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An Objective Measurement Method With The Leap Motion Sensor For Hand And Wrist's Range Of Motion

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ClinicalTrials.gov Identifier: NCT03622645
Recruitment Status : Completed
First Posted : August 9, 2018
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Saime Nilay Arman, Istanbul University

Study Description
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Brief Summary:
The aim of the study was to develop a low cost, clinically easy to use measurement method with the Leap motion sensor for objectively evaluating range of motion (ROM), and to investigate the validity and reliability of this application.

Condition or disease Intervention/treatment Phase
Range of Motion Device: Assessment of Range of Motion with Leap Motion sensor Not Applicable

Detailed Description:

. Wrist flexion / extension, radial / ulnar deviation, supination / pronation, 1.-5. of the fingers DIP, PIP and MCP flexion / extension ROM measurements will be made with universal goniometer and developed Leap motion sensor (LMC) based measurement method.

The study consists of two basic steps:

  1. Development of measurement method with LMC Identification of normROM measurement procedure Identification of ROM measurement reporting Establishing the precursor version of the software of the measurement method Checking ROM measurement performance criteria and providing feedback Measuring the movement defined on 5 persons and providing feedback Creation of the last available version of the measurement method
  2. Validity and reliability study Measurements of hand and wrist ROM with developed measurement method with LMC and universal goniometer for three times and calculation mean of three measurement for two methods
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Developing An Objective Measurement Method With The Leap Motion Sensor For Hand And Wrist's Range Of Motion: Validity And Reliability Study
Actual Study Start Date : January 13, 2017
Actual Primary Completion Date : August 29, 2018
Actual Study Completion Date : September 1, 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: Range of motion in hand
Assessment of Wrist flexion/extension, radial/ulnar deviation, supination/pronation, 1.-5. DIP, PIP and MCP flexion/extension ROM measurements of the fingers with universal goniometer and Leap motion sensor
 Device: Assessment of Range of Motion with Leap Motion sensor
An ROM measurement method called as HandROM by us will be developed with leap motion sensor


Outcome Measures
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Primary Outcome Measures :
  1. Range of Motion [ Time Frame: Baseline ]
    Wrist flexion / extension, radial / ulnar deviation, supination / pronation, 1. -5. DIP, PIP and MCP flexion / extension EHA measurements of the fingers will be made with universal goniometer and developed Leap motion sensor based measurement method.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy individuals

Exclusion Criteria:

  • Have any hand/wrist problems between the ages of 18-40 years.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Saime Nilay Arman, Principal Investigator, Istanbul University
ClinicalTrials.gov Identifier: NCT03622645    
Other Study ID Numbers: 10840098-604
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Saime Nilay Arman, Istanbul University:
Range of motion
Wrist
Hand
Finger
Measurement