Evaluation of Satisfaction and Effect on Daily Living Activities With the Use of Myoelectric Controlled Prosthesis

• Conditions: Amputation
• Interventions: Other: Evaluation of satisfaction and the level of daily living activities using the prosthesis

• Registration Number: NCT05261178
• Lead Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

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).

Study Timeline

• Status Verified: 2022-02
• Study First Submitted: 2022-02-19
• Study First Submitted QC: 2022-02-19
• Study First Posted: 2022-03-02
• Last Update Submitted: 2022-09-29
• Last Update Posted: 2022-09-30
• Study Start: 2022-10-01
• Primary Completion: 2022-10
• Study Completion: 2022-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Upper extremity amputation patients using myoelectric controlled prosthesis	Evaluation of satisfaction and the level of daily living activities using the prosthesis	20 patients aged 18-65 years with upper extremity amputation and using myoelectric controlled arm prosthesis for at least 3 months

Primary Outcome Measures

Name	Time	Method
Trinity Amputation and Prosthesis Experience Scale	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.
SF-36 (Short Form-36)	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.