Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-01-06 @ 7:13 AM
Study NCT ID:
NCT00817960
Status:
COMPLETED
Last Update Posted:
2012-06-20
First Post:
2009-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Ritalin on Postural Stability of Old Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008774', 'term': 'Methylphenidate'}], 'ancestors': [{'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-19', 'studyFirstSubmitDate': '2009-01-06', 'studyFirstSubmitQcDate': '2009-01-06', 'lastUpdatePostDateStruct': {'date': '2012-06-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postural sway measures', 'timeFrame': "Time 1: pre test' and hour later time 2: post testinng proceedure"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dual tasking', 'Postural Control', 'Methylphenidate (Ritalin)', 'old adults'], 'conditions': ['Postural Imbalance']}, 'descriptionModule': {'briefSummary': 'Experimental design overview The proposed project is a prospective experimental study design. independent old adults(age 65 years old and older) who do not suffer from balance problems willing to participate in the study will be tested with well-established measuring techniques of Balance control before and 2 hours after taking of Methylphenidate (Ritalin) in the movement and Rehabilitation Laboratory at BGU. An automated algorithm will be used to extract standardized stabilogram-diffusion parameters from each of the COP data sets collected during quiet standing. These parameters include diffusion coefficients, critical displacement, critical time and scaling exponents for both lateral and anterior-posterior sway directions (Collins \\& De Luca, 1993). For each of the conditions (before and 1 hour after the use of Ritalin) in three task conditions single task; dual task (concentrating and identifying specific music); and just Listening to a relaxing music. Participants will be required to stand on the platform 10 times for 30 s. For each trial, they will be instructed to sway as little as possible.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 65 years old and older\n* independent elderly adults\n* do not suffer from balance prblems\n* minimental score 24 and above\n\nExclusion Criteria:\n\n* old adults who suffer from neurological disease or stroke\n* old adults who suffer from psychiatric state\n* old adults who suffer from orthopedic condition (1/2 a year after a fracture in the lower limb)\n* old adults who suffer from heart conditions\n* old adults who suffer from blindness'}, 'identificationModule': {'nctId': 'NCT00817960', 'briefTitle': 'Effects of Ritalin on Postural Stability of Old Adults', 'organization': {'class': 'OTHER', 'fullName': 'Soroka University Medical Center'}, 'officialTitle': 'Effects of Methylphenidate on Postural Stability of Old Adults Under Single and Dual Task Conditions.', 'orgStudyIdInfo': {'id': 'SOR476508CTIL'}, 'secondaryIdInfos': [{'id': 'MZ4765'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Methylphenidate', 'interventionNames': ['Drug: Methylphenidate']}], 'interventions': [{'name': 'Methylphenidate', 'type': 'DRUG', 'description': 'The effect of ritalin on postural stability of old adults (65 years old and over) will be measured using RCT study design', 'armGroupLabels': ['Methylphenidate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84105', 'city': 'Beersheba', 'state': 'Israel', 'country': 'Israel', 'facility': 'SorokaUMC', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}], 'overallOfficials': [{'name': 'Itshak Melzer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ben-gurion University of the Negev, Beer-Sheva, Israel'}, {'name': 'Zmir Shorer, m', 'role': 'STUDY_CHAIR', 'affiliation': 'Soroka University Medical Centar'}, {'name': 'Yan Press, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Soroka University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soroka University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}