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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01210833
Other study ID # MMC10k112/2010CTIL
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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