- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03056430
Neuroanatomical and Functional Changes in Response to an Intensive Balance Training
July 21, 2020 updated by: German Center for Neurodegenerative Diseases (DZNE)
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sachsen-Anhalt
-
Magdeburg, Sachsen-Anhalt, Germany, 39120
- DZNE
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- No previous slacklining or related experience, 18-30 years of age, good or corrected to good vision
Exclusion Criteria:
- Musculoskeletal and nervous system injuries/diseases that significantly reduce one's ability to perform slacklining training, systemic diseases (cardiovascular, gastrointestinal, metabolic...)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Training Group 1
Slackline training
|
|
|
Experimental: Training Group 2
Slackline training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change from Baseline at 1 and 3 months in Balance Tests score
Time Frame: Baseline, 1 month post-test, 3 months post-test
|
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
|
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
|
Baseline, 1 month post-test, 3 months post-test
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Actual)
December 31, 2019
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
December 27, 2016
First Submitted That Met QC Criteria
February 14, 2017
First Posted (Actual)
February 17, 2017
Study Record Updates
Last Update Posted (Actual)
July 23, 2020
Last Update Submitted That Met QC Criteria
July 21, 2020
Last Verified
March 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- MD038
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.