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Transradial AmputationNCT06684730

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

An observational study of Transradial Amputation and Wrist Disarticulation, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Transradial Amputation, Wrist Disarticulation
What is being tested?
Hand Function Assessment Scales, Prosthesis Satisfaction Scale and Quality of Life Scale
Type of treatment
Surgery or procedure
How many people
22 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Dec 2024to 1 Jun 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Gaziler Physical Therapy and Rehabilitation Training and Research Hospital

    Ankara, ÇANKAYA, 06100

Other trials in Turkey (Türkiye)

About this study

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?
Read the 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.

Being tested
Hand Function Assessment Scales, Prosthesis Satisfaction Scale, Quality of Life Scale, Kinematic Analysis, Parkour Completion Time
Keywords
Standard Myoelectric Hand, Transradial Amputation, Bionic Hand, Wrist disarticulation, Amputation of upper limb

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hand Function Assessment ScalesProcedure or 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 ScaleOther

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

  • Quality of Life ScaleOther

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

  • Kinematic AnalysisProcedure or 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 TimeProcedure or 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 ScaleProcedure or 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.

Study groups in NCT06684730
Study groupRoleWhat they receive
Individuals with transradial amputees or wrist disarticulation using standard myoelectric handsNot described
Receives: 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 handNot described
Receives: Procedure: Hand Function Assessment Scales; Other: Prosthesis Satisfaction Scale; Other: Quality of Life Scale; Procedure: Kinematic Analysis; Procedure: Parkour Completion Time; Procedure: Fatigue Scale

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: immediately before/after the parkour

Secondary outcomes (9)
  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.

    Measured: 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.

    Measured: "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.

    Measured: 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.

    Measured: Immediately before/after parkour

  5. Kinematic measurement of elbow flexion

    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.

    Measured: Immediately before/after parkour

  6. Kinematic measurement of cervical flexion

    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.

    Measured: Immediately before/after parkour

  7. 5Q-5D-5L

    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.

    Measured: Baseline

  8. The Quebec Assistive Technology User Satisfaction Assessment (Q-YTKMD) Questionnaire

    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.

    Measured: Baseline

  9. Fatigue Assessment Scale

    It is a 5-point Likert scale ranging from 0 (not tired at all) to 5 (very tired).

    Measured: Immediately before/after parkour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2024
  2. Study start1 Dec 2024
  3. Primary completion28 Feb 2026
  4. Study completion1 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06684730
Sponsor's protocol ID
E-34215015-771-250527790
Status last verified
Sep 2026
First submitted
7 Nov 2024
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 25192744
  • 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.

    PubMed 19367522
  • 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.

    PubMed 36793049

Questions about this trial

What is this clinical trial studying?

An observational study of Transradial Amputation and Wrist Disarticulation, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Kinematical measurement of shoulder abduction (time frame: immediately before/after the parkour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06684730, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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