Functional Outcome Measures With Vibrotactile Feedback to Prostheses
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|ClinicalTrials.gov Identifier: NCT02749643|
Recruitment Status : Completed
First Posted : April 25, 2016
Last Update Posted : June 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Unilateral Transradial Amputation||Device: Vibrotactile feedback system||Not Applicable|
Investigators will perform three experiments:
- Investigators will add vibrotactile feedback to prosthetic users during the execution of a standardized functional test and performance of simple grasping tasks, with a disruption to the normal visual feedback, and examine whether their performance and arm kinematics are improved with tactile feedback;
- Investigators will examine the effects of adding the feedback to a prosthesis on the performance and visual attention during a dual task assignment in prosthetic users, and
- Investigators will provide prosthetic users with the feedback, to use it at their natural surroundings for a week, and study the reported activity and satisfaction levels.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effects of Adding Vibrotactile Feedback to Prostheses on Functional Outcome Measures of Transradial Amputation Prosthetic Users|
|Study Start Date :||April 2016|
|Actual Primary Completion Date :||February 2018|
|Actual Study Completion Date :||February 2018|
Experimental: Vibrotactile feedback
Vibrotactile system - comprises of force sensors, attached to the fingertips of the prosthetic hand, and a set of 8 vibration actuators attached to a fabric arm cuff. When the subject applies force on the sensors with his prosthetic hand, he receives a vibration on the skin of his arm. The sensors and actuators are connected to an electronic control board, which transforms the resistance from the sensors to an electric signal that activates the vibration actuators.
Device: Vibrotactile feedback system
- Orthotics and Prosthetics User Survey-Upper Extremity Functional Status [ Time Frame: 2 weeks ]A subjective questionnaire concerning the ability to perform daily tasks. The score ranges from 23 to 115.
- Modified Box & Blocks test [ Time Frame: 2 weeks ]This test is aimed to assess unilateral gross manual dexterity. The test comprises of a two-compartment box and 16 cube blocks.The subject is instructed to transport the blocks as possible over the partition into the opposite compartment. The time in seconds is measured.
- Time to complete dual tasking test [ Time Frame: 2 weeks ]The time needed to complete grasping tasks while playing a simple computer game with the other hand is measured in seconds.
- Activity [ Time Frame: 2 weeks ]In order to record the actual use of the prosthesis in the natural environment of the subject, a wireless activity monitor that can be easily attached to the prosthesis will be used. The output measure of the activity monitor are "activity counts".
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02749643
|Hadassah Medical Center|
|Jerusalem, Israel, 91240|
|Study Director:||Sigal Portnoy, PhD||Hadassah Medical Center|