- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05261178
Evaluation of Satisfaction and Effect on Daily Living Activities With the Use of Myoelectric Controlled Prosthesis
29. september 2022 opdateret af: Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Evaluation of Satisfaction With the Use of Myoelectric Controlled Prosthesis and Its Effect on Daily Living Activities in Patients With Upper Extremity Amputation
Myoelectrically controlled arm prostheses are often offered to individuals with upper extremity limb loss in order to restore body balance and compensate for the lack of grasping ability during the rehabilitation process.
Myoelectrically controlled prostheses utilize the presence of two independent signals from a set of agonist and antagonist muscles.
However, individuals with upper extremity amputation may not want to use their prosthesis.
One of the reasons for not wanting to use the prosthesis is prosthesis dissatisfaction.
This study aims to evaluate prosthesis satisfaction and the effect of prosthesis use on daily living activities of upper extremity amputees using myoelectric controlled prosthesis.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The study will be carried out with patients who applied to the outpatient clinic or who received inpatient treatment in the orthopedic rehabilitation (amputee) clinic.
The patient's demographic information (age, gender, height, weight, body mass index, education level, occupation, marital status) and clinical characteristics (amputation date, cause of injury, amputation side, etc.) will be recorded with the evaluation to be made to the patient.
Patients' satisfaction with using their prosthesis will be evaluated with TAPES (Trinity Amputation and Prosthesis Experience Scale) and daily living activities using their prosthesis with SF-36 (Short Form-36).
Undersøgelsestype
Observationel
Tilmelding (Forventet)
20
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Fatma Özcan, MD
- Telefonnummer: 05078689545
- E-mail: fatma_yumus@hotmail.com
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
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
20 patients aged 18-65 years with upper extremity amputation and using myoelectric controlled arm prosthesis for at least 3 months
Beskrivelse
Inclusion Criteria:
- Being between the ages of 18-65
- Having an upper extremity amputation
- Using myoelectric controlled arm prosthesis for at least 3 months
Exclusion Criteria:
- Being under the age of 18
- Having significant cognitive or hearing impairment that would preclude participation in research
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 |
|---|---|
|
Upper extremity amputation patients using myoelectric controlled prosthesis
20 patients aged 18-65 years with upper extremity amputation and using myoelectric controlled arm prosthesis for at least 3 months
|
Evaluation of satisfaction with using the prosthesis with TAPES (Trinity Amputation and Prosthesis Experience Scale) and the level of daily living activities using the prosthesis with SF-36 (Short Form-36)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Trinity Amputation and Prosthesis Experience Scale
Tidsramme: Through study completion, an average of one and a half months
|
It consists of two parts after the first part, which includes demographic and disability-related information.
Part I covers psychosocial adjustment, activity restriction, and satisfaction with the prosthesis.
In the second part, there are questions about how many hours a day the prosthesis is worn on average, general health status and physical capacity.
The scores are summed up with a subscale score between 10 and 50.
Higher scores correspond to satisfaction with the prothesis.
|
Through study completion, an average of one and a half months
|
|
SF-36 (Short Form-36)
Tidsramme: Through study completion, an average of one and a half months
|
It consists of eight scales (general health, physical function, physical role, emotional role, social function, pain, energy, mental health), each varying between 2-10 questions, and a health course question that is not included in the scoring.
Each question is scored on only one scale.
Scoring is made between 0-100 for each scale.
The lowest score represents the worst health condition.
|
Through study completion, an average of one and a half months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Fatma Özcan, MD, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
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 (Forventet)
1. oktober 2022
Primær færdiggørelse (Forventet)
1. oktober 2022
Studieafslutning (Forventet)
1. oktober 2022
Datoer for studieregistrering
Først indsendt
19. februar 2022
Først indsendt, der opfyldte QC-kriterier
19. februar 2022
Først opslået (Faktiske)
2. marts 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. september 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. september 2022
Sidst verificeret
1. februar 2022
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 27
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
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Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .