HealthyNCT04296084
Upper Extremity Kinematics During Walking
An observational study of Healthy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Our aim is to investigate the upper extremity kinematics during walking in healthy individuals. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Healthy
- How many people
- 47 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Mar 2020to 12 May 2020
- Phase
- Observational
- 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 20 to 40 years
- All sexes
- Adult
Study population: Healthy individuals in the age of 20-40 years
Who may be able to join
- Between the ages of 20 and 40 years individuals
- Without any medical condition that would affect gait or arm swing
Who cannot join
- People with upper or lower limb asymmetry
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Physical Therapy and Rehabilitation
Ankara, Altındağ, 06100
About this study
Official title: Determination of Upper Extremity Kinematics During Walking in Healthy Individuals
Our aim is to investigate the upper extremity kinematics during walking in healthy individuals.
Read the detailed description
Determination of Upper Extremity Kinematics During Walking
- Conditions
- Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| healthy individuals | Volunteer healthy individuals who are between the ages of 20-40 and who do not have any medical condition to affect gait or arm swing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinematic analysis
For kinematic analysis, MVN BIOMECH Awinda MTW2-3A7G6 sensors (Xsens Technologies B.V. Enschede, The Netherlands) were used. A Kalman filter (Xsens Kalman Filter, XKF) was used for 3D reconstruction of body segment position and orientation. IMU sensors were placed in accordance with the anatomical regions found in the directive issued by the International Biomechanics Association. Joint kinematic data of bilateral upper limb, lower limb and trunk were recorded with IMU sensors and wireless station. Xsens MVN Studio 4.6 was used to track IMU orientations according to the world-based coordinate framework. To make an effective analysis, gloves, vests and velcro were used to attach sensors to the extremities and body.
Measured: up to 20 weeks
Secondary outcomes (1)
Time-Distance Characteristics of the Gait
GAITRite (CIR System INC. Clifton, NJ 07012) walkway system will be used. GAITRite; It is an electronic walkway which consists of portable carpet and sensors embedded on the carpet and transfers every foot contact to the computer when individuals walk on the carpet. With GAITRite, base of support (cm), velocity (cm / s) and cadence (steps / min) parameters will be evaluated.
Measured: up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start9 Mar 2020
- Primary completion10 May 2020
- Study completion12 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Güngör Beyza ÖZVAR, Hacettepe University
- Investigators
- Ali İ Yalçın, MSc, Principal investigator, Hacettepe UniversityBurcu Şahin, MSc, Principal investigator, Hacettepe UniversityDilara Onan, MSc, Principal investigator, Hacettepe UniversityMert Doğan, MSc, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04296084
- Sponsor's protocol ID
- Kinematic analysis in walking
- Status last verified
- May 2020
- First submitted
- 27 Feb 2020
- Last updated
- 29 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Upper Extremity Kinematics During Walking in Healthy Individuals
- ClinicalTrials.gov ID
- NCT04296084
- Acronym / sponsor ID
- Kinematic analysis in walking
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 10 May 2020 (actual)
- Study completion
- 12 May 2020 (actual)
- First posted
- 5 Mar 2020 (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.
Our aim is to investigate the upper extremity kinematics during walking in healthy individuals.
Detailed description
Determination of Upper Extremity Kinematics During Walking
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy individuals | – | –Volunteer healthy individuals who are between the ages of 20-40 and who do not have any medical condition to affect gait or arm swing. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Age groups
- Adult
- Study population
- Healthy individuals in the age of 20-40 years
Key inclusion criteria (2 listed)
- Between the ages of 20 and 40 years individuals
- Without any medical condition that would affect gait or arm swing
Key exclusion criteria (1 listed)
- People with upper or lower limb asymmetry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Kinematic analysis
Time frame: up to 20 weeks
For kinematic analysis, MVN BIOMECH Awinda MTW2-3A7G6 sensors (Xsens Technologies B.V. Enschede, The Netherlands) were used. A Kalman filter (Xsens Kalman Filter, XKF) was used for 3D reconstruction of body segment position and orientation. IMU sensors were placed in accordance with the anatomical regions found in the directive issued by the International Biomechanics Association. Joint kinematic data of bilateral upper limb, lower limb and trunk were recorded with IMU sensors and wireless station. Xsens MVN Studio 4.6 was used to track IMU orientations according to the world-based coordinate framework. To make an effective analysis, gloves, vests and velcro were used to attach sensors to the extremities and body.
1 secondary outcome
Time-Distance Characteristics of the Gait
Time frame: up to 20 weeks
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 Dec 2020.
Related trials for Healthy
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Recruiting
Metabolic Impact of VLCPUFA-Rich Fish Oil: A Clinical Study on Omega-3 Index Enhancement in Healthy Individuals
Fatty Acids, Omega-3, Fish Oils
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.
Ali İ Yalçın, MSc principal investigator
Hacettepe University
Burcu Şahin, MSc principal investigator
Hacettepe University
Dilara Onan, MSc principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Hacettepe University 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 2 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 Dec 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?
Kinematic analysis (time frame: up to 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2020.