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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorGaziler Physical Medicine and Rehabilitation Education and Research Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial 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.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Hand Function Assessment Scales

    Procedure/Surgery

    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

    Other intervention

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

  • Quality of Life Scale

    Other intervention

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

  • Kinematic Analysis

    Procedure/Surgery

    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

    Procedure/Surgery

    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

    Procedure/Surgery

    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.

Treatment groups

22 Participants
are divided into 2 treatment groups
Group A: Individuals with transradial amputees or wrist disarticulation using standard myoelectric hands6 interventions
Group B: Individuals with transradial amputees or wrist disarticulation using bionic hand6 interventions

Trial outcomes

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.

Time frame
immediately before/after the parkour

Secondary outcomes

1

Defined 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.

Time frame
From the start of the parkour to the completion of the parkour (about 12 minutes)
2

The Box and Blocks Test (BBT)

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.

Time frame
"Immediately before/after parkour
3

Action Research Arm Test (ARAT)

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.

Time frame
Immediately before/after parkour
4

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

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.

Time frame
Immediately before/after parkour

Other outcomes

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