RecruitingNCT06684730

Comparison of Standard Myoelectric Hand and Bionic Hand Use in Individuals With Upper Limb Amputation


Sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Enrollment

22 participants

Start Date

Nov 27, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

This single-center, prospective, comparative study aims to compare hand function, quality of life, patient satisfaction, task completion time, fatigue, and compensatory elbow, shoulder, and cervical movements in individuals with transradial amputation or wrist disarticulation who use either standard myoelectric or bionic hand prostheses. The primary research questions are: 1. Are there differences in patient satisfaction, quality of life, and hand function between individuals using standard myoelectric and bionic hand prostheses? 2. Do individuals using standard myoelectric and bionic hand prostheses exhibit different kinematics in terms of compensatory shoulder, elbow, and neck movements? Could bionic hand prostheses with their diverse grasping capabilities lead to fewer compensatory movements compared to standard myoelectric hand prostheses? 3. Can fatigue induced by performing specific activities of daily living alter hand function and upper extremity-neck kinematics in individuals using either standard myoelectric or bionic hand prostheses? 4. Can cognitive and physical fatigue following activities of daily living lead to different levels of changes in hand function and upper extremity-neck kinematics in individuals using standard myoelectric and bionic hand prostheses?


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

  • Having a transradial amputation or wrist disarticulation due to acquired or congenital causes,
  • Using a standard myoelectric or bionic hand prosthesis for at least 6 months,
  • Being between the ages of 18 and 65,
  • Having no neurological or cognitive disorders, rheumatic diseases, or other upper extremity dysfunction that could affect test results, and
  • Having signed an informed consent form indicating the patient's willingness to participate in the study.

Exclusion Criteria4

  • Individuals younger than 18 or older than 65,
  • Those with additional musculoskeletal or neurological conditions preventing them from completing the tests and scales,
  • Those with psychiatric disorders or cognitive impairments preventing them from completing the questionnaire and assessment scales,
  • Those with stump or upper extremity conditions preventing them from using their prosthesis.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREHand Function Assessment Scales

The Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH), The Box and Block Test (BBT) and Action Research Arm Test (ARAT) will be used as hand function assessment scales.

OTHERProsthesis Satisfaction Scale

The Quebec Assistive Technology User Satisfaction Assessment (Q-YTKMD) Questionnaire will be used.

OTHERQuality of Life Scale

5Q-5D-5L will be used as quality of life scale.

PROCEDUREKinematic Analysis

Kinematic analysis of shoulder abduction, elbow flexion, and cervical flexion will be performed during simulated tasks of drinking water from a glass and filling glass of water.

PROCEDUREParkour Completion Time

A 10-item daily living activities parkour will be prepared for the participants. During the parkour, the participant will be given the following tasks: opening and closing 10 jar lids, slicing a 20cm cylindrical dough into 10 pieces, simulating drinking soup from a bowl 15 times with a spoon (standard bowl 150 ml, standard tablespoon 10 ml), simulating eating meatballs from a plate with a fork 10 times (approximately 6-10 meatballs per serving), simulating pouring water from a pitcher into a glass 10 times, simulating drinking water from a glass 10 times, simulating brushing teeth for 2 minutes, opening 10 clothespins attached to the edge of a cardboard box and attaching them to the other side, simulating opening and closing a zipper, and putting on shoes and tying shoelaces. The course completion time will be recorded.

PROCEDUREFatigue Scale

A pre- and post-parkour will be employed, including a 5-point Likert scale for fatigue assesment, hand function assessment scales and kinematic analysis to participants. The results before and after the parkour will be compared.


Locations(1)

Gaziler Physical Therapy and Rehabilitation Training and Research Hospital

Ankara, ÇANKAYA, Turkey (Türkiye)

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06684730