Lower Limb AmputationNCT07379320
Psychometric Evaluation of the Multidimensional Scale of Perceived Social Support in Lower Extremity Amputation
An observational study of Lower Limb Amputation, run by Hacettepe University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Limb Amputation
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2026to 15 Dec 2026
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Lower Limb Amputation
- Being tested
- No Intervention: Observational Cohort
- Keywords
- Lower limb amputation, Perceived social support, Psychometric validation, Reliability, Validity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
This is an observational study. No therapeutic or behavioral intervention is administered. Participants only complete questionnaire-based assessments.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 3-7 days
Secondary outcomes (3)
Psychosocial adjustment assessed by the Trinity Amputation and Prosthesis Experience Scales
Psychosocial adjustment, activity restriction, and prosthesis satisfaction will be assessed using the Trinity Amputation and Prosthesis Experience Scales in individuals with lower extremity amputation.
Measured: Baseline
Participation level assessed by the Reintegration to Normal Living Index
Participation in daily and social life will be assessed using the Reintegration to Normal Living Index.
Measured: Baseline
Health-related quality of life assessed by the Nottingham Health Profile
Health-related quality of life will be assessed using the Nottingham Health Profile.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start30 Jan 2026 (estimated)
- Primary completion15 Mar 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb AmputationStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Erbahceci, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07379320
- Sponsor's protocol ID
- FTREK25-161
- Status last verified
- Jan 2026
- First submitted
- 23 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Multidimensional Scale of Perceived Social Support in Individuals With Lower Extremity Amputation
- ClinicalTrials.gov ID
- NCT07379320
- Acronym / sponsor ID
- FTREK25-161
- Conditions
- Lower Limb Amputation
- Keywords
- Lower limb amputation, Perceived social support, Psychometric validation, Reliability, Validity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 30 Jan 2026 (estimated)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lower Limb Amputation Cohort | – | Other: No Intervention: Observational CohortThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortThis is an observational study. No therapeutic or behavioral intervention is administered. Participants only complete questionnaire-based assessments. | Other | Lower Limb Amputation Cohort |
Primary outcome
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.
3 secondary outcomes
Psychosocial adjustment assessed by the Trinity Amputation and Prosthesis Experience Scales
Time frame: Baseline
Participation level assessed by the Reintegration to Normal Living Index
Time frame: Baseline
Health-related quality of life assessed by the Nottingham Health Profile
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Limb Amputation, run by Hacettepe University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity and reliability of the Multidimensional Scale of Perceived Social Support (time frame: Baseline and 3-7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.