- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07677969
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
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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: ASLI BEBEK, MSc
- Numéro de téléphone: +905364037230
- E-mail: aslisabanci97@gmail.com
Lieux d'étude
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Ankara, Turquie (Türkiye)
- Recrutement
- Hacettepe University
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Contact:
- aslı bebek, MSc
- Numéro de téléphone: +905364037230
- E-mail: aslisabanci97@gmail.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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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. |
This is an observational study.
No interventional procedures are performed.
All assessments are non-invasive measurements.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Daily living activity score
Délai: through study completion, an average of 1 year
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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)
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through study completion, an average of 1 year
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Postural Sway and Limits of Stability
Délai: through study completion, an average of 1 year
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Postural sway (cm) measured using a force BERTEC platform system.
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through study completion, an average of 1 year
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Postural Sway and Limits of Stability
Délai: through study completion, an average of 1 year
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limits of stability (%) measured using a force BERTEC platform system.
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through study completion, an average of 1 year
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Neck and Back Pain Intensity
Délai: through study completion, an average of 1 year
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Measured using the Visual Analog Scale (VAS) on a 0-10 scale, where 0 indicates no pain and 10 indicates the worst possible pain.
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through study completion, an average of 1 year
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Hand Dexterity
Délai: through study completion, an average of 1 year
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easured using the Box and Block Test (number of blocks successfully transferred from one compartment to another in 60 seconds).
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through study completion, an average of 1 year
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Reaction Time
Délai: through study completion, an average of 1 year
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Measured using the BlazePod system (recorded in milliseconds and the number of correct responses in 30 seconds).
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through study completion, an average of 1 year
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- FTREK25/28
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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