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Functional Outcome Measures With Vibrotactile Feedback to Prostheses

H

Hadassah Medical Center

Status

Completed

Conditions

Unilateral Transradial Amputation

Treatments

Device: Vibrotactile feedback system

Study type

Interventional

Funder types

Other

Identifiers

NCT02749643
VTF- HMO-CTIL

Details and patient eligibility

About

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

Full 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.

Enrollment

10 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Vibrotactile feedback
Experimental group
Description:
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.
Treatment:
Device: Vibrotactile feedback system

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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