Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-30 @ 12:06 AM
Study NCT ID:
NCT07379320
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-30
First Post:
2026-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychometric Evaluation of the Multidimensional Scale of Perceived Social Support in Lower Extremity Amputation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 55}, 'targetDuration': '7 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-23', 'studyFirstSubmitDate': '2026-01-23', 'studyFirstSubmitQcDate': '2026-01-23', 'lastUpdatePostDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validity and reliability of the Multidimensional Scale of Perceived Social Support', 'timeFrame': 'Baseline and 3-7 days', 'description': 'The validity and reliability of the Multidimensional Scale of Perceived Social Support will be evaluated using internal consistency, test-retest reliability, and construct validity analyses in individuals with lower extremity amputation.'}], 'secondaryOutcomes': [{'measure': 'Psychosocial adjustment assessed by the Trinity Amputation and Prosthesis Experience Scales', 'timeFrame': 'Baseline', 'description': 'Psychosocial adjustment, activity restriction, and prosthesis satisfaction will be assessed using the Trinity Amputation and Prosthesis Experience Scales in individuals with lower extremity amputation.'}, {'measure': 'Participation level assessed by the Reintegration to Normal Living Index', 'timeFrame': 'Baseline', 'description': 'Participation in daily and social life will be assessed using the Reintegration to Normal Living Index.'}, {'measure': 'Health-related quality of life assessed by the Nottingham Health Profile', 'timeFrame': 'Baseline', 'description': 'Health-related quality of life will be assessed using the Nottingham Health Profile.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lower limb amputation', 'Perceived social support', 'Psychometric validation', 'Reliability', 'Validity'], 'conditions': ['Lower Limb Amputation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the validity and reliability of the Multidimensional Scale of Perceived Social Support in individuals with lower extremity amputation. Social support plays an important role in psychological well-being, social participation, and adaptation after amputation. However, there is limited evidence regarding whether this scale accurately and consistently measures perceived social support in individuals with lower limb amputation.\n\nParticipants aged 18 years and older with lower extremity amputation will be invited to complete several questionnaires, including the Multidimensional Scale of Perceived Social Support. Some participants will complete the social support questionnaire a second time within a short period to evaluate the consistency of the results. The findings of this study are expected to contribute to the accurate assessment of perceived social support in individuals with lower limb amputation and to support future clinical and research applications.', 'detailedDescription': 'This methodological study aims to evaluate the validity and reliability of the Turkish version of the Multidimensional Scale of Perceived Social Support in individuals with lower extremity amputation. Perceived social support is a key psychosocial factor influencing psychological adjustment, social participation, and quality of life following amputation. Although the Multidimensional Scale of Perceived Social Support has been validated in various populations, its psychometric properties have not been sufficiently examined in individuals with lower limb amputation.\n\nIndividuals aged 18 years and older with lower extremity amputation will be recruited from routine clinical follow-up visits. Participants will complete a sociodemographic data form and standardized questionnaires assessing perceived social support, psychosocial adjustment, participation, and health-related quality of life. To assess test-retest reliability, the Multidimensional Scale of Perceived Social Support will be re-administered to a subgroup of participants within a 3 to 7-day interval.\n\nReliability will be evaluated using internal consistency and test-retest reliability analyses. Construct validity will be examined through correlations between perceived social support scores and related psychosocial and health measures. The results of this study will provide evidence regarding the psychometric adequacy of the Multidimensional Scale of Perceived Social Support for use in individuals with lower extremity amputation and will support its application in both clinical practice and research settings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of adults aged 18 years and older with lower extremity amputation who are attending routine clinical follow-up visits. Participants are individuals who are able to communicate in Turkish and who consent to participate in questionnaire-based assessments related to perceived social support and psychosocial outcomes.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals aged 18 years and older.\n* Individuals with unilateral or bilateral lower extremity amputation.\n* Ability to read and understand Turkish.\n* Ability to provide informed consent and complete self-reported questionnaires.\n\nExclusion Criteria:\n\n* Presence of severe cognitive impairment or neurological disorders that may affect comprehension of the questionnaires.\n* Presence of acute psychiatric conditions that may interfere with participation.\n* Presence of additional medical conditions that significantly limit communication or cooperation.'}, 'identificationModule': {'nctId': 'NCT07379320', 'briefTitle': 'Psychometric Evaluation of the Multidimensional Scale of Perceived Social Support in Lower Extremity Amputation', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Validity and Reliability of the Multidimensional Scale of Perceived Social Support in Individuals With Lower Extremity Amputation', 'orgStudyIdInfo': {'id': 'FTREK25-161'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lower Limb Amputation Cohort', 'description': 'This cohort includes adults aged 18 years and older with lower extremity amputation who are recruited during routine clinical follow-up visits. Participants will complete questionnaires assessing perceived social support and related psychosocial outcomes.', 'interventionNames': ['Other: No Intervention: Observational Cohort']}], 'interventions': [{'name': 'No Intervention: Observational Cohort', 'type': 'OTHER', 'description': 'This is an observational study. No therapeutic or behavioral intervention is administered. Participants only complete questionnaire-based assessments.', 'armGroupLabels': ['Lower Limb Amputation Cohort']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Fatih Erbahceci', 'investigatorAffiliation': 'Hacettepe University'}}}}