NCT07519746

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 9, 2026

Completed
Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

August 21, 2025

Last Update Submit

April 2, 2026

Conditions

Keywords

Prosthesis UserQuality of LifeSatisfaction

Outcome Measures

Primary Outcomes (2)

  • 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: 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.

    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 Outcomes (2)

  • Quality of life

    Baseline (one-time assessment)

  • Health-related quality of life

    Baseline (one-time assessment)

Study Arms (1)

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

Interventions

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

Participants completed a survey assessing satisfaction .No interventions were performed

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaza hospitals

Gaza, Palestinian Territories

Location

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2025

First Posted

April 9, 2026

Study Start

September 1, 2025

Primary Completion

March 15, 2026

Study Completion

March 25, 2026

Last Updated

April 9, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.

Locations