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

Amputation Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05261178
• Other study ID #: 27
• Status: Not yet recruiting
• Start date: October 1, 2022
• Est. completion date: October 1, 2022

Study information

• Verified date: February 2022
• Source: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• Contact: Fatma Özcan, MD
• Phone: 05078689545
• Email: fatma_yumus[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: October 1, 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Amputation

Intervention

Other:
• Evaluation of satisfaction and the level of daily living activities using the prosthesis
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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trinity Amputation and Prosthesis Experience Scale	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
Primary	SF-36 (Short Form-36)	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