Satisfaction and Quality of Life Among Prosthetic Users in Gaza Governorate , (PROINGA)

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.

Study Overview

• Status: Completed
• Conditions: Amputation; Prosthesis User; Satisfaction; Quality of Lifte
• Intervention / Treatment: Other: Observational Study - No Intervention

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 Type: Observational
• Enrollment (Actual): 128

Contacts and Locations

Study Locations

• Palestinian Territories
  • Gaza, Palestinian Territories
    • Gaza hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Observational Study - No Intervention; This study is purely observational; no interventions or treatments were performed. Participants only completed survey.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Agree1. 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.	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.	Baseline (one-time assessment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Quality of life was assessed using WHOQOL-BREF domain scores (physical, psychological, social, environmental). Higher scores indicate better quality of life	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.	Baseline (one-time assessment)

Collaborators and Investigators

• Sponsor: Yeditepe University
• Collaborators: Al-Azhar University - Gaza

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Actual): March 15, 2026
• Study Completion (Actual): March 25, 2026

Study Registration Dates

• First Submitted: August 21, 2025
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Quality of Life; Satisfaction; Prosthesis User
• Additional Relevant MeSH Terms: Behavior; Personal Satisfaction
• Other Study ID Numbers: PRO-2025-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No