Neuroanatomical and Functional Changes in Response to an... | NCT03056430

Studies
Neuroanatomical and Functional Changes in Response to an Intensive Balance Training

NCT03056430

Sponsor

German Center for Neurodegenerative Diseases (DZNE)

Status

Completed

Last Update Posted

Jul 23, 2020Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Spatial Orientation
Balance

Interventions

Training

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2016Actual

Primary Completion Date

Dec 31, 2019Actual

Completion Date

Dec 31, 2019Actual

First Submitted Date

Dec 27, 2016

First Submission Date that Met QC Criteria

Feb 14, 2017

First Posted Date

Feb 17, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 21, 2020

Last Update Posted Date

Jul 23, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Training Group 1	Experimental	Slackline training	Behavioral: Training
Training Group 2	Experimental	Slackline training	Behavioral: Training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Training	Behavioral		Training Group 1 Training Group 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from Baseline at 1 and 3 months in Balance Tests score		Baseline, 1 month post-test, 3 months post-test
Change from Baseline at 1 and 3 months in Spatial Orientation Tests score		Baseline, 1 month post-test, 3 months post-test
Change from Baseline at 1 and 3 months in voxel-wise morphometric brain analysis		Baseline, 1 month post-test, 3 months post-test

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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...)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Notger Müller, Prof. Dr.	German Center for Neurodegenerative Diseases (DZNE)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
DZNE		Magdeburg	Saxony-Anhalt	39120	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000072458	Orientation, Spatial

Ancestor Terms

ID	Term
D013037	Spatial Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided