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

NCT ID: NCT06684730

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 22 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-27
• Study Completion Date: 2026-01-29

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. 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?

Detailed Description

Amputation constitutes a major trauma that substantially affects an individual's functional status and activities of daily living. The functional impairments ensuing from amputation can impede reintegration into normal life, giving rise to social, occupational, and psychological challenges. Amputees frequently encounter significant limitations in activities and participation. These limitations are predominantly related to mobility and self-care. These factors adversely affect the ability to return to work and maintain employment, continue social relationships, engage in leisure pursuits, and be active in community life. A variety of prostheses are employed to restore the functions of an amputated limb and achieve bodily integrity. Individuals with upper limb amputations may utilize cosmetic (passive), body-powered (mechanical, cable-activated), myoelectric, or hybrid prostheses. Myoelectric prostheses are controlled by electromyography (EMG) signals and are powered by rechargeable motors to execute movements. Successful prosthesis use necessitates the individual's physical capacity to operate the device and sufficient cognitive awareness to comprehend and control it. Two prevalent hand types in myoelectric upper limb prostheses are the standard myoelectric hand and the bionic hand. The standard myoelectric hand employs a single motor to provide a robust and consistent tripod grasp. The motor actuates the opening and closing of the first, second, and third digits. The fourth and fifth digits passively follow the others. Bionic hands, in contrast, feature multiple joints in each finger, enabling more natural finger movements, and some models incorporate multiple motors for independent finger control. This expands the range of functional grasp patterns. Instead of a single tripod grasp, they offer various grasp patterns (pinch, trigger, lateral, cylindrical, spherical, hook, key grasp, etc.). While providing users with greater hand dexterity, this increased grasp versatility comes with drawbacks such as higher cost and reduced durability. Moreover, the sequential nature of grasp movements, the necessity for patients to memorize this sequence, and the need to switch modes between grasps (open, dual, triple, co-contraction, button) can pose usability challenges. Consequently, executing a hand function using these grasps can be time-consuming, cognitively demanding, and physically exhausting. Despite over a decade of use, the existing literature on the advantages and disadvantages of bionic hand prostheses is limited and the findings are not entirely compelling. Additionally, these few studies predominantly rely on user reports. Individuals with upper limb amputation who use prostheses demonstrate unnatural or unusual movements in other joints and body regions. To successfully perform activities of daily living and tasks, they adapt the movement of their remaining limbs and develop compensatory movements. As the prosthesis's functionality approaches that of a healthy hand, compensatory movements also diminish. Studies have shown that during the use of upper limb prostheses, shoulder and trunk joint angles are increased compared to healthy individuals, elbow range of motion is limited, and decreased elbow movement is compensated for by increasing shoulder abduction or cervical spine flexion. These compensatory movements result in cognitive and physical fatigue in amputees. This situation is considered one of the factors influencing the discontinuation of prosthesis use. While the literature suggests that the use of bionic hands may reduce these compensatory movements, only one study has compared these angles in individuals using standard myoelectric hands and bionic hands. To our knowledge, there is no study that comprehensively compares quality of life, prosthesis satisfaction, kinematic measurement of compensatory elbow, shoulder, and cervical movements, time-consuming of hand functions, and the degree of fatigue in individuals with upper limb amputation who use bionic or standard myoelectric hands. This study aims to address this gap in the literature, evaluate the functionality of prostheses more objectively by combining various outcome measures, and to pioneer new studies.

Conditions

Transradial Amputation; Wrist Disarticulation

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Individuals with transradial amputees or wrist disarticulation using standard myoelectric hands

Hand Function Assessment Scales

Intervention Type: 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.

Prosthesis Satisfaction Scale

Intervention Type: OTHER

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

Quality of Life Scale

Intervention Type: OTHER

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

Kinematic Analysis

Intervention Type: 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.

Parkour Completion Time

Intervention Type: 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.

Fatigue Scale

Intervention Type: 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

Hand Function Assessment Scales

Intervention Type: 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.

Prosthesis Satisfaction Scale

Intervention Type: OTHER

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

Quality of Life Scale

Intervention Type: OTHER

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

Kinematic Analysis

Intervention Type: 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.

Parkour Completion Time

Intervention Type: 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.

Fatigue Scale

Intervention Type: 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.

Interventions

Hand 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.

Intervention Type: PROCEDURE

Prosthesis Satisfaction Scale

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

Intervention Type: OTHER

Quality of Life Scale

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

Intervention Type: OTHER

Kinematic 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.

Intervention Type: PROCEDURE

Parkour 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.

Intervention Type: PROCEDURE

Fatigue 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nurdan Korkmaz

Physical Medicine and Rehabilitation Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gaziler Physical Therapy and Rehabilitation Training and Research Hospital

Ankara, Çankaya, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Nurdan KORKMAZ, MD

Role: CONTACT

nurizkorkmaz@hotmail.com

+903122912410

Facility Contacts

Nurdan KORKMAZ, MD

Role: primary

nurizkorkmaz@hotmail.com

+903122912410

References

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.

Reference Type: BACKGROUND

PMID: 25192744 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19367522 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36793049 (View on PubMed)

Other Identifiers

E-34215015-771-250527790

Identifier Type: -

Identifier Source: org_study_id