NCT01210833

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:

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 29, 2010

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

1.3 years

First QC Date

August 29, 2010

Last Update Submit

April 12, 2018

Conditions

Hand Injuries

Keywords

Finger FracturesTendon InjuriesSoft Tissue Injuries

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • performance in HandTutor

    up to 12 months after the injury

  • daily life functioning

    up to 12 months after the injury

  • motor performance skills

    up to 12 months after the injury

  • enjoyment

    up to 12 months after the injury

  • pain

    up to 12 months after the injury

Study Arms (2)

Healthy participants

ACTIVE COMPARATOR

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

Device: HandTutor System

Hand Injured participants

EXPERIMENTAL

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

Device: HandTutor System

Interventions

HandTutor SystemDEVICE

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.

Hand Injured participantsHealthy participants

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Peripheral nerves injuries.
  • Digital nerves injuries.
  • Sensation problems.
  • CRPS-complex regional pain syndrome.
  • Cognitive impairments.
  • Head trauma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clalit Health Service, Southern Clinic, Occupational Therapy Department

Naẕerat ‘Illit, Israel

Location

MeSH Terms

Conditions

Hand InjuriesTendon InjuriesSoft Tissue Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Manal A. Najjar, M.Sc. in O.T

    Clalit Health Service, Southern Clinic, Occupational Therapy Department, Naẕerat 'Illit, Israel, 04-6557444, manalaz@clalit.org.il

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2010

First Posted

September 29, 2010

Study Start

October 1, 2010

Primary Completion

February 1, 2012

Study Completion

December 1, 2014

Last Updated

April 17, 2018

Record last verified: 2018-04

Locations

IL(1)