Using HandTutor With Traumatic Hand Injuries: Characterizing the System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01210833
First received: August 29, 2010
Last updated: June 3, 2015
Last verified: May 2015
  Purpose

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 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:


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.


Enrollment: 30
Study Start Date: October 2010
Study Completion Date: December 2014
Primary Completion Date: February 2012 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01210833

Locations
Israel
Clalit Health Service, Southern Clinic, Occupational Therapy Department
Nazareth Illit, Israel
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: June 3, 2015
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 July 26, 2015