Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-04-12 @ 2:35 AM
Study NCT ID:
NCT02331004
Status:
COMPLETED
Last Update Posted:
2015-05-29
First Post:
2014-12-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of an Intervention Program for Fine Motor Skills
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006230', 'term': 'Hand Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-28', 'studyFirstSubmitDate': '2014-12-31', 'studyFirstSubmitQcDate': '2014-12-31', 'lastUpdatePostDateStruct': {'date': '2015-05-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Disability of the Arm, Shoulder and Hand (DASH) questionnaire at 8 weeks', 'timeFrame': 'Eight weeks'}, {'measure': 'Change from Baseline in Disability of the Arm, Shoulder and Hand (DASH) questionnaire at 16 weeks', 'timeFrame': 'Sixteen weeks'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in General self-efficacy at 8 weeks', 'timeFrame': 'Eight weeks'}, {'measure': 'Change from Baseline in General self-efficacy at 16 weeks', 'timeFrame': 'Sixteen weeks'}, {'measure': 'Change from Baseline in Purdue Pegboard Tests at 8 weeks', 'timeFrame': 'Eight weeks'}, {'measure': 'Change from Baseline in Purdue Pegboard Tests at 16 weeks', 'timeFrame': 'Sixteen weeks'}, {'measure': 'Change from Baseline in finger goniometer at 8 weeks', 'timeFrame': 'Eight weeks', 'description': 'Active and passive measures of motion in first, second and fifth fingers of dominant hand will be recorded .'}, {'measure': 'Change from Baseline in finger goniometer at 16 weeks', 'timeFrame': 'Sixteen weeks', 'description': 'Active and passive measures of motion in first, second and fifth fingers of dominant hand will be recorded .'}, {'measure': 'Change from Baseline in Pinch Gauge at 8 weeks', 'timeFrame': 'Eight weeks'}, {'measure': 'Change from Baseline in Pinch Gauge at 16 weeks', 'timeFrame': 'Sixteen weeks'}, {'measure': 'Change from Baseline in Short-Form health survey questionnaire (SF-36) at 8 weeks', 'timeFrame': 'Eight weeks'}, {'measure': 'Change from Baseline in Short-Form health survey questionnaire (SF-36) at 16 weeks', 'timeFrame': 'Sixteen weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Frail Elderly', 'Motor Skills', 'Upper Extremity'], 'conditions': ['Hand Injuries']}, 'descriptionModule': {'briefSummary': 'Investigators have created a protocol of intervention to treating the general disability of upper limbs.', 'detailedDescription': 'A protocol of intervention for fine motor skills will be performed on institutionalized elderly people.\n\nThis protocol consist on implementation of a manual activity that it is well known in the clinical setting.\n\nThis activity will enhance several skills such as strength, coordination of upper limbs, range of motion, general auto-efficacy and the quality of life.\n\nThe intervention or rehabilitation will be implemented for two month.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Institutionalized elderly people, on a full or part-time.\n* Voluntary participation.\n\nExclusion Criteria:\n\n* Cognitive impairment (\\< 23 in normal school population and \\< 20 points with a low education or illiteracy, in Spanish validation of Mini-Mental State Examination (MMSE)).\n* Postural control problems.\n* Balance disorders, while the subject is seated.'}, 'identificationModule': {'nctId': 'NCT02331004', 'briefTitle': 'Effectiveness of an Intervention Program for Fine Motor Skills', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Granada'}, 'officialTitle': 'Effectiveness of an Intervention Program for Fine Motor Skills in Institutionalized Elderly Residents: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Fine motor skills'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention for fine motor skills', 'description': 'Implementation of an well known activity to improve the function of upper extremities', 'interventionNames': ['Other: Intervention for fine motor skills']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Support to activities of daily living', 'description': 'Performing of general activities planned in the centres where the participants are included', 'interventionNames': ['Other: Support to activities of daily living']}], 'interventions': [{'name': 'Intervention for fine motor skills', 'type': 'OTHER', 'otherNames': ['Performing of a specific manual activity'], 'description': 'Implementation of an well known activity to improve the function of upper extremities', 'armGroupLabels': ['Intervention for fine motor skills']}, {'name': 'Support to activities of daily living', 'type': 'OTHER', 'otherNames': ['Performing of activities of daily living'], 'description': 'Participants are supported and orientated when they are performing some activity of daily living scheduled by the institution', 'armGroupLabels': ['Support to activities of daily living']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18016', 'city': 'Granada', 'state': 'Granada', 'country': 'Spain', 'facility': 'Maria Encarnación Aguilar Ferrandiz', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}], 'overallOfficials': [{'name': 'Mª Encarnacion ME Aguilar, PdH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad de Granada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Granada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Encarnación Aguilar Ferrandiz', 'investigatorFullName': 'Encarnación Aguilar Ferrandiz', 'investigatorAffiliation': 'Universidad de Granada'}}}}