- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03622645
An Objective Measurement Method With The Leap Motion Sensor For Hand And Wrist's Range Of Motion
November 3, 2018 updated by: Saime Nilay Arman, Istanbul University
Developing An Objective Measurement Method With The Leap Motion Sensor For Hand And Wrist's Range Of Motion: Validity And Reliability Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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:
- 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
- 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 Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy individuals
Exclusion Criteria:
- Have any hand/wrist problems between the ages of 18-40 years.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / 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
|
An ROM measurement method called as HandROM by us will be developed with leap motion sensor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 13, 2017
Primary Completion (ACTUAL)
August 29, 2018
Study Completion (ACTUAL)
September 1, 2018
Study Registration Dates
First Submitted
July 24, 2018
First Submitted That Met QC Criteria
August 7, 2018
First Posted (ACTUAL)
August 9, 2018
Study Record Updates
Last Update Posted (ACTUAL)
November 6, 2018
Last Update Submitted That Met QC Criteria
November 3, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 10840098-604
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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