Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-29 @ 4:12 AM
Study NCT ID:
NCT05891912
Status:
UNKNOWN
Last Update Posted:
2023-06-07
First Post:
2023-05-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Active Aging With Technological Devices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The assessors will be independent to the study and will be blinded to the treatment received by the patients.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a pre-test post-test study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-26', 'studyFirstSubmitDate': '2023-05-15', 'studyFirstSubmitQcDate': '2023-05-26', 'lastUpdatePostDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from the cognitive impairment measured with the Minimental State Examination at 13 weeks , 17 weeks and 21 weeks', 'timeFrame': 'It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)', 'description': 'The Mini-Mental State Examination (MMSE) is a set of 11 questions that doctors and other healthcare professionals commonly use to check for cognitive impairment.\n\nAny score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment.'}, {'measure': 'Change from the Activities of daily living performance measured with the Barthel Index at 13 weeks , 17 weeks and 21 weeks', 'timeFrame': 'It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)', 'description': 'The Barthel Scale/Index is an ordinal scale used to measure performance in activities of daily living (ADL). Ten variables describing ADL and mobility are scored, a higher number being a reflection of greater ability to function independently following hospital discharge.\n\nEach item is rated in terms of whether the patient can perform the task independently, with some assistance, or is dependent on help based on observation (0=unable, 1=needs help, 2=independent). The final score is x 5 to get a number on a 100 point score. Proposed guidelines for interpreting Barthel scores are that scores of 0-20 indicate "total" dependency, 21-60 indicate "severe" dependency, 61-90 indicate "moderate" dependency, and 91-99 indicates "slight" dependency.2 Most studies apply the 60/61 cutting point.'}, {'measure': 'Change from the Depression level measured with the Yesavage Geriatric Depression Scale (GDS) at 13 weeks , 17 weeks and 21 weeks', 'timeFrame': 'It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)', 'description': 'The The Yesavage Geriatric Depression Scale (GDS) is an assessment tool for diagnosing depression in older adults and expresses the degree of satisfaction, quality of life and feelings. (GDS) is an assessment tool for diagnosing depression in older adults and expresses the degree of satisfaction, quality of life and feelings.\n\nScores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.'}, {'measure': 'Change from Instrumental Activities of Daily Living performance measured with The Lawton Instrumental Activities of Daily Living (IADL) Scale at 13 weeks , 17 weeks and 21 weeks', 'timeFrame': 'It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)', 'description': 'The Lawton Instrumental Activities of Daily Living Scale (IADL) is an appropriate instrument to assess independent living skills. These skills are considered more complex than the basic activities of daily living as measured by the Katz Index of ADLs (See Try this: Katz Index of ADLs). The instrument is most useful for identifying how a person is functioning at the present time, and to identify improvement or deterioration over time. There are eight domains of function measured with the Lawton IADL scale.\n\nScores range from 0 (low function, dependent) to 8 (high function, independent) for women, and 0 through 5 for men.'}], 'secondaryOutcomes': [{'measure': 'Change from the balance and gait performance measured with the Tinetti test at 13 weeks , 17 weeks and 21 weeks', 'timeFrame': 'It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)', 'description': "The Tinetti-test, also called Performance-Oriented Mobility Assessment (POMA) assesses a person's perception of balance and stability during activities of daily living and their fear of falling. It is a very good indicator of the fall risk of an individual.\n\nThe test comprises two short sections that contain one examining static balance abilities in a chair and then standing, and the other gait It has better test-retest, discriminative and predictive validities concerning fall risk than other tests including Timed Up and Go test (TUG), one-leg stand and functional reach test.\n\nThe Tinetti test has a gait score and a balance score. It uses a 3-point ordinal scale of 0, 1 and 2. Gait is scored over 12 and balance is scored over 16 totalling 28. The lower the score on the Tinetti test, the higher the risk of falling.\n\nTineti tool score: Risk of fall: ≤ 18 High, 19-23 Moderate, ≥ 24 Low"}, {'measure': 'Change from the upper limb range of movement at 13 weeks , 17 weeks and 21 weeks', 'timeFrame': 'It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)', 'description': 'The range of movement of the wrist, elbow and shoulder will be measured with the goniometer'}, {'measure': 'Change from the Reaction speed or number of attempts during the sessions at 13 weeks , 17 weeks and 21 weeks', 'timeFrame': 'It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)', 'description': 'The data related to the reaction speed or number of attempts during the sessions and each game performed will be measured and registered by the technological devices'}, {'measure': 'Change from the Number of correct tries in each game at 13 weeks , 17 weeks and 21 weeks', 'timeFrame': 'It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)', 'description': 'The data related to the number of correct tries in each game performed will be measured and registered by the technological devices'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['older adults,'], 'conditions': ['Older Adults Institutionalized in Residential Homes']}, 'descriptionModule': {'briefSummary': 'Clinical trial with users of health care centres and nursing homes in Extremadura (Spain). Inclusion criteria are: women and men over 55 years of age with a Minimental State Examination (MMSE) equal or higher than 21 (no cognitive impairment or mild to moderate cognitive impairment) who are able to walk independently. Exclusion criteria are: patients with severe cognitive impairment or language impairment that prevents the use of verbal communication, non-autonomous gait and severe limitation of mobility at the level of the upper limb.\n\nTreatment schedule: 30 min sessions, twice a week during 12 weeks\n\n* 1 session per week: 15min small TABLET and 15min LIGHTS game.\n* 1 session per week: 15min TABLE TABLET and 15min game of grape harvesting.\n\nThe intervention will be carried out by occupational therapists or physiotherapists.\n\nThe intervention period and evaluations will be performed as follows:\n\n* Training of Occupational therapists/physiotherapists: 1 week prior to the start of the intervention for.\n* Week 0- Initial measurements\n* Week 1-12: device interventions\n* Week 13: Final measurements\n* Week 17: First follow-up measurement\n* Week 21: Second follow-up measurement'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women and men over 50 years of age\n* Minimental State Examination (MMSE) equal or higher than 21 (no cognitive impairment or mild to moderate cognitive impairment)\n* Independent gait\n\nExclusion Criteria:\n\n* patients with severe cognitive impairment or language impairment that prevents the use of verbal communication\n* No independent gait\n* Severe limitation of upper limb range of movement.'}, 'identificationModule': {'nctId': 'NCT05891912', 'briefTitle': 'Active Aging With Technological Devices', 'organization': {'class': 'OTHER', 'fullName': 'University of Extremadura'}, 'officialTitle': 'Effects of Technological Devices in Older Adults', 'orgStudyIdInfo': {'id': '03/2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Technological devices intervention', 'description': 'The intervention will be in individual sessions with the following technological devices and games:\n\n* Vertical screen: game of lights and vintage game.\n* Horizontal screen: cognitive function and activities of daily living games\n* Tablets: cognitive function and activities of daily living games', 'interventionNames': ['Other: Technological devices intervention (use of tablet and big screen with games oriented to training physical and cognitive function)']}], 'interventions': [{'name': 'Technological devices intervention (use of tablet and big screen with games oriented to training physical and cognitive function)', 'type': 'OTHER', 'description': 'The treatment will be performed in 30 min sessions, twice a week during 12 weeks. the weekly sessions will include the following games:\n\n* 1 session per week: 15min small TABLET and 15min LIGHTS game.\n* 1 session per week: 15min TABLE TABLET and 15min game of VINTAGE.', 'armGroupLabels': ['Technological devices intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10003', 'city': 'Cáceres', 'state': 'Extremadura', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Maria Trinidad Rodriguez-Domínguez, Phd', 'role': 'CONTACT', 'email': 'trdomin@unex.es', 'phone': '0034 927 257450'}], 'facility': 'University of Extremadura', 'geoPoint': {'lat': 39.47649, 'lon': -6.37224}}], 'centralContacts': [{'name': 'ELISA MARIA GARRIDO-ARDILA, PhD', 'role': 'CONTACT', 'email': 'egarridoa@unex.es', 'phone': '0034 927 257450', 'phoneExt': '21500'}, {'name': 'Maria Trinidad Rodríguez-Dominguez, PhD', 'role': 'CONTACT', 'email': 'trdomin@unex.es'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Extremadura', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Elisa María Garrido Ardila', 'investigatorAffiliation': 'University of Extremadura'}}}}