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Neuroanatomical and Functional Changes in Response to an Intensive Balance Training

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ClinicalTrials.gov Identifier: NCT03056430
Recruitment Status : Completed
First Posted : February 17, 2017
Last Update Posted : July 23, 2020
Sponsor:
Information provided by (Responsible Party):
German Center for Neurodegenerative Diseases (DZNE)

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Spatial Orientation Balance Behavioral: Training Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Repeated-measures, 2 groups * 2 timepoints
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Neuroanatomical and Functional Changes in Response to an Intensive Balance Training
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Training Group 1
Slackline training
 Behavioral: Training
Experimental: Training Group 2
Slackline training
 Behavioral: Training


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline at 1 and 3 months in Balance Tests score [ Time Frame: Baseline, 1 month post-test, 3 months post-test ]
  2. Change from Baseline at 1 and 3 months in Spatial Orientation Tests score [ Time Frame: Baseline, 1 month post-test, 3 months post-test ]
  3. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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...)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056430


Locations
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Germany
DZNE
Magdeburg, Sachsen-Anhalt, Germany, 39120
Sponsors and Collaborators
German Center for Neurodegenerative Diseases (DZNE)
Investigators
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Principal Investigator: Notger Müller, Prof. Dr. German Center for Neurodegenerative Diseases (DZNE)
More Information
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Responsible Party: German Center for Neurodegenerative Diseases (DZNE)
ClinicalTrials.gov Identifier: NCT03056430    
Other Study ID Numbers: MD038
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by German Center for Neurodegenerative Diseases (DZNE):
MRI, Neuroplasticity, Balance, Spatial orientation, Hippocampus, Slacklining