NCT03622645

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

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

Study Start

First participant enrolled

January 13, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2018

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

November 6, 2018

Status Verified

November 1, 2018

Enrollment Period

1.6 years

First QC Date

July 24, 2018

Last Update Submit

November 3, 2018

Conditions

Range of Motion

Keywords

Range of motionWristHandFingerMeasurement

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Range of motion in hand

EXPERIMENTAL

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

Interventions

Assessment of Range of Motion with Leap Motion sensorDEVICE

An ROM measurement method called as HandROM by us will be developed with leap motion sensor

Range of motion in hand

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy individuals

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Arman N, Oktay AB, Tarakci D, Tarakci E, Akgul YS. The validity of an objective measurement method using the Leap Motion Controller for fingers wrist, and forearm ranges of motion. Hand Surg Rehabil. 2021 Sep;40(4):394-399. doi: 10.1016/j.hansur.2021.03.007. Epub 2021 Mar 26.

    PMID: 33781957DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 24, 2018

First Posted

August 9, 2018

Study Start

January 13, 2017

Primary Completion

August 29, 2018

Study Completion

September 1, 2018

Last Updated

November 6, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share