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Using HandTutor With Traumatic Hand Injuries: Characterizing the System

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ClinicalTrials.gov Identifier: NCT01210833
Recruitment Status : Completed
First Posted : September 29, 2010
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

Brief Summary:

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).

Condition or disease Intervention/treatment Phase
Hand Injuries Device: HandTutor System Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Using HandTutor With Traumatic Hand Injuries: Characterizing the System
Actual Study Start Date : October 2010
Actual Primary Completion Date : February 2012
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. performance in HandTutor [ Time Frame: up to 12 months after the injury ]
    The final score the participants get when exercising with the HandTutor.

  2. 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.

  3. motor performance skills [ Time Frame: up to 12 months after the injury ]
    Measured by Purdue Pegboard Test

  4. enjoyment [ Time Frame: up to 12 months after the injury ]
    Measured by SFQ-Specific feedback questionnaire.

  5. pain [ Time Frame: up to 12 months after the injury ]
    Measured by VAS-Visual analogue scale.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01210833


Locations
Israel
Clalit Health Service, Southern Clinic, Occupational Therapy Department
Naẕerat 'Illit, Israel
Sponsors and Collaborators
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

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01210833     History of Changes
Other Study ID Numbers: MMC10k112/2010CTIL
First Posted: September 29, 2010    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018

Keywords provided by Meir Medical Center:
Finger Fractures
Tendon Injuries
Soft Tissue Injuries

Additional relevant MeSH terms:
Wounds and Injuries
Hand Injuries