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NCT04855214 · ClinicalTrials.gov registry record

Evaluating the Experience of Upper Limb Prosthesis Use

A clinical trial of Amputation and Prosthesis User, sponsored by Louis Stokes VA Medical Center.

Recruiting
Registry status
178
Enrollment target
1
Study location

NCT04855214 is a study of Amputation and Prosthesis User that is actively recruiting participants, run by Louis Stokes VA Medical Center. The registered enrollment target is 178 participants, above the 130-participant average among 65 other Amputation trials with a reported enrollment target (37% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT04855214, a study of Amputation and Prosthesis User, is actively recruiting participants, sponsored by Louis Stokes VA Medical Center.

RECRUITING
Registry status
178 participants
Enrollment target
1
Study location

Study Summary

The goal is to understand the critical factors associated with outcome acceptance following upper limb loss. The investigators aim to develop a unified theoretical model that describes the psychosocial experience of upper limb prosthesis use and predicts outcome acceptance following upper limb loss. The investigators will also examine experiences with prosthesis education, selection, and training as well as how psychological and social issues impact prosthesis use. In addition, the investigators will use the findings to develop a prototype decision tool to assist with matching persons to prostheses. Study findings will help providers, technology developers, and researchers better understand the complex experience of upper limb prosthesis use. This conceptual framework will enable clinicians and researchers to evaluate and predict patient outcomes following limb loss, and to design interventions that improve outcomes. The proposed study is a mixed methods (qualitative and quantitative) study using an observational design. The qualitative component of the study will involve data collection through telephone interviews with 42 participants and analyses using a grounded theory approach with constant comparison methods. The quantitative component involves administration of standardized measures quantifying constructs of the theoretical model in 120 participants and analyses to produce a structural equation model of outcome acceptance. Participants will include persons with unilateral acquired upper limb loss at the trans radial or trans humeral level who use currently available prosthetic devices. Up to 16 individuals will participate in a series of focus groups that will be conducted to provide feedback on the model generated from previous data.

Interventions

  • OTHER Qualitative Analysis

Study Locations (1)

Ohio

  • Louis Stokes VA Medical Center - Cleveland

Trial Details

FieldValue
Enrollment Target 178 participants
Start Date 2020-12-16
Est. Completion 2026-09-30

Sponsor

Louis Stokes VA Medical Center

10 total trials

What the Registry Record Tells You About NCT04855214

The ClinicalTrials.gov registry entry for NCT04855214 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 178 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 130-participant average among 65 other Amputation trials with a reported enrollment target (37% higher). The listed sponsor is Louis Stokes VA Medical Center, which has 10 total studies on file at ClinicalTrials.gov.

The record links to 5 conditions, with Amputation appearing as the primary indexed condition, and to 1 intervention - of which Qualitative Analysis is the first listed.

NCT04855214 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.

Frequently Asked Questions

What is clinical trial NCT04855214 about?

NCT04855214 is a clinical study titled "Evaluating the Experience of Upper Limb Prosthesis Use". The goal is to understand the critical factors associated with outcome acceptance following upper limb loss. The investigators aim to develop a unified theoretical model that describes the psychosocial experience of upper limb prosthesis use and predicts outcome acceptance following upper limb loss....

What is the current status of trial NCT04855214?

This trial is currently recruiting. The enrollment target is 178 participants. The study started on 2020-12-16. Estimated completion is 2026-09-30.

What conditions does trial NCT04855214 study?

This clinical trial studies the following conditions: Amputation, Prosthesis User, Upper Limb Amputation Below Elbow (Injury), Upper Limb Amputation at the Wrist, Upper Limb Amputation Above Elbow (Injury).

What interventions are being tested in trial NCT04855214?

The interventions under investigation include: Qualitative Analysis (OTHER).

Who is sponsoring clinical trial NCT04855214?

This trial is sponsored by Louis Stokes VA Medical Center, which has 10 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04855214 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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