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Functional Outcome Measures With Vibrotactile Feedback to Prostheses

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02749643
Enrollment
10
Registered
2016-04-25
Start date
2016-04-30
Completion date
2018-02-28
Last updated
2018-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unilateral Transradial Amputation

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.

Interventions

DEVICEVibrotactile feedback system

Sponsors

Tel Aviv University
CollaboratorOTHER
Hadassah Medical Organization
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Orthotics and Prosthetics User Survey-Upper Extremity Functional Status2 weeksA subjective questionnaire concerning the ability to perform daily tasks. The score ranges from 23 to 115.

Secondary

MeasureTime frameDescription
Modified Box & Blocks test2 weeksThis 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.
Time to complete dual tasking test2 weeksThe time needed to complete grasping tasks while playing a simple computer game with the other hand is measured in seconds.
Activity2 weeksIn 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.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026