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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
Sponsor:
Collaborator:
Tel Aviv University
Information provided by (Responsible Party):
Isabella Shvartz, 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.

Condition or disease Intervention/treatment Phase
Unilateral Transradial Amputation Device: Vibrotactile feedback system Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs

Arm Intervention/treatment
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



Primary Outcome Measures :
  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 Outcome Measures :
  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".



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Israel
Hadassah Medical Center
Jerusalem, Israel, 91240
Sponsors and Collaborators
Hadassah Medical Organization
Tel Aviv University
Investigators
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Study Director: Sigal Portnoy, PhD Hadassah Medical Center
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Isabella Shvartz, Director, clinical research, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT02749643    
Other Study ID Numbers: VTF- HMO-CTIL
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided