Functional Outcome Measures With Vibrotactile Feedback to Prostheses

Not Applicable

Completed

• Conditions: Unilateral Transradial Amputation
• Interventions: Device: Vibrotactile feedback system

• Registration Number: NCT02749643
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

Investigators wish to evaluate the effects of adding VTF to upper limb prostheses on functional outcome measures of upper limb prosthetic users.

Detailed Description

Investigators will perform three experiments:

1. 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;

2. 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

3. 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 Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-13
• Study First Submitted QC: 2016-04-22
• Study First Posted: 2016-04-25
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-25
• Last Update Posted: 2018-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Unilateral transradial amputee
• Using a transradial myoelectric prosthesis
• Ability to follow simple instructions, understand and sign an informed consent form
• Normal or corrected eyesight

Exclusion Criteria

• Elbow or wrist disarticulation or partial hand amputations
• Neuropathy or skin ulcers on the amputated limb

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vibrotactile feedback	Vibrotactile feedback system	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.

Primary Outcome Measures

Name	Time	Method
Orthotics and Prosthetics User Survey-Upper Extremity Functional Status	2 weeks	A subjective questionnaire concerning the ability to perform daily tasks. The score ranges from 23 to 115.

Secondary Outcome Measures

Name	Time	Method
Time to complete dual tasking test	2 weeks	The time needed to complete grasping tasks while playing a simple computer game with the other hand is measured in seconds.
Modified Box & Blocks test	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.
Activity	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".

Trial Locations

Locations (1)

Hadassah Medical Center; 🇮🇱 Jerusalem, Israel