Range of MotionKinectROMNCT03731507

KinectROM Application for Assessing Range of Motion in Upper and Lower Extremity: A Development and Validation Study

A study of Range of Motion, run by Saime Nilay Arman at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The aim of the study is to investigate the validity and reliability of KinectROM application for objectively evaluating range of motion (ROM) Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Range of Motion
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 5 Nov 2018to 15 Dec 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

None listed.

Who cannot join

-Have any limited extremity between the ages of 18-40 years.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Istanbul University-Cerrahpasa
Istanbul, 34740

Other trials in Turkey (Türkiye)

About this study

The aim of the study is to investigate the validity and reliability of KinectROM application for objectively evaluating range of motion (ROM)

Read the detailed description

The application KinectROM called has been developed for assessing ROM with Kinect controller by our team. So, shoulder, elbow, knee, hip and ankle ROM measurements will be made with universal goniometer and developed KinectROM application.

Conditions: Range of Motion
Being tested: Assessment of Range of Motion with Kinect Controller
Keywords: range of motion, upper extremity, lower extremity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Assessment of Range of Motion with Kinect ControllerDevice
A ROM measurement method called as KinectROM by us has been developed with Kinect Controller

Study groups in NCT03731507
Study group	Role	What they receive
Range of motion in upper extremity	Experimental	Assessment of shoulder: flexion/extension, abduction/adduction, internal/external rotation, elbow flexion/extension, hip: flexion/extension, abduction/adduction, internal/external rotation, knee: flexion/extension, ankle: dorsal flexion/plantar flexion Receives: Device: Assessment of Range of Motion with Kinect Controller

What is being measured

The primary outcome is the main question the study is designed to answer.

Range of Motion
ROM of shoulder, elbow, knee, hip and ankle will be made with universal goniometer and developed Kinect controller based measurement method.
Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Nov 201815 Dec 2018

First posted6 Nov 2018
Study start5 Nov 2018
Primary completion30 Nov 2018
Study completion15 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Range of MotionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03731507
Sponsor's protocol ID: IstanbulUC
Acronym: KinectROM
Status last verified: Jul 2020
First submitted: 3 Nov 2018
Last updated: 29 Jul 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Range of Motion trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: KinectROM Application for Assessing Range of Motion in Upper and Lower Extremity: A Development and Validation Study
ClinicalTrials.gov ID: NCT03731507
Acronym / sponsor ID: KinectROM / IstanbulUC
Conditions: Range of Motion
Keywords: range of motion, upper extremity, lower extremity
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: Saime Nilay ArmanUniversity, hospital or other
Study start: 5 Nov 2018 (actual)
Primary completion: 30 Nov 2018 (actual)
Study completion: 15 Dec 2018 (actual)
First posted: 6 Nov 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The aim of the study is to investigate the validity and reliability of KinectROM application for objectively evaluating range of motion (ROM)

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Range of motion in upper extremity	Experimental	Device: Assessment of Range of Motion with Kinect ControllerAssessment of shoulder: flexion/extension, abduction/adduction, internal/external rotation, elbow flexion/extension, hip: flexion/extension, abduction/adduction, internal/external rotation, knee: flexion/extension, ankle: dorsal flexion/plantar flexion

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (0 listed)

Key exclusion criteria (1 listed)

-Have any limited extremity between the ages of 18-40 years.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Assessment of Range of Motion with Kinect ControllerA ROM measurement method called as KinectROM by us has been developed with Kinect Controller	Device	Range of motion in upper extremity

Primary outcome

Range of Motion
Time frame: baseline
ROM of shoulder, elbow, knee, hip and ankle will be made with universal goniometer and developed Kinect controller based measurement method.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.

Related trials for Range of Motion

Active, not recruiting
PICU Up!: A Pilot Stepped-wedge Trial of a Multicomponent Early Mobility Intervention for Critically Ill Children
Critical Illness
Not yet recruiting
Effects of Mobilization With and Without Suboccipital Muscle Release on Pain, Range of Motion, and Disability in Mechanical Neck Pain
Mechanical Neck Pain
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy
Not yet recruiting
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Chronic Subacromial Impingement Syndrome
Not yet recruitingObservational study
Results of Medical and Nursing Record,Physical Examination, Blood Test and Radiological Examination of Multiple Trauma to Find the Correlation With Patient's Morality and Mobility
Trauma Centers/Statistics & Numerical Data, Trauma Blunt

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study of Range of Motion, run by Saime Nilay Arman at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Range of Motion (time frame: baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03731507.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.