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OpenTrials
Completed

NCT Number: NCT07519746

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

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.

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Key information

Conditions

Amputation Behavior Personal Satisfaction Prosthesis User Quality of Lifte Satisfaction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gaza hospitals

Gaza, Palestinian Territories

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational study - no intervention

Other

This study is purely observational; no interventions or treatments were performed. Participants only completed survey.

Primary outcomes

  1. 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:

    • = 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.

  2. 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.

Secondary outcomes

  1. Quality of life

    Time frame: Baseline (one-time assessment)

    Quality of life was assessed using WHOQOL-BREF domain scores (physical, psychological, social, environmental). Higher scores indicate better quality of life

  2. Health-related quality of life

    Time frame: Baseline (one-time assessment)

    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.

Sponsors and collaborators

Lead sponsor

Yeditepe University

Other

Collaborators

  • Al-Azhar University - Gaza

Registry information

Official study title

Patient Satisfaction and Quality of Life Among Lower Limb Prosthetic Users in Gaza Governorate During Gaza War

Acronym: PROINGA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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