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

Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05261178
Collaborator
(none)
20
7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Evaluation of satisfaction and the level of daily living activities using the 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 Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
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
Anticipated Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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

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)

Outcome Measures

Primary Outcome Measures

  1. TAPES (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. High scores indicate prosthesis satisfaction.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Investigators

  • Principal Investigator: Fatma Özcan, MD, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yasin Demir, Physical Medicine and Rehabilitation Specialist, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
ClinicalTrials.gov Identifier:
NCT05261178
Other Study ID Numbers:
  • 27
First Posted:
Mar 2, 2022
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yasin Demir, Physical Medicine and Rehabilitation Specialist, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Study Results

No Results Posted as of Mar 2, 2022