balance training group with the addition of the stroboscopic glasses during the intervention.', 'armGroupLabels': ['Stroboscopic glasses group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23071', 'city': 'Jaén', 'country': 'Spain', 'facility': 'University of Jaen', 'geoPoint': {'lat': 37.76922, 'lon': -3.79028}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jaén', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Miami', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'DAVID CRUZ DÍAZ', 'investigatorAffiliation': 'University of Jaén'}}}}