Using HandTutor With Traumatic Hand Injuries: Characterizing the System

April 12, 2018 updated by: Meir Medical Center

HandTutor is a computerized system designed to evaluate and rehabilitate hand function. It is composed of a glove with optic sensors detecting the movements of the wrist and the fingers with a biofeedback software designed to evaluate and then to exercise the hand movements through supplying a variety of computer graphic patterns.

The HandTutor has been used and tested with a stroke population, and it seems potential to be used with hand injuried population. As a first step, it is important to investigate the characteristics of the system and how it is matching the hand injuried population.

The purpose if this study is to characterize the HandTuror system and the focused objectives are:

  1. To examine the test-retest reliability of the system when measuring the range of motion (ROM) of the the fingers among healthy people (control group).
  2. To examine the correlation between the ROM measured by the HandTutor and the ROM measured by conventional assessment tools (goniometer).
  3. To examine the ability of the system to distinguish between healthy people and hand injured people.
  4. To examine the correlation between the performance in the HandTutor (in the games part), and the performance in functional activities.
  5. To examine the participants feedback for using the HandTutor (degree of enjoyment).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Naẕerat 'Illit, Israel
        • Clalit Health Service, Southern Clinic, Occupational Therapy Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hand Injuries causing a disfunction of one finger or more of the fingers 2nd-5th.
  • Six weeks at least after the injury/surgery.
  • Allowed to exercise their fingers with no contraindications according to the orthopedic surgeon instructions.
  • With no open wounds.

Exclusion Criteria:

  • Peripheral nerves injuries.
  • Digital nerves injuries.
  • Sensation problems.
  • CRPS-complex regional pain syndrome.
  • Cognitive impairments.
  • Head trauma.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Healthy participants
Healthy participants aged from 18 to 60 with no history of hand injuries recruited by convenience sampling.
Device: HandTutor System
Computerized system designed to evaluate and rehabilitate hand function. It is composed of a glove with special sensors detecting the movements of the wrist and the fingers, with a biofeedback software designed to evaluate and then to exercise the hand movements through supplying a variety of computer graphic patterns.
EXPERIMENTAL: Hand Injured participants
Participants with hand injuries aged from 18 to 60 recruited from the outpatients attending the occupational therapy clinic.
Device: HandTutor System
Computerized system designed to evaluate and rehabilitate hand function. It is composed of a glove with special sensors detecting the movements of the wrist and the fingers, with a biofeedback software designed to evaluate and then to exercise the hand movements through supplying a variety of computer graphic patterns.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
range of movement (ROM)
Time Frame: up to 12 months after the injury
Passive and active ROM measured by goniometer, passive and active ROM measured by HandTutor
up to 12 months after the injury

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
performance in HandTutor
Time Frame: up to 12 months after the injury
The final score the participants get when exercising with the HandTutor.
up to 12 months after the injury
daily life functioning
Time Frame: up to 12 months after the injury
Measured by DASH-Disability of Arm,Shoulder and Hand Questionnaire, and by Jebsen-Taylor Hand Function Test.
up to 12 months after the injury
motor performance skills
Time Frame: up to 12 months after the injury
Measured by Purdue Pegboard Test
up to 12 months after the injury
enjoyment
Time Frame: up to 12 months after the injury
Measured by SFQ-Specific feedback questionnaire.
up to 12 months after the injury
pain
Time Frame: up to 12 months after the injury
Measured by VAS-Visual analogue scale.
up to 12 months after the injury

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Investigators

  • Study Director: Manal A. Najjar, M.Sc. in O.T, Clalit Health Service, Southern Clinic, Occupational Therapy Department, Naẕerat 'Illit, Israel, 04-6557444, manalaz@clalit.org.il

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2010

Primary Completion (ACTUAL)

February 1, 2012

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

August 29, 2010

First Submitted That Met QC Criteria

September 28, 2010

First Posted (ESTIMATE)

September 29, 2010

Study Record Updates

Last Update Posted (ACTUAL)

April 17, 2018

Last Update Submitted That Met QC Criteria

April 12, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMC10k112/2010CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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