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OpenTrials
Completed

NCT Number: NCT02749643

Functional Outcome Measures With Vibrotactile Feedback to Prostheses

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hadassah Medical Center

Jerusalem, 91240, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vibrotactile feedback system

Device

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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".

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Collaborators

  • Tel Aviv University

Registry information

Official study title

The Effects of Adding Vibrotactile Feedback to Prostheses on Functional Outcome Measures of Transradial Amputation Prosthetic Users

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 25, 2016
Registry last updated
Jun 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.