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Clinical Trials/NCT02749643
NCT02749643
Completed
N/A

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

Hadassah Medical Organization1 site in 1 country10 target enrollmentApril 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Unilateral Transradial Amputation
Sponsor
Hadassah Medical Organization
Enrollment
10
Locations
1
Primary Endpoint
Orthotics and Prosthetics User Survey-Upper Extremity Functional Status
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
February 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Isabella Shvartz

Director, clinical research

Hadassah Medical Organization

Eligibility 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

Outcomes

Primary Outcomes

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

  • Time to complete dual tasking test(2 weeks)
  • Modified Box & Blocks test(2 weeks)
  • Activity(2 weeks)

Study Sites (1)

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