NCT07379320

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
8mo left

Started Jan 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress31%
Jan 2026Dec 2026

First Submitted

Initial submission to the registry

January 23, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 30, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

January 30, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Expected
Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

1 month

First QC Date

January 23, 2026

Last Update Submit

January 23, 2026

Conditions

Lower Limb Amputation

Keywords

Lower limb amputationPerceived social supportPsychometric validationReliabilityValidity

Outcome Measures

Primary Outcomes (1)

  • Validity and reliability of the Multidimensional Scale of Perceived Social Support

    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 Outcomes (3)

  • Psychosocial adjustment assessed by the Trinity Amputation and Prosthesis Experience Scales

    Baseline

  • Participation level assessed by the Reintegration to Normal Living Index

    Baseline

  • Health-related quality of life assessed by the Nottingham Health Profile

    Baseline

Study Arms (1)

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.

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational CohortOTHER

This is an observational study. No therapeutic or behavioral intervention is administered. Participants only complete questionnaire-based assessments.

Lower Limb Amputation Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 23, 2026

First Posted

January 30, 2026

Study Start

January 30, 2026

Primary Completion

March 15, 2026

Study Completion (Estimated)

December 15, 2026

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share