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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03622645
Other study ID # 10840098-604
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 13, 2017
Est. completion date September 1, 2018

Study information

Verified date November 2018
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date September 1, 2018
Est. primary completion date August 29, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- Healthy individuals

Exclusion Criteria:

- Have any hand/wrist problems between the ages of 18-40 years.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University

Outcome

Type Measure Description Time frame Safety issue
Primary Range of Motion 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. Baseline
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