Using HandTutor With Traumatic Hand Injuries: Characterizing the System

Hand Injuries Clinical Trial

Official title:

Using HandTutor With Traumatic Hand Injuries: Characterizing the System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01210833
• Other study ID #: MMC10k112/2010CTIL
• Status: Completed
• Phase: N/A
• First received: August 29, 2010
• Last updated: April 12, 2018
• Start date: October 2010
• Est. completion date: December 2014

Study information

• Verified date: April 2018
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2014
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hand Injuries
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Israel	Clalit Health Service, Southern Clinic, Occupational Therapy Department	Na?erat 'Illit

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	range of movement (ROM)	Passive and active ROM measured by goniometer, passive and active ROM measured by HandTutor	up to 12 months after the injury
Secondary	performance in HandTutor	The final score the participants get when exercising with the HandTutor.	up to 12 months after the injury
Secondary	daily life functioning	Measured by DASH-Disability of Arm,Shoulder and Hand Questionnaire, and by Jebsen-Taylor Hand Function Test.	up to 12 months after the injury
Secondary	motor performance skills	Measured by Purdue Pegboard Test	up to 12 months after the injury
Secondary	enjoyment	Measured by SFQ-Specific feedback questionnaire.	up to 12 months after the injury
Secondary	pain	Measured by VAS-Visual analogue scale.	up to 12 months after the injury