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Using HandTutor With Traumatic Hand Injuries: Characterizing the System

This study is currently recruiting participants.
Verified March 2012 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01210833
First received: August 29, 2010
Last updated: March 16, 2012
Last verified: March 2012
History of Changes
  Purpose

HandTutor is a 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.

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

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

  1. To examine the test-retest reliability when measuring the range of movement(ROM) of the wrist and the fingers with the system.
  2. To examine the correlation between the ROM when measured by the HandTutor, and the ROM when measured by a conventional tools (goniometer).
  3. To examine the correlation between the performance in the HandTutor (in the games part), and the performance in functional activities.
  4. To examine the difference between healthy people and hand injured people when using the HandTutor.
  5. To examine the participants feedback for using the HandTutor (Level of enjoyment,etc).
  6. To examine the level of pain that participants with hand injury experience when using the HandTutor.

Condition Intervention
Hand Injuries.
 Device: HandTutor System

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Using HandTutor With Traumatic Hand Injuries: Characterizing the System

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • range of movement (ROM) [ Time Frame: up to 12 months after the injury ] [ Designated as safety issue: No ]
    Passive and active ROM measured by goniometer, passive and active ROM measured by HandTutor


Secondary Outcome Measures:
  • performance in HandTutor [ Time Frame: up to 12 months after the injury ] [ Designated as safety issue: No ]
    The final score the participants get when exercising with the HandTutor.

  • daily life functioning [ Time Frame: up to 12 months after the injury ] [ Designated as safety issue: No ]
    Measured by DASH-Disability of Arm,Shoulder and Hand Questionnaire, and by Jebsen-Taylor Hand Function Test.

  • motor performance skills [ Time Frame: up to 12 months after the injury ] [ Designated as safety issue: No ]
    Measured by Purdue Pegboard Test

  • enjoyment [ Time Frame: up to 12 months after the injury ] [ Designated as safety issue: No ]
    Measured by SFQ-Specific feedback questionnaire.

  • pain [ Time Frame: up to 12 months after the injury ] [ Designated as safety issue: No ]
    Measured by VAS-Visual analogue scale.


Estimated Enrollment: 40
Study Start Date: October 2010
Estimated Study Completion Date: December 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Healthy People 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 Injuries 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01210833

Locations
Israel
Clalit Health Service, Southern Clinic, Occupational Therapy Department Recruiting
Nazareth Illit, Israel
Contact: Manal Najjar, O.T     04-6557444     manalaz@clalit.org.il    
Sub-Investigator: Manal Najjar, Occupational Therapist            
Sponsors and Collaborators
Meir Medical Center
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01210833     History of Changes
Other Study ID Numbers: MMC10k112/2010CTIL
Study First Received: August 29, 2010
Last Updated: March 16, 2012
Health Authority: Israel: Clalit Health Services

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

Additional relevant MeSH terms:
Hand Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013