Comparison of Standard Myoelectric Hand and Bionic Hand Use in Individuals With Upper Limb Amputation
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:
- Are there differences in patient satisfaction, quality of life, and hand function between individuals using standard myoelectric and bionic hand prostheses?
- 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?
- 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?
- 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?
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: Nurdan KORKMAZ, MD
- Phone Number: +903122912410
- Email: nurizkorkmaz@hotmail.com
Study Locations
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ÇANKAYA
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Ankara, ÇANKAYA, Turkey (Türkiye), 06100
- Gaziler Physical Therapy and Rehabilitation Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Individuals with transradial amputees or wrist disarticulation using standard myoelectric hands
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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.
The Quebec Assistive Technology User Satisfaction Assessment (Q-YTKMD) Questionnaire will be used.
5Q-5D-5L will be used as quality of life scale.
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.
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.
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.
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Individuals with transradial amputees or wrist disarticulation using bionic hand
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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.
The Quebec Assistive Technology User Satisfaction Assessment (Q-YTKMD) Questionnaire will be used.
5Q-5D-5L will be used as quality of life scale.
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.
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.
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.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Kinematical measurement of shoulder abduction
Time Frame: immediately before/after the parkour
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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.
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immediately before/after the parkour
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Defined parkour completion time
Time Frame: From the start of the parkour to the completion of the parkour (about 12 minutes)
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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.
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From the start of the parkour to the completion of the parkour (about 12 minutes)
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The Box and Blocks Test (BBT)
Time Frame: "Immediately before/after parkour
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The Box and Blocks Test (BBT) is a standardized assessment of unimanual dexterity.
It involves transferring 150 cubic wooden blocks, one at a time, from one compartment of a divided wooden box to the other within a one-minute time limit.
The test score is determined by the total number of blocks transferred, with higher scores indicating greater dexterity.
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"Immediately before/after parkour
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Action Research Arm Test (ARAT)
Time Frame: Immediately before/after parkour
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The Action Research Arm Test (ARAT) is a standardized 19-item assessment designed to evaluate upper limb function.
Tasks are hierarchically arranged from complex to simple and are categorized into four subscales: gross grasp, fine grasp, pinch, and gross movement.
A 4-point ordinal scale, ranging from 0 (no movement) to 3 (normal movement), is used to score each item.
Total scores range from 0 to 57, with higher scores indicating better upper limb function.
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Immediately before/after parkour
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Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)
Time Frame: Immediately before/after parkour
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This is a commonly used 30-item outcome assessment tool designed to quantify the physical, psychological, and social role function in individuals experiencing upper extremity dysfunction.
The questionnaire employs a 5-point Likert scale for scoring, where a higher score signifies a more pronounced level of disability.
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Immediately before/after parkour
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Kinematic measurement of elbow flexion
Time Frame: Immediately before/after parkour
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Kinovea software will be used during simulated tasks of pouring water from a pitcher into a glass and drinking water from an empty glass.
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, anteriorly and laterally on the glenohumeral joint, and on the dorsal aspect of the hand.
Elbow flexion kinematics will be evaluated.
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Immediately before/after parkour
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Kinematic measurement of cervical flexion
Time Frame: Immediately before/after parkour
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Kinovea software will be used during simulated tasks of pouring water from a pitcher into a glass and drinking water from an empty glass.
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 C7 vertebra and the occiput.
Cervical flexion kinematics will be evaluated.
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Immediately before/after parkour
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5Q-5D-5L
Time Frame: Baseline
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The 5Q-5D-5L is a generic quality of life scale.
The scale is divided into two sections.
The first section assesses the daily health profile in five sub-dimensions: movement, self-care, usual activities, pain/discomfort, and anxiety/depression.
Respondents rate each sub-dimension on a 5-point Likert scale ranging from "no problem" to "extreme problem".
In the second section, participants rate their current health status on a 0-100 scale, marking their response on a thermometer-like scale.
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Baseline
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The Quebec Assistive Technology User Satisfaction Assessment (Q-YTKMD) Questionnaire
Time Frame: Baseline
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The Q-YTKMD questionnaire is a standardized tool commonly used to evaluate the satisfaction of individuals using a variety of assistive technologies.
It comprises 12 items, specifically addressing satisfaction with the assistive device (8 items) and the service provided (4 items).
Scores range between 12 and 60, with higher scores reflecting greater levels of satisfaction.
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Baseline
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Fatigue Assessment Scale
Time Frame: Immediately before/after parkour
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It is a 5-point Likert scale ranging from 0 (not tired at all) to 5 (very tired).
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Immediately before/after parkour
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Collaborators and Investigators
Sponsor
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
Other Study ID Numbers
- E-34215015-771-250527790
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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