Spatial OrientationNCT03056430
Neuroanatomical and Functional Changes in Response to an Intensive Balance Training
A study testing Training in people with Spatial Orientation and Balance, run by German Center for Neurodegenerative Diseases (DZNE) at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether intensive slackline training improves spatial orientation abilities, balancing skills and causes neuroplasticity in related brain cortical regions. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Spatial Orientation, Balance
- What is being tested?
- Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2016to 31 Dec 2019
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- No previous slacklining or related experience, 18-30 years of age, good or corrected to good vision
Who cannot join
- Musculoskeletal and nervous system injuries/diseases that significantly reduce one's ability to perform slacklining training, systemic diseases (cardiovascular, gastrointestinal, metabolic...)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether intensive slackline training improves spatial orientation abilities, balancing skills and causes neuroplasticity in related brain cortical regions.
- Conditions
- Spatial Orientation, Balance
- Being tested
- Training
- Keywords
- MRI, Neuroplasticity, Balance, Spatial orientation, Hippocampus, Slacklining
- Medical subject headings
- Orientation, Spatial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Training Group 1 | Experimental | Slackline training Receives: Behavioral: Training |
| Training Group 2 | Experimental | Slackline training Receives: Behavioral: Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline at 1 and 3 months in Balance Tests score
Measured: Baseline, 1 month post-test, 3 months post-test
Change from Baseline at 1 and 3 months in Spatial Orientation Tests score
Measured: Baseline, 1 month post-test, 3 months post-test
Change from Baseline at 1 and 3 months in voxel-wise morphometric brain analysis
Measured: Baseline, 1 month post-test, 3 months post-test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2017
- Study start1 Jan 2016
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spatial OrientationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Repeated-measures, 2 groups \* 2 timepoints
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- German Center for Neurodegenerative Diseases (DZNE)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Notger Müller, Prof. Dr., Principal investigator, German Center for Neurodegenerative Diseases (DZNE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03056430
- Sponsor's protocol ID
- MD038
- Status last verified
- Mar 2018
- First submitted
- 27 Dec 2016
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroanatomical and Functional Changes in Response to an Intensive Balance Training
- ClinicalTrials.gov ID
- NCT03056430
- Acronym / sponsor ID
- MD038
- Conditions
- Spatial Orientation, Balance
- Keywords
- MRI, Neuroplasticity, Balance, Spatial orientation, Hippocampus, Slacklining
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- German Center for Neurodegenerative Diseases (DZNE)University, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 17 Feb 2017 (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 purpose of this study is to determine whether intensive slackline training improves spatial orientation abilities, balancing skills and causes neuroplasticity in related brain cortical regions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Repeated-measures, 2 groups * 2 timepoints
| Arm | Type | Receives |
|---|---|---|
| Training Group 1 | Experimental | Behavioral: TrainingSlackline training |
| Training Group 2 | Experimental | Behavioral: TrainingSlackline training |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- No previous slacklining or related experience, 18-30 years of age, good or corrected to good vision
Key exclusion criteria (1 listed)
- Musculoskeletal and nervous system injuries/diseases that significantly reduce one's ability to perform slacklining training, systemic diseases (cardiovascular, gastrointestinal, metabolic...)
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 |
|---|---|---|
| Training | Behavioural | Training Group 1, Training Group 2 |
Primary outcome
Change from Baseline at 1 and 3 months in Balance Tests score
Time frame: Baseline, 1 month post-test, 3 months post-test
Change from Baseline at 1 and 3 months in Spatial Orientation Tests score
Time frame: Baseline, 1 month post-test, 3 months post-test
Change from Baseline at 1 and 3 months in voxel-wise morphometric brain analysis
Time frame: Baseline, 1 month post-test, 3 months post-test
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 23 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Notger Müller, Prof. Dr. principal investigator
German Center for Neurodegenerative Diseases (DZNE)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in people with Spatial Orientation and Balance, run by German Center for Neurodegenerative Diseases (DZNE) at 1 site in Germany.
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 23 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 Germany. 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?
Change from Baseline at 1 and 3 months in Balance Tests score (time frame: Baseline, 1 month post-test, 3 months post-test). The study lists 3 primary outcomes in all. 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 23 Jul 2020.