Neuroanatomical and Functional Changes in Response to an Intensive Balance Training

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

Tracking Information

• First Submitted Date: December 27, 2016
• First Posted Date: February 17, 2017
• Last Update Posted Date: July 23, 2020
• Actual Study Start Date: January 1, 2016
• Actual Primary Completion Date: December 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Neuroanatomical and Functional Changes in Response to an Intensive Balance Training
• Official Title: 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: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:

Repeated-measures, 2 groups * 2 timepoints

Masking: None (Open Label)
Primary Purpose: Prevention

Condition

• Spatial Orientation
• Balance

• Intervention: Behavioral: Training

Study Arms

• Experimental: Training Group 1
  Slackline training
  Intervention: Behavioral: Training
• Experimental: Training Group 2
  Slackline training
  Intervention: Behavioral: Training

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: February 14, 2017): 60
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 31, 2019
• Actual Primary Completion Date: December 31, 2019 (Final data collection date for primary outcome measure)

Eligibility 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...)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 35 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT03056430
• Other Study ID Numbers: MD038
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: German Center for Neurodegenerative Diseases (DZNE)
• Study Sponsor: German Center for Neurodegenerative Diseases (DZNE)
• Collaborators: Not Provided

Investigators

• Principal Investigator: Notger Müller, Prof. Dr.; German Center for Neurodegenerative Diseases (DZNE)

• PRS Account: German Center for Neurodegenerative Diseases (DZNE)
• Verification Date: March 2018