Functional Outcome Measures With Vibrotactile Feedback to Prostheses

Hadassah Medical Organization10 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Unilateral Transradial Amputation

Interventions

Vibrotactile feedback systemDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Hadassah Medical Center

Jerusalem, Israel

Outcomes

Primary Outcomes

Orthotics and Prosthetics User Survey-Upper Extremity Functional Status

A subjective questionnaire concerning the ability to perform daily tasks. The score ranges from 23 to 115.

Time frame: 2 weeks

Secondary Outcomes

Modified Box & Blocks test

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 frame: 2 weeks

Time to complete dual tasking test

The time needed to complete grasping tasks while playing a simple computer game with the other hand is measured in seconds.

Time frame: 2 weeks

Activity

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".

Time frame: 2 weeks

Data from ClinicalTrials.gov

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