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The Relationship Between Lost Extremity Percentage and Postural Control, Neck and Low Back Pain, Daily Living Activities, and Reaction Time in Individuals With Unilateral Upper Limb Amputation

30. juni 2026 opdateret af: Asli Bebek, Hacettepe University

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

15

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

N/A

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Andet: This is an observational study. No interventional procedures are performed. All assessments are non-invasive measurements.
This is an observational study. No interventional procedures are performed. All assessments are non-invasive measurements.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Daily living activity score
Tidsramme: through study completion, an average of 1 year
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postural Sway and Limits of Stability
Tidsramme: through study completion, an average of 1 year
Postural sway (cm) measured using a force BERTEC platform system.
through study completion, an average of 1 year
Postural Sway and Limits of Stability
Tidsramme: through study completion, an average of 1 year
limits of stability (%) measured using a force BERTEC platform system.
through study completion, an average of 1 year
Neck and Back Pain Intensity
Tidsramme: through study completion, an average of 1 year
Measured using the Visual Analog Scale (VAS) on a 0-10 scale, where 0 indicates no pain and 10 indicates the worst possible pain.
through study completion, an average of 1 year
Hand Dexterity
Tidsramme: through study completion, an average of 1 year
easured using the Box and Block Test (number of blocks successfully transferred from one compartment to another in 60 seconds).
through study completion, an average of 1 year
Reaction Time
Tidsramme: through study completion, an average of 1 year
Measured using the BlazePod system (recorded in milliseconds and the number of correct responses in 30 seconds).
through study completion, an average of 1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hacettepe University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2026

Primær færdiggørelse (Anslået)

1. august 2026

Studieafslutning (Anslået)

1. december 2026

Datoer for studieregistrering

Først indsendt

14. februar 2026

Først indsendt, der opfyldte QC-kriterier

30. juni 2026

Først opslået (Faktiske)

1. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FTREK25/28

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

. 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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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