Transtibial Amputation - UnilateralICFNCT07385859
Prosthetic Satisfaction, Body Image, and ICF Outcomes After Amputation
An observational study of Transtibial Amputation - Unilateral and Lower Limb Amputation Below Knee, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
Lower limb amputation affects not only physical mobility but also psychological well-being, body perception, and involvement in daily and social life. Although prosthetic use is essential for restoring mobility, rehabilitation outcomes may be influenced by multiple physical and psychosocial factors. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Transtibial Amputation - Unilateral, Lower Limb Amputation Below Knee, Body Image
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2025to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study population consisted of adults aged 18 to 64 years with unilateral transtibial lower limb amputation who had been using a prosthesis for at least one year. Participants were able to ambulate independently with a prosthesis and had no major neurological, musculoskeletal, cognitive, or psychiatric conditions affecting mobility or questionnaire completion. All participants were recruited from a single prosthetics and orthotics center and provided written informed consent prior to participation.
Who may be able to join
- Adults aged 18 to 64 years
- Unilateral transtibial lower limb amputation
- Use of a prosthesis for at least one year
- Ability to ambulate independently with a prosthesis
- Ability to read and understand questionnaires
- Voluntary participation with written informed consent
Who cannot join
- Congenital limb deficiency
- Bilateral lower limb amputation
- Neurological disorders affecting mobility (e.g., stroke, Parkinson's disease)
- Severe musculoskeletal conditions influencing gait or balance
- Recent prosthetic replacement within the previous six months
- Severe residual limb pain or uncontrolled phantom limb pain
- Cognitive or psychiatric impairment that could interfere with questionnaire completion
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayis University
Samsun, Atakum, 55270
About this study
Official title: Prosthetic Satisfaction, Body Image, and Activity-Participation After Unilateral Lower Limb Amputation: An ICF-Based Analysis
Lower limb amputation affects not only physical mobility but also psychological well-being, body perception, and involvement in daily and social life. Although prosthetic use is essential for restoring mobility, rehabilitation outcomes may be influenced by multiple physical and psychosocial factors. Understanding the relationships between prosthetic satisfaction, body image, and activity and participation may contribute to improved rehabilitation planning after amputation.
This observational, cross-sectional study aims to investigate the relationships between prosthetic satisfaction, body image, and activity and participation outcomes in adults with unilateral lower limb amputation who use a prosthesis. The study includes adults with unilateral transtibial amputation who have been using a prosthesis for daily activities.
Read more
Participants complete standardized self-report questionnaires to assess prosthetic satisfaction using the Trinity Amputation and Prosthesis Experience Scales, body image perception using the Amputee Body Image Scale, and activity and participation based on the International Classification of Functioning, Disability and Health (ICF) framework.
Activity outcomes focus on the ability to perform daily physical tasks such as standing, walking, stair negotiation, and mobility on different surfaces. Participation outcomes focus on involvement in daily routines, social interactions, transportation, work, and leisure activities.
Statistical analyses are planned to examine the associations between prosthetic satisfaction, body image, and activity and participation outcomes, while considering demographic and prosthesis-related factors such as age and duration of prosthesis use.
Read the detailed description
This observational, cross-sectional study is conducted within the framework of the International Classification of Functioning, Disability and Health (ICF) to explore psychosocial and functional aspects of rehabilitation after unilateral lower limb amputation. The study focuses on understanding how prosthetic-related and person-related factors jointly relate to activity performance and participation in daily life.
Participants are adults with unilateral transtibial amputation who have been using a prosthesis in daily life. The study adopts a biopsychosocial perspective, emphasizing that rehabilitation outcomes after amputation are not determined solely by physical capacity or prosthetic characteristics but also by psychological factors such as body image and subjective satisfaction with the prosthesis.
Prosthetic satisfaction is evaluated as a multidimensional construct reflecting comfort, functionality, and personal acceptance of the prosthesis, while body image is considered a key psychosocial factor influencing movement confidence, self-perception, and engagement in daily and social activities. Activity and participation are examined as distinct but related domains in accordance with the ICF conceptual model.
By examining the relationships between prosthetic satisfaction, body image, and ICF-based activity and participation outcomes, this study aims to contribute to a more comprehensive understanding of rehabilitation after lower limb amputation. The findings are expected to support patient-centered rehabilitation planning by highlighting psychosocial targets alongside prosthetic and functional considerations.
- Conditions
- Transtibial Amputation - Unilateral, Lower Limb Amputation Below Knee, Body Image, Activities of Daily Living, ICF, Participation
- Being tested
- No intervention (observational study)
- Keywords
- body image, Lower Limb Amputation, Activities of Daily Living, Social Participation, ICF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (observational study)Other
No intervention was administered as part of this study. This was an observational, cross-sectional study in which participants received no experimental treatment, device, or behavioral intervention. Data were collected during a single assessment session using self-report questionnaires to evaluate prosthetic satisfaction, body image, and activity and participation based on the International Classification of Functioning, Disability and Health (ICF) framework.
| Study group | Role | What they receive |
|---|---|---|
| Adults with Unilateral Lower Limb Amputation | This cohort consisted of adults with unilateral transtibial lower limb amputation who had been using a prosthesis for at least one year. Participants were able to ambulate independently with a prosthesis and had no significant neurological or musculoskeletal conditions affecting mobility. No experimental intervention was applied as part of the study. All participants underwent a single-session assessment including self-report questionnaires evaluating prosthetic satisfaction, body image, and activity and participation based on the International Classification of Functioning, Disability and Health (ICF) framework. Receives: Other: No intervention (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICF-Based Participation Score
Participation was assessed using an ICF-based participation questionnaire consisting of 9 items related to involvement in daily routines and social life, including indoor and outdoor mobility, use of public transportation, self-care, helping others, interpersonal interactions, employment, and leisure activities. Each item was scored on a 5-point scale ranging from 0 (no difficulty) to 4 (complete difficulty). Lower scores indicate better participation.
Measured: Baseline
ICF-Based Activity Score
Activity was assessed using an ICF-based activity questionnaire consisting of 8 items related to daily physical activities, including changing body position, standing, walking short and long distances, walking on different surfaces, negotiating obstacles, stair ambulation, and driving. Each item was scored on a 5-point scale ranging from 0 (no difficulty) to 4 (complete difficulty). Lower scores indicate better activity performance.
Measured: Baseline
Body Image (Amputee Body Image Scale, ABIS)
Body image perception is evaluated using the Amputee Body Image Scale (ABIS), a 20-item self-report questionnaire designed to assess body image disturbance in individuals with limb amputation. Each item is rated on a 5-point Likert scale. Total scores range from 20 to 100, with higher scores indicating greater body image disturbance.
Measured: Baseline
Prosthetic Satisfaction (Trinity Amputation and Prosthesis Experience Scales, TAPES) - Description
Prosthetic satisfaction is assessed using the Trinity Amputation and Prosthesis Experience Scales (TAPES). The prosthetic satisfaction domain evaluates satisfaction with prosthesis aesthetics, weight, and functional performance. Items are scored on a Likert scale, with total scores ranging from 3 to 15, and higher scores indicating greater prosthetic satisfaction.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start1 Apr 2025
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transtibial Amputation - UnilateralStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MİNE PEKESEN KURTÇA, Ondokuz Mayıs University
- Investigators
- Mine PEKESEN KURTÇA P PEKESEN KURTÇA, PhD, Principal investigator, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07385859
- Sponsor's protocol ID
- OMU2025/148
- Acronym
- ICF
- Status last verified
- Feb 2026
- First submitted
- 16 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to the small sample size and the sensitive nature of the clinical and psychosocial information collected. Data sharing was not included in the original informed consent.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prosthetic Satisfaction, Body Image, and Activity-Participation After Unilateral Lower Limb Amputation: An ICF-Based Analysis
- ClinicalTrials.gov ID
- NCT07385859
- Acronym / sponsor ID
- ICF / OMU2025/148
- Conditions
- Transtibial Amputation - Unilateral, Lower Limb Amputation Below Knee, Body Image, Activities of Daily Living, ICF, Participation
- Keywords
- body image, Lower Limb Amputation, Activities of Daily Living, Social Participation, ICF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 4 Feb 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.
Lower limb amputation affects not only physical mobility but also psychological well-being, body perception, and involvement in daily and social life. Although prosthetic use is essential for restoring mobility, rehabilitation outcomes may be influenced by multiple physical and psychosocial factors. Understanding the relationships between prosthetic satisfaction, body image, and activity and participation may contribute to improved rehabilitation planning after amputation.
This observational, cross-sectional study aims to investigate the relationships between prosthetic satisfaction, body image, and activity and participation outcomes in adults with unilateral lower limb amputation who use a prosthesis. The study includes adults with unilateral transtibial amputation who have been using a prosthesis for daily activities.
Participants complete standardized self-report questionnaires to assess prosthetic satisfaction using the Trinity Amputation and Prosthesis Experience Scales, body image perception using the Amputee Body Image Scale, and activity and participation based on the International Classification of Functioning, Disability and Health (ICF) framework.
Activity outcomes focus on the ability to perform daily physical tasks such as standing, walking, stair negotiation, and mobility on different surfaces. Participation outcomes focus on involvement in daily routines, social interactions, transportation, work, and leisure activities.
Statistical analyses are planned to examine the associations between prosthetic satisfaction, body image, and activity and participation outcomes, while considering demographic and prosthesis-related factors such as age and duration of prosthesis use.
Detailed description
This observational, cross-sectional study is conducted within the framework of the International Classification of Functioning, Disability and Health (ICF) to explore psychosocial and functional aspects of rehabilitation after unilateral lower limb amputation. The study focuses on understanding how prosthetic-related and person-related factors jointly relate to activity performance and participation in daily life.
Participants are adults with unilateral transtibial amputation who have been using a prosthesis in daily life. The study adopts a biopsychosocial perspective, emphasizing that rehabilitation outcomes after amputation are not determined solely by physical capacity or prosthetic characteristics but also by psychological factors such as body image and subjective satisfaction with the prosthesis.
Prosthetic satisfaction is evaluated as a multidimensional construct reflecting comfort, functionality, and personal acceptance of the prosthesis, while body image is considered a key psychosocial factor influencing movement confidence, self-perception, and engagement in daily and social activities. Activity and participation are examined as distinct but related domains in accordance with the ICF conceptual model.
By examining the relationships between prosthetic satisfaction, body image, and ICF-based activity and participation outcomes, this study aims to contribute to a more comprehensive understanding of rehabilitation after lower limb amputation. The findings are expected to support patient-centered rehabilitation planning by highlighting psychosocial targets alongside prosthetic and functional considerations.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with Unilateral Lower Limb Amputation | – | Other: No intervention (observational study)This cohort consisted of adults with unilateral transtibial lower limb amputation who had been using a prosthesis for at least one year. Participants were able to ambulate independently with a prosthesis and had no significant neurological or musculoskeletal conditions affecting mobility. No experimental intervention was applied as part of the study. All participants underwent a single-session assessment including self-report questionnaires evaluating prosthetic satisfaction, body image, and activity and participation based on the International Classification of Functioning, Disability and Health (ICF) framework. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population consisted of adults aged 18 to 64 years with unilateral transtibial lower limb amputation who had been using a prosthesis for at least one year. Participants were able to ambulate independently with a prosthesis and had no major neurological, musculoskeletal, cognitive, or psychiatric conditions affecting mobility or questionnaire completion. All participants were recruited from a single prosthetics and orthotics center and provided written informed consent prior to participation.
Key inclusion criteria (6 listed)
- Adults aged 18 to 64 years
- Unilateral transtibial lower limb amputation
- Use of a prosthesis for at least one year
- Ability to ambulate independently with a prosthesis
- Ability to read and understand questionnaires
Key exclusion criteria (7 listed)
- Congenital limb deficiency
- Bilateral lower limb amputation
- Neurological disorders affecting mobility (e.g., stroke, Parkinson's disease)
- Severe musculoskeletal conditions influencing gait or balance
- Recent prosthetic replacement within the previous six months
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 study)No intervention was administered as part of this study. This was an observational, cross-sectional study in which participants received no experimental treatment, device, or behavioral intervention. Data were collected during a single assessment session using self-report questionnaires to evaluate prosthetic satisfaction, body image, and activity and participation based on the International Classification of Functioning, Disability and Health (ICF) framework. | Other | Adults with Unilateral Lower Limb Amputation |
Primary outcome
ICF-Based Participation Score
Time frame: Baseline
Participation was assessed using an ICF-based participation questionnaire consisting of 9 items related to involvement in daily routines and social life, including indoor and outdoor mobility, use of public transportation, self-care, helping others, interpersonal interactions, employment, and leisure activities. Each item was scored on a 5-point scale ranging from 0 (no difficulty) to 4 (complete difficulty). Lower scores indicate better participation.
ICF-Based Activity Score
Time frame: Baseline
Activity was assessed using an ICF-based activity questionnaire consisting of 8 items related to daily physical activities, including changing body position, standing, walking short and long distances, walking on different surfaces, negotiating obstacles, stair ambulation, and driving. Each item was scored on a 5-point scale ranging from 0 (no difficulty) to 4 (complete difficulty). Lower scores indicate better activity performance.
Body Image (Amputee Body Image Scale, ABIS)
Time frame: Baseline
Body image perception is evaluated using the Amputee Body Image Scale (ABIS), a 20-item self-report questionnaire designed to assess body image disturbance in individuals with limb amputation. Each item is rated on a 5-point Likert scale. Total scores range from 20 to 100, with higher scores indicating greater body image disturbance.
Prosthetic Satisfaction (Trinity Amputation and Prosthesis Experience Scales, TAPES) - Description
Time frame: Baseline
Prosthetic satisfaction is assessed using the Trinity Amputation and Prosthesis Experience Scales (TAPES). The prosthetic satisfaction domain evaluates satisfaction with prosthesis aesthetics, weight, and functional performance. Items are scored on a Likert scale, with total scores ranging from 3 to 15, and higher scores indicating greater prosthetic satisfaction.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to the small sample size and the sensitive nature of the clinical and psychosocial information collected. Data sharing was not included in the original informed consent.
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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. This study is not recruiting at the moment.
Mine PEKESEN KURTÇA P PEKESEN KURTÇA, PhD principal investigator
Ondokuz Mayıs University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transtibial Amputation - Unilateral and Lower Limb Amputation Below Knee, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ICF-Based Participation Score (time frame: Baseline). The study lists 4 primary outcomes in all. 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 4 Feb 2026.