Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Observationell

Inskrivning (Beräknad)

15

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

N/A

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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.
Övrig: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Daily living activity score
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Postural Sway and Limits of Stability
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Hacettepe University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 januari 2026

Primärt slutförande (Beräknad)

1 augusti 2026

Avslutad studie (Beräknad)

1 december 2026

Studieregistreringsdatum

Först inskickad

14 februari 2026

Först inskickad som uppfyllde QC-kriterierna

30 juni 2026

Första postat (Faktisk)

1 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • FTREK25/28

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

. 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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera