- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07379320
Psychometric Evaluation of the Multidimensional Scale of Perceived Social Support in Lower Extremity Amputation
Validity and Reliability of the Multidimensional Scale of Perceived Social Support in Individuals With Lower Extremity Amputation
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.
Participants 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Individuals 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.
Reliability 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.
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Individuals aged 18 years and older.
- Individuals with unilateral or bilateral lower extremity amputation.
- Ability to read and understand Turkish.
- Ability to provide informed consent and complete self-reported questionnaires.
Exclusion Criteria:
- Presence of severe cognitive impairment or neurological disorders that may affect comprehension of the questionnaires.
- Presence of acute psychiatric conditions that may interfere with participation.
- Presence of additional medical conditions that significantly limit communication or cooperation.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Lower Limb Amputation Cohort
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.
|
This is an observational study.
No therapeutic or behavioral intervention is administered.
Participants only complete questionnaire-based assessments.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Validity and reliability of the Multidimensional Scale of Perceived Social Support
Time Frame: Baseline and 3-7 days
|
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.
|
Baseline and 3-7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychosocial adjustment assessed by the Trinity Amputation and Prosthesis Experience Scales
Time Frame: Baseline
|
Psychosocial adjustment, activity restriction, and prosthesis satisfaction will be assessed using the Trinity Amputation and Prosthesis Experience Scales in individuals with lower extremity amputation.
|
Baseline
|
|
Participation level assessed by the Reintegration to Normal Living Index
Time Frame: Baseline
|
Participation in daily and social life will be assessed using the Reintegration to Normal Living Index.
|
Baseline
|
|
Health-related quality of life assessed by the Nottingham Health Profile
Time Frame: Baseline
|
Health-related quality of life will be assessed using the Nottingham Health Profile.
|
Baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- FTREK25-161
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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