Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2026-02-26 @ 11:14 AM
Study NCT ID:
NCT04174027
Status:
UNKNOWN
Last Update Posted:
2019-11-22
First Post:
2019-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Perturbration on Balance Control in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-12-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2020-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-20', 'studyFirstSubmitDate': '2019-10-03', 'studyFirstSubmitQcDate': '2019-11-20', 'lastUpdatePostDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'movement inside the foot during balance control.', 'timeFrame': '30 minutes', 'description': 'The changes in center of pressure (COP) amplitude height'}], 'primaryOutcomes': [{'measure': 'static balance control in reaction to perturbration', 'timeFrame': '20 minutes', 'description': 'The angle velocity at the ankle at the moment of loosing postural control while standing'}, {'measure': 'dynamic balance control un reaction to perturbration', 'timeFrame': '10 minutes', 'description': 'the speed of perturbration at the moment of loosing balance while walking'}], 'secondaryOutcomes': [{'measure': 'Time to returning to original condition', 'timeFrame': '30 minutes', 'description': 'How much time it takes to come back to the original step (Center of Pressure - COP) after the perturbration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic ankle instability ( CAI )', 'Perturbration', 'reactive postural control', 'balance', 'center of pressure - COP'], 'conditions': ['Chronic Ankle Instability']}, 'descriptionModule': {'briefSummary': 'Balance control in respond to an unexpected platform perturbration during standing and walking: comparison between individuals with chronic ankle instability and healthy individuals.', 'detailedDescription': 'An unexpected postural perturbration is a major risk factor of falls and injuries during gait. A postural perturbration is a sudden change in conditions that displaces the body posture away from equilibrium. Reactive postural control response is an immediate ( 70-120 ms ) automatic "like reflex" response which is initiated by unexpected postural perturbration in order to maintain balance. Even among young healthy adults there could be a problem in balance performance which does not become evident untill a slip or a trip or any other sudden perturbration happens. Thus a simple test of pertubration while standing or walking can identify a problem .\n\nThis study is comparing the reactive postural control of physical education students who suffer from chronic ankle instability (CAI) to healthy students on a Perturbation Treadmill. The device consists of a treadmill mounted on a moving force plate platform. The platform moves in the medial/ lateral plains to simulate a slip and a trip in both the standing and walking phase. Their reactive postural control is tested in a few conditions: standing on both legs - eyes open and eyes closed, in tandem standing, standing on one leg and in walking. In each condition the perturbration is given every 5-15 seconds in different speed and in unexpected direction (right /left). Lost of balance control is any change in the original location of the foot in standing conditions or stepping out of the treadmill.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Physical education students from Zinman College in Wingate', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18-50\n* good health\n* active people\n\nExclusion Criteria:\n\n* Body weight greater than 135 kg\n* Bone instability (non-consolidated fractures, unstable spinal column, severe osteoporosis)\n* Head damage in the year prior to the study\n* Diabetics or Unstable circulation\n* Cardiac (blood) contraindications\n* Vestibular problem\n* Neurological deficits\n* Mechanical ventilation problem\n* Severe vascular disorders of the lower limbs'}, 'identificationModule': {'nctId': 'NCT04174027', 'briefTitle': 'The Effect of Perturbration on Balance Control in Adults', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'The Effect of Perturbration on Balance Control in Adults', 'orgStudyIdInfo': {'id': 'MeirMc102-19CTIL'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Alon Eliakim, MD', 'role': 'CONTACT', 'email': 'Eliakim.Alon@clalit.org.il', 'phone': '972-9-7471596'}, {'name': 'Michal Pantanowitz, PhD', 'role': 'CONTACT', 'email': 'michal.pantanowitz@clalit.org.il', 'phone': '972-9-7471596'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}