Clinical trial NCT05261178: Evaluation of Satisfaction and Effect on Daily Living Activities With the Use of Myoelectric Controlled Prosthesis
Official title: Evaluation of Satisfaction With the Use of Myoelectric Controlled Prosthesis and Its Effect on Daily Living Activities in Patients With Upper Extremity Amputation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Amputation
Keywords: myoelectric controlled protheses
satisfaction
daily living activities
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 20 patients aged 18-65 years with upper extremity amputation and using myoelectric controlled arm prosthesis for at least 3 months

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

1. Being between the ages of 18-65
2. Having an upper extremity amputation
3. Using myoelectric controlled arm prosthesis for at least 3 months

Exclusion Criteria:

1. Being under the age of 18
2. Having significant cognitive or hearing impairment that would preclude participation in research

Primary outcomes:
measure: Trinity Amputation and Prosthesis Experience Scale
timeFrame: Through study completion, an average of one and a half months
measure: SF-36 (Short Form-36)
timeFrame: Through study completion, an average of one and a half months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
name: Fatma Özcan, MD
role: PRINCIPAL_INVESTIGATOR
References: