search
Back to results

Using HandTutor With Traumatic Hand Injuries: Characterizing the System

Primary Purpose

Hand Injuries

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
HandTutor System
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hand Injuries focused on measuring Finger Fractures, Tendon Injuries, Soft Tissue Injuries

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Clalit Health Service, Southern Clinic, Occupational Therapy Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Healthy participants

Hand Injured participants

Arm Description

Healthy participants aged from 18 to 60 with no history of hand injuries recruited by convenience sampling.

Participants with hand injuries aged from 18 to 60 recruited from the outpatients attending the occupational therapy clinic.

Outcomes

Primary Outcome Measures

range of movement (ROM)
Passive and active ROM measured by goniometer, passive and active ROM measured by HandTutor

Secondary Outcome Measures

performance in HandTutor
The final score the participants get when exercising with the HandTutor.
daily life functioning
Measured by DASH-Disability of Arm,Shoulder and Hand Questionnaire, and by Jebsen-Taylor Hand Function Test.
motor performance skills
Measured by Purdue Pegboard Test
enjoyment
Measured by SFQ-Specific feedback questionnaire.
pain
Measured by VAS-Visual analogue scale.

Full Information

First Posted
August 29, 2010
Last Updated
April 12, 2018
Sponsor
Meir Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01210833
Brief Title
Using HandTutor With Traumatic Hand Injuries: Characterizing the System
Official Title
Using HandTutor With Traumatic Hand Injuries: Characterizing the System
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
October 2010 (Actual)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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). To examine the correlation between the ROM measured by the HandTutor and the ROM measured by conventional assessment tools (goniometer). To examine the ability of the system to distinguish between healthy people and hand injured people. To examine the correlation between the performance in the HandTutor (in the games part), and the performance in functional activities. To examine the participants feedback for using the HandTutor (degree of enjoyment).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Injuries
Keywords
Finger Fractures, Tendon Injuries, Soft Tissue Injuries

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy participants
Arm Type
Active Comparator
Arm Description
Healthy participants aged from 18 to 60 with no history of hand injuries recruited by convenience sampling.
Arm Title
Hand Injured participants
Arm Type
Experimental
Arm Description
Participants with hand injuries aged from 18 to 60 recruited from the outpatients attending the occupational therapy clinic.
Intervention Type
Device
Intervention Name(s)
HandTutor System
Intervention Description
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 Measure Information:
Title
range of movement (ROM)
Description
Passive and active ROM measured by goniometer, passive and active ROM measured by HandTutor
Time Frame
up to 12 months after the injury
Secondary Outcome Measure Information:
Title
performance in HandTutor
Description
The final score the participants get when exercising with the HandTutor.
Time Frame
up to 12 months after the injury
Title
daily life functioning
Description
Measured by DASH-Disability of Arm,Shoulder and Hand Questionnaire, and by Jebsen-Taylor Hand Function Test.
Time Frame
up to 12 months after the injury
Title
motor performance skills
Description
Measured by Purdue Pegboard Test
Time Frame
up to 12 months after the injury
Title
enjoyment
Description
Measured by SFQ-Specific feedback questionnaire.
Time Frame
up to 12 months after the injury
Title
pain
Description
Measured by VAS-Visual analogue scale.
Time Frame
up to 12 months after the injury

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manal A. Najjar, M.Sc. in O.T
Organizational Affiliation
Clalit Health Service, Southern Clinic, Occupational Therapy Department, Naẕerat 'Illit, Israel, 04-6557444, manalaz@clalit.org.il
Official's Role
Study Director
Facility Information:
Facility Name
Clalit Health Service, Southern Clinic, Occupational Therapy Department
City
Naẕerat 'Illit
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

Using HandTutor With Traumatic Hand Injuries: Characterizing the System

We'll reach out to this number within 24 hrs