NCT07347561

Brief Summary

This observational study aims to compare myoelectric and bionic hands in terms of upper extremity function, body image and satisfaction. The main questions it aims to answer are: \- Does upper extremity function differ between bionic and myoelectric hands? The main questions it aims to answer are: Does upper extremity function differ between bionic and myoelectric hands?

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2026

Completed
Last Updated

January 16, 2026

Status Verified

November 1, 2025

Enrollment Period

4 months

First QC Date

January 9, 2026

Last Update Submit

January 9, 2026

Conditions

Keywords

Amputationbionic handmyoelectric handprosthesistrans-humeraltrnas-radial

Outcome Measures

Primary Outcomes (3)

  • Upper Limb Functionol Index-15

    The Upper Limb Functional Index-15 (ULFI-15) is a 15-item patient-reported outcome measure used to assess functional limitations related to the upper extremity. It evaluates difficulties in daily activities, movement, and functional performance of the upper limb. Higher scores indicate greater functional limitation.

    Baseline

  • Amputee Body Image Scale

    The Amputee Body Image Scale (ABIS) is a self-reported questionnaire designed to assess body image perception and body-related concerns in individuals with limb amputation. It measures the psychological impact of amputation on body image, with higher scores reflecting greater body image disturbance.

    Baseline

  • Orthotics and Prosthetics Users' Survey

    The Orthotics and Prosthetics Users' Survey (OPUS) is a validated patient-reported outcome measure used to evaluate functional status, satisfaction, and quality of life in individuals using orthotic or prosthetic devices. It assesses the user's perceived functional ability and satisfaction with their prosthetic device and related services.

    Baseline

Study Arms (2)

Bionic Prosthetic Hand Group

Participants use advanced myoelectric prosthetic hands with multi-articulating structures and enhanced control features designed to improve functional performance.These devices are designed to enhance hand function, dexterity, and user interaction beyond conventional myoelectric control.

Myoelectric Prosthetic Hand Group

Participants in this group are individuals with upper limb amputation who use a myoelectric prosthetic hand controlled by surface electromyographic signals from residual limb muscles. These devices provide electrically powered hand movement and basic grasp functions without advanced bionic or sensor-integrated features.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study included individuals aged 8-65 who had undergone upper limb amputation.

You may qualify if:

  • Aged 18 to 65 years
  • Individuals with unilateral upper limb amputation
  • Regular use of a prosthetic device for at least 6 months
  • Use of a semi-electronic elbow joint prosthetic component
  • Ability to understand and complete study assessments

You may not qualify if:

  • Presence of bilateral or multiple limb amputations
  • Proximal upper limb amputation at the shoulder level or above
  • Coexisting neurological or orthopedic disorders that may affect upper limb function or study outcomes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences Gülhane Faculty of Health Sciences

Ankara, Keçiören, 06010, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • Carey SL, Lura DJ, Highsmith MJ; CP; FAAOP. Differences in myoelectric and body-powered upper-limb prostheses: Systematic literature review. J Rehabil Res Dev. 2015;52(3):247-62. doi: 10.1682/JRRD.2014.08.0192.

  • Kannenberg, A., Lundstrom, R., Hibler, K. D., & Johnson, S. S. (2023). Differences in two multiarticulating myoelectric hands for facilitating activities of daily living in individuals with transradial amputation: a cross-sectional study. JPO: Journal of Prosthetics and Orthotics, 35(1), 38-43.

    RESULT

Central Study Contacts

Güllü AYDIN YAĞCIOĞLU, Asst. Prof

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof

Study Record Dates

First Submitted

January 9, 2026

First Posted

January 16, 2026

Study Start

November 1, 2025

Primary Completion

February 15, 2026

Study Completion

March 15, 2026

Last Updated

January 16, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations