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

NCT06684730 | Recruiting

• 1 other identifier: E-34215015-771-250527790
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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. 1.Are there differences in patient satisfaction, quality of life, and hand function between individuals using standard myoelectric and bionic hand prostheses?
2. 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. 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. 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?

Conditions

Transradial Amputation; Wrist Disarticulation

Keywords

Standard Myoelectric Hand; Transradial Amputation; Bionic Hand; Wrist disarticulation; Amputation of upper limb

Outcome Measures

Primary Outcomes (1)

• Kinematical measurement of shoulder abduction

  Kinovea, a free and reliable 2D motion analysis software, will be used to collect kinematic data during simulated tasks of pouring water from a pitcher into a glass and drinking water from an empty glass. Kinovea provides acceptable accuracy in angular and linear measurements obtained by digitizing x and y coordinates. In the study, two synchronized cameras will be positioned 150 cm away from the patient, anteriorly and laterally, to capture the lumbar region and more proximal segments. Markers will be placed on the lateral epicondyle and fossa cubitalis of the elbow, and on the anterior and lateral aspects of the glenohumeral joint. Shoulder abduction kinematics will be assessed.

  immediately before/after the parkour

Secondary Outcomes (9)

• Defined parkour completion time

  From the start of the parkour to the completion of the parkour (about 12 minutes)

• The Box and Blocks Test (BBT)

  "Immediately before/after parkour

• Action Research Arm Test (ARAT)

  Immediately before/after parkour

• Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)

  Immediately before/after parkour

• Kinematic measurement of elbow flexion

  Immediately before/after parkour

Study Arms (2)

Individuals with transradial amputees or wrist disarticulation using standard myoelectric hands

Procedure: Hand Function Assessment Scales; Other: Prosthesis Satisfaction Scale; Other: Quality of Life Scale; Procedure: Kinematic Analysis; Procedure: Parkour Completion Time; Procedure: Fatigue Scale

Individuals with transradial amputees or wrist disarticulation using bionic hand

Procedure: Hand Function Assessment Scales; Other: Prosthesis Satisfaction Scale; Other: Quality of Life Scale; Procedure: Kinematic Analysis; Procedure: Parkour Completion Time; Procedure: Fatigue Scale

Interventions

Hand Function Assessment Scales PROCEDURE

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.

Individuals with transradial amputees or wrist disarticulation using bionic hand; Individuals with transradial amputees or wrist disarticulation using standard myoelectric hands

Prosthesis Satisfaction Scale OTHER

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

Individuals with transradial amputees or wrist disarticulation using bionic hand; Individuals with transradial amputees or wrist disarticulation using standard myoelectric hands

Quality of Life Scale OTHER

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

Individuals with transradial amputees or wrist disarticulation using bionic hand; Individuals with transradial amputees or wrist disarticulation using standard myoelectric hands

Kinematic Analysis PROCEDURE

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.

Individuals with transradial amputees or wrist disarticulation using bionic hand; Individuals with transradial amputees or wrist disarticulation using standard myoelectric hands

Parkour Completion Time PROCEDURE

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.

Individuals with transradial amputees or wrist disarticulation using bionic hand; Individuals with transradial amputees or wrist disarticulation using standard myoelectric hands

Fatigue Scale PROCEDURE

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.

Individuals with transradial amputees or wrist disarticulation using bionic hand; Individuals with transradial amputees or wrist disarticulation using standard myoelectric hands

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Twenty-two participants with transradial amputation or wrist disarticulation will be enrolled in the study. These participants will be recruited from the Veterans Physical Therapy and Rehabilitation Training and Research Hospital and will consist of 11 individuals using bionic hand prostheses and 11 using standard myoelectric hand prostheses.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

Study Sites (1)

Gaziler Physical Therapy and Rehabilitation Training and Research Hospital

Ankara, ÇANKAYA, 06100, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Major MJ, Stine RL, Heckathorne CW, Fatone S, Gard SA. Comparison of range-of-motion and variability in upper body movements between transradial prosthesis users and able-bodied controls when executing goal-oriented tasks. J Neuroeng Rehabil. 2014 Sep 6;11:132. doi: 10.1186/1743-0003-11-132.

  PMID: 25192744 BACKGROUND

• Carey SL, Dubey RV, Bauer GS, Highsmith MJ. Kinematic comparison of myoelectric and body powered prostheses while performing common activities. Prosthet Orthot Int. 2009 Jun;33(2):179-86. doi: 10.1080/03093640802613229.

  PMID: 19367522 BACKGROUND

• Kerver N, Schuurmans V, van der Sluis CK, Bongers RM. The multi-grip and standard myoelectric hand prosthesis compared: does the multi-grip hand live up to its promise? J Neuroeng Rehabil. 2023 Feb 15;20(1):22. doi: 10.1186/s12984-023-01131-w.

  PMID: 36793049 BACKGROUND

Central Study Contacts

Nurdan KORKMAZ, MD

CONTACT

+903122912410; nurizkorkmaz@hotmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Medicine and Rehabilitation Associate Professor

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 12, 2024
• Study Start: November 27, 2024
• Primary Completion: March 1, 2026
• Study Completion: April 29, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)