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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)

Tracking Information
First Submitted Date  ICMJE December 27, 2016
First Posted Date  ICMJE February 17, 2017
Last Update Posted Date July 23, 2020
Actual Study Start Date  ICMJE January 1, 2016
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2017)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neuroanatomical and Functional Changes in Response to an Intensive Balance Training
Official Title  ICMJE Neuroanatomical and Functional Changes in Response to an Intensive Balance Training
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:
Repeated-measures, 2 groups * 2 timepoints
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Spatial Orientation
  • Balance
Intervention  ICMJE Behavioral: Training
Study Arms  ICMJE
  • Experimental: Training Group 1
    Slackline training
    Intervention: Behavioral: Training
  • Experimental: Training Group 2
    Slackline training
    Intervention: Behavioral: Training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: February 14, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2019
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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...)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03056430
Other Study ID Numbers  ICMJE MD038
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party German Center for Neurodegenerative Diseases (DZNE)
Study Sponsor  ICMJE German Center for Neurodegenerative Diseases (DZNE)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Notger Müller, Prof. Dr. German Center for Neurodegenerative Diseases (DZNE)
PRS Account German Center for Neurodegenerative Diseases (DZNE)
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP