NCT07677969

Brief Summary

This observational study aims to examine the relationship between the percentage of limb loss and functional outcomes in individuals with unilateral upper limb amputation. Upper limb amputation can affect posture, balance control, pain levels, daily living activities, hand function, and reaction time. However, limited research has investigated how the amount of limb loss influences these outcomes. Participants between 18 and 65 years of age who use a myoelectric or bionic prosthesis will undergo a series of assessments. These assessments include measurements of postural control using a force platform, posture analysis, evaluation of neck and low back pain using a visual analog scale, daily living activities using a validated questionnaire, hand dexterity using the Box and Block Test, and reaction time using a visual stimulus device. The study does not involve any intervention or treatment. All evaluations will be performed during a single assessment session. The results of this study may help improve rehabilitation planning and provide better understanding of functional changes associated with different levels of limb loss in people with upper limb amputation.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
4mo left

Started Jan 2026

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Jan 2026Dec 2026

Study Start

First participant enrolled

January 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 14, 2026

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 1, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

July 1, 2026

Status Verified

June 1, 2026

Enrollment Period

7 months

First QC Date

February 14, 2026

Last Update Submit

June 30, 2026

Conditions

Keywords

Upper Limb AmputationPostural ControlNeck Painlow back painDaily Living Activitiesreaction time

Outcome Measures

Primary Outcomes (1)

  • Daily living activity score

    In upper extremity amputees, daily living activities and occupational skills will be assessed using a questionnaire. (0-100 score, Survey on Activities of Daily Living and Occupations of Upper Extremity Amputees)

    through study completion, an average of 1 year

Secondary Outcomes (5)

  • Postural Sway and Limits of Stability

    through study completion, an average of 1 year

  • Postural Sway and Limits of Stability

    through study completion, an average of 1 year

  • Neck and Back Pain Intensity

    through study completion, an average of 1 year

  • Hand Dexterity

    through study completion, an average of 1 year

  • Reaction Time

    through study completion, an average of 1 year

Study Arms (1)

Unilateral Upper Limb Amputation Group

Participants in this cohort are adults aged 18 to 65 years with unilateral upper limb amputation who use a myoelectric or bionic prosthesis. Individuals must have been using their current prosthesis for at least three months and have a minimum of one year of prosthesis experience. Participants with additional neurological or orthopedic conditions, bilateral amputation, or passive/cosmetic prosthesis use are excluded. This is an observational study. No interventional procedures are performed. All participants undergo a single assessment session including measurements of postural control, posture, neck and low back pain, daily living activities, hand dexterity, and reaction time.

Other: This is an observational study. No interventional procedures are performed. All assessments are non-invasive measurements.

Interventions

This is an observational study. No interventional procedures are performed. All assessments are non-invasive measurements.

Unilateral Upper Limb Amputation Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study population consists of adults aged 18-65 years with unilateral upper limb amputation who use a myoelectric or bionic prosthesis. Participants are recruited from clinical and rehabilitation settings and meet predefined inclusion and exclusion criteria. All individuals undergo a single-session assessment to evaluate postural control, pain, daily living activities, hand function, and reaction time.

You may qualify if:

  • Adults aged 18-65 years
  • Unilateral upper limb amputation
  • Use of a myoelectric or bionic prosthesis for at least 1 year
  • Current prosthesis use for a minimum of 3 months

You may not qualify if:

  • Bilateral upper limb amputation
  • Additional amputation of another limb
  • Use of passive or cosmetic prosthesis
  • Presence of neurological or other significant orthopedic disorders unrelated to amputation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe university

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Neck PainLow Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBack Pain

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 14, 2026

First Posted

July 1, 2026

Study Start

January 1, 2026

Primary Completion

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

July 1, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

. The study includes sensitive clinical and functional assessment data collected at a single center. All data will be securely stored and used solely for research purposes in accordance with ethical approval and institutional regulations.

Locations