Changes in Blood Flow to the BrainNCT01254968
Influence of Direction of Movement While Walking
An observational study of Changes in Blood Flow to the Brain and Changes Depending on the Form of Walking, run by Medical University of Silesia at 1 site in Poland.
Trial summary
The aim of the study is evaluation of cerebral blood flow (based on testing the rate of flow in middle cerebral arteries by transcranial Doppler ultrasound) during different forms of walking training - walk forwards and backwards, with closed and open eyes. Read more about this study
- Who is it for?
- Ages 20 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Changes in Blood Flow to the Brain, Changes Depending on the Form of Walking
- How many people
- 1 participants
- Where
- 1 sitePoland
- Study dates
- Dec 2008to Apr 2009
- 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 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 20 healthy subjects (11 men, 9 women, average age 23.94) participated in a study measuring the speed of blood flow in middle cerebral arteries using transcranial Doppler (transcranial Doppler Sonography) while walking on a treadmill.
Who may be able to join
- healthy subjects without brain disease
Who cannot join
- brain disease and walking disfunctions
Trial locations and contacts
1 site in 1 country.
Poland1 site
Medical University of Silesia
Katowice, Silesian Voivodeship, 40-055
About this study
Official title: Influence of Direction of Movement While Walking Upon the Blood Flow Rate Through Brain, Examined by Transcranial Doppler Sonography in Young Healthy Subjects.
The aim of the study is evaluation of cerebral blood flow (based on testing the rate of flow in middle cerebral arteries by transcranial Doppler ultrasound) during different forms of walking training - walk forwards and backwards, with closed and open eyes.
Read the detailed description
In the third minute of training walking a significant increase in blood flow velocity was recorded, both in right and left middle cerebral arteries. It was observed in the left artery during all forms of training. In the right artery it occurred only during three forms of difficult training, and was preceded by significant decrease in blood flow in the first minute of the gait with eyes closed. The output values of the rate of blood flow in both right and left middle cerebral arteries became progressively reduced in the successive stages of gait. Pressure and pulse rates did not correlate with the variables of blood flow velocity in middle cerebral arteries.
- Keywords
- blood flow in the middle cerebral artery of brain
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 |
|---|---|---|
| examining group | 20 healthy subjects (11 men, 9 women, average age 23.94) | |
| control group | 6 healthy subjects (3 men, 3 women, average age 23.6) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcranial Doppler sonography in young healthy subjects.
Significant changes in blood flow to the brain depending on the form of walking and its conditions were observed. Changes in the right middle cerebral artery were more diverse than in the left artery. Difficulty in walking training forms gave long-term vasodilation.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2010 (estimated)
- Study startDec 2008
- Primary completionJan 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Changes in Blood Flow to the BrainStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01254968
- Sponsor's protocol ID
- BW-07-AM
- Status last verified
- Nov 2010
- First submitted
- 29 Nov 2010
- Last updated
- 7 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Direction of Movement While Walking Upon the Blood Flow Rate Through Brain, Examined by Transcranial Doppler Sonography in Young Healthy Subjects.
- ClinicalTrials.gov ID
- NCT01254968
- Acronym / sponsor ID
- BW-07-AM
- Keywords
- blood flow in the middle cerebral artery of brain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 7 Dec 2010 (estimated)
- 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 evaluation of cerebral blood flow (based on testing the rate of flow in middle cerebral arteries by transcranial Doppler ultrasound) during different forms of walking training - walk forwards and backwards, with closed and open eyes.
Detailed description
In the third minute of training walking a significant increase in blood flow velocity was recorded, both in right and left middle cerebral arteries. It was observed in the left artery during all forms of training. In the right artery it occurred only during three forms of difficult training, and was preceded by significant decrease in blood flow in the first minute of the gait with eyes closed. The output values of the rate of blood flow in both right and left middle cerebral arteries became progressively reduced in the successive stages of gait. Pressure and pulse rates did not correlate with the variables of blood flow velocity in middle cerebral arteries.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| examining group | – | –20 healthy subjects (11 men, 9 women, average age 23.94) |
| control group | – | –6 healthy subjects (3 men, 3 women, average age 23.6) |
Who may qualify
- Ages
- 20 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 20 healthy subjects (11 men, 9 women, average age 23.94) participated in a study measuring the speed of blood flow in middle cerebral arteries using transcranial Doppler (transcranial Doppler Sonography) while walking on a treadmill.
Key inclusion criteria (1 listed)
- healthy subjects without brain disease
Key exclusion criteria (1 listed)
- brain disease and walking disfunctions
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
Transcranial Doppler sonography in young healthy subjects.
Time frame: 5 months
Significant changes in blood flow to the brain depending on the form of walking and its conditions were observed. Changes in the right middle cerebral artery were more diverse than in the left artery. Difficulty in walking training forms gave long-term vasodilation.
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 7 Dec 2010.
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?
An observational study of Changes in Blood Flow to the Brain and Changes Depending on the Form of Walking, run by Medical University of Silesia at 1 site in Poland.
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 1 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 7 Dec 2010. 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 Poland. 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?
Transcranial Doppler sonography in young healthy subjects. (time frame: 5 months). 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 7 Dec 2010.