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 volunteersQualifiers
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
Other
Prospective
Treatments tested in this trial
Hand Function Assessment Scales
Procedure/SurgeryThe 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 interventionThe Quebec Assistive Technology User Satisfaction Assessment (Q-YTKMD) Questionnaire will be used.
Quality of Life Scale
Other intervention5Q-5D-5L will be used as quality of life scale.
Kinematic Analysis
Procedure/SurgeryKinematic 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/SurgeryA 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/SurgeryA 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
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.