AmputationPROINGANCT07519746
Satisfaction and Quality of Life Among Prosthetic Users in Gaza Governorate ,
An observational study of Amputation and Prosthesis User, run by Yeditepe University at 1 site in Palestinian Territories.
Trial summary
Prosthetic devices help amputees regain mobility and improve appearance. When patients are satisfied with their prosthesis, they are more likely to use it consistently, leading to better rehabilitation outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation, Prosthesis User, Satisfaction
- How many people
- 128 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 1 Sep 2025to 25 Mar 2026
- How long will I take part?
- 1 Day
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include adult lower limb prosthetic users aged 18 years and older who have been using a prosthesis continuously for at least six months. Participants will be recruited from Gaza governorate. Both males and females are eligible. Individuals with cognitive impairments or medical, neurological, or psychological conditions that prevent completion of study procedures will be excluded.
Who may be able to join
- Adults aged 18 years or older
- Continuous use of a lower limb prosthesis for at least six months prior to enrollment
- Ability to understand and respond to questionnaires or interviews
Who cannot join
- Cognitive impairments that affect comprehension or communication
- Medical, neurological, or psychological conditions that prevent completion of study procedures
- Inability or unwillingness to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Satisfaction and Quality of Life Among Lower Limb Prosthetic Users in Gaza Governorate During Gaza War
Prosthetic devices help amputees regain mobility and improve appearance. When patients are satisfied with their prosthesis, they are more likely to use it consistently, leading to better rehabilitation outcomes.
In Gaza, the 2023 Gaza War caused a rise in traumatic amputations and limited access to healthcare and prosthetic services. This makes rehabilitation more difficult, affecting both physical and mental health.
Research on patient satisfaction and quality of life (QoL) among lower limb prosthetic users in Gaza is limited. This study evaluates satisfaction and QoL in this population, aiming to provide information to improve prosthetic care and guide interventions tailored to local needs.
Read the detailed description
Lower limb amputation has significant physical and psychological impacts, affecting mobility, daily activities, and quality of life (QoL). In Gaza, traumatic amputations increased following the 2023 war, limiting access to prosthetic and rehabilitation services.
This a cross-sectional observational study evaluates adult lower limb prosthetic users (≥18 years, using prosthesis ≥6 months) in Gaza. Data is collected via structured questionnaires covering:
- Part I: Sociodemographic Data - age, gender, BMI, marital status, education, employment, income, residence, living arrangement, healthcare access.
- Part II: Clinical Characteristics - amputation level and cause, time since amputation, prosthesis type, duration/frequency of use, comorbidities, prosthetic complications, rehabilitation services received.
- Part III: Patient Satisfaction - satisfaction with healthcare services regarding quality, communication, comfort, and responsiveness, measured using [Prosthetic Satisfaction Questionnaire].
- Part IV: Prosthetic Satisfaction - comfort, fit, functionality, and durability of prosthesis, assessed with [Prosthetic Satisfaction Questionnaire].
- Part V: Quality of Life (QoL) - physical, psychological, and social well-being, measured with EQ-5D-5L and Satisfaction with Life Scale (SWLS).
Data analysis will include descriptive statistics for satisfaction and QoL scores, correlations between patient satisfaction and QoL, and associations with sociodemographic variables using regression models.
The study aims to inform prosthetic care delivery and guide context-specific interventions in Gaza, contributing to better functional recovery and psychological adjustment for lower limb amputees.
- Conditions
- Amputation, Prosthesis User, Satisfaction, Quality of Lifte
- Being tested
- Observational Study - No Intervention
- Keywords
- Prosthesis User, Quality of Life, Satisfaction
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational Study - No InterventionOther
This study is purely observational; no interventions or treatments were performed. Participants only completed survey.
| Study group | Role | What they receive |
|---|---|---|
| Participants completed a survey assessing satisfaction .No interventions were performed | Adult participants (≥18 years) completed a survey assessing sociodemographic characteristics, clinical characteristics, patient satisfaction with healthcare and prosthesis, and quality of life (QoL) outcomes. No interventions were performed; this is an observational study. Receives: Other: Observational Study - No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction With Life Scale (SWLS)
Life satisfaction was assessed using the Satisfaction With Life Scale (SWLS). Total scores range from 5 to 35, with higher scores indicating greater life satisfaction among lower limb prosthetic users in Gaza governorate.
The items are:
- = Strongly Disagree
- = Disagree
- = Slightly Disagree
- = Neither Agree or Disagree
- = Slightly Agree
- = Agree
- = Strongly Agree
- 1. In most ways my life is close to my ideal.
- 2. The conditions of my life are excellent.
- 3. I am satisfied with life.
- 4. So far I have gotten the important things I want in life.
- 5. If I could live my life over, I would change almost nothing.
Measured: Baseline (one-time assessment)
Prosthetic satisfaction
Prosthetic satisfaction was assessed using a structured interview adapted from the Satisfaction with Prosthesis Questionnaire (SAT-PRO), Prosthesis Evaluation Questionnaire (PEQ), and Trinity Amputation and Prosthesis Experience Scales (TAPES). The interview includes items evaluating satisfaction, comfort, embarrassment during prosthesis use, and expectation fulfillment. Responses are recorded using dichotomous (Yes/No) and ordinal response options, with higher scores indicating greater prosthetic satisfaction and adaptation.
Measured: Baseline (one-time assessment)
Secondary outcomes (2)
Quality of life
Quality of life was assessed using WHOQOL-BREF domain scores (physical, psychological, social, environmental). Higher scores indicate better quality of life
Measured: Baseline (one-time assessment)
Health-related quality of life
Health-related quality of life was measured using the EQ-5D-5L index score. The EQ-5D-5L assesses five dimensions including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Higher index scores indicate better perceived health status.
Measured: Baseline (one-time assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start1 Sep 2025
- Primary completion15 Mar 2026
- Study completion25 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 128 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Al-Azhar University - Gaza
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519746
- Sponsor's protocol ID
- PRO-2025-01
- Acronym
- PROINGA
- Status last verified
- Apr 2026
- First submitted
- 21 Aug 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) will not be shared due to the sensitive nature of the data collected from a vulnerable population in Gaza and to ensure participant confidentiality and privacy.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction and Quality of Life Among Lower Limb Prosthetic Users in Gaza Governorate During Gaza War
- ClinicalTrials.gov ID
- NCT07519746
- Acronym / sponsor ID
- PROINGA / PRO-2025-01
- Conditions
- Amputation, Prosthesis User, Satisfaction, Quality of Lifte
- Keywords
- Prosthesis User, Quality of Life, Satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Collaborators
- Al-Azhar University - Gaza
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 15 Mar 2026 (actual)
- Study completion
- 25 Mar 2026 (actual)
- First posted
- 9 Apr 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.
Prosthetic devices help amputees regain mobility and improve appearance. When patients are satisfied with their prosthesis, they are more likely to use it consistently, leading to better rehabilitation outcomes.
In Gaza, the 2023 Gaza War caused a rise in traumatic amputations and limited access to healthcare and prosthetic services. This makes rehabilitation more difficult, affecting both physical and mental health.
Research on patient satisfaction and quality of life (QoL) among lower limb prosthetic users in Gaza is limited. This study evaluates satisfaction and QoL in this population, aiming to provide information to improve prosthetic care and guide interventions tailored to local needs.
Detailed description
Lower limb amputation has significant physical and psychological impacts, affecting mobility, daily activities, and quality of life (QoL). In Gaza, traumatic amputations increased following the 2023 war, limiting access to prosthetic and rehabilitation services.
This a cross-sectional observational study evaluates adult lower limb prosthetic users (≥18 years, using prosthesis ≥6 months) in Gaza. Data is collected via structured questionnaires covering:
- Part I: Sociodemographic Data - age, gender, BMI, marital status, education, employment, income, residence, living arrangement, healthcare access.
- Part II: Clinical Characteristics - amputation level and cause, time since amputation, prosthesis type, duration/frequency of use, comorbidities, prosthetic complications, rehabilitation services received.
- Part III: Patient Satisfaction - satisfaction with healthcare services regarding quality, communication, comfort, and responsiveness, measured using [Prosthetic Satisfaction Questionnaire].
- Part IV: Prosthetic Satisfaction - comfort, fit, functionality, and durability of prosthesis, assessed with [Prosthetic Satisfaction Questionnaire].
- Part V: Quality of Life (QoL) - physical, psychological, and social well-being, measured with EQ-5D-5L and Satisfaction with Life Scale (SWLS).
Data analysis will include descriptive statistics for satisfaction and QoL scores, correlations between patient satisfaction and QoL, and associations with sociodemographic variables using regression models.
The study aims to inform prosthetic care delivery and guide context-specific interventions in Gaza, contributing to better functional recovery and psychological adjustment for lower limb amputees.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants completed a survey assessing satisfaction .No interventions were performed | – | Other: Observational Study - No InterventionAdult participants (≥18 years) completed a survey assessing sociodemographic characteristics, clinical characteristics, patient satisfaction with healthcare and prosthesis, and quality of life (QoL) outcomes. No interventions were performed; this is an observational study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include adult lower limb prosthetic users aged 18 years and older who have been using a prosthesis continuously for at least six months. Participants will be recruited from Gaza governorate. Both males and females are eligible. Individuals with cognitive impairments or medical, neurological, or psychological conditions that prevent completion of study procedures will be excluded.
Key inclusion criteria (3 listed)
- Adults aged 18 years or older
- Continuous use of a lower limb prosthesis for at least six months prior to enrollment
- Ability to understand and respond to questionnaires or interviews
Key exclusion criteria (3 listed)
- Cognitive impairments that affect comprehension or communication
- Medical, neurological, or psychological conditions that prevent completion of study procedures
- Inability or unwillingness to provide informed consent
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 |
|---|---|---|
| Observational Study - No InterventionThis study is purely observational; no interventions or treatments were performed. Participants only completed survey. | Other | Participants completed a survey assessing satisfaction .No interventions were performed |
Primary outcome
Satisfaction With Life Scale (SWLS)
Time frame: Baseline (one-time assessment)
Life satisfaction was assessed using the Satisfaction With Life Scale (SWLS). Total scores range from 5 to 35, with higher scores indicating greater life satisfaction among lower limb prosthetic users in Gaza governorate. The items are: 1. = Strongly Disagree 2. = Disagree 3. = Slightly Disagree 4. = Neither Agree or Disagree 5. = Slightly Agree 6. = Agree 7. = Strongly Agree * 1. In most ways my life is close to my ideal. * 2. The conditions of my life are excellent. * 3. I am satisfied with life. * 4. So far I have gotten the important things I want in life. * 5. If I could live my life over, I would change almost nothing.
Prosthetic satisfaction
Time frame: Baseline (one-time assessment)
Prosthetic satisfaction was assessed using a structured interview adapted from the Satisfaction with Prosthesis Questionnaire (SAT-PRO), Prosthesis Evaluation Questionnaire (PEQ), and Trinity Amputation and Prosthesis Experience Scales (TAPES). The interview includes items evaluating satisfaction, comfort, embarrassment during prosthesis use, and expectation fulfillment. Responses are recorded using dichotomous (Yes/No) and ordinal response options, with higher scores indicating greater prosthetic satisfaction and adaptation.
2 secondary outcomes
Quality of life
Time frame: Baseline (one-time assessment)
Health-related quality of life
Time frame: Baseline (one-time assessment)
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 9 Apr 2026.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) will not be shared due to the sensitive nature of the data collected from a vulnerable population in Gaza and to ensure participant confidentiality and privacy.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Amputation and Prosthesis User, run by Yeditepe University at 1 site in Palestinian Territories.
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 3 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: finished, as of the sponsor's last update on 9 Apr 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 Palestinian Territories. 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?
Satisfaction With Life Scale (SWLS) (time frame: Baseline (one-time assessment)). The study lists 2 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 9 Apr 2026.