Functional Outcome Measures With Vibrotactile Feedback to Prostheses

Unilateral Transradial Amputation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02749643
• Other study ID #: VTF- HMO-CTIL
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: February 2018

Study information

• Verified date: June 2018
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Unilateral Transradial Amputation

Intervention

Device:
• Vibrotactile feedback system

Locations

Country	Name	City	State
Israel	Hadassah Medical Center	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
Hadassah Medical Organization	Tel Aviv University

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Clemente F, D'Alonzo M, Controzzi M, Edin BB, Cipriani C. Non-Invasive, Temporally Discrete Feedback of Object Contact and Release Improves Grasp Control of Closed-Loop Myoelectric Transradial Prostheses. IEEE Trans Neural Syst Rehabil Eng. 2016 Dec;24(12 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 weeks
Secondary	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.	2 weeks
Secondary	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.	2 weeks
Secondary	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".	2 weeks