NCT03056430

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 17, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

July 23, 2020

Status Verified

March 1, 2018

Enrollment Period

4 years

First QC Date

December 27, 2016

Last Update Submit

July 21, 2020

Conditions

Spatial OrientationBalance

Keywords

MRI, Neuroplasticity, Balance, Spatial orientation, Hippocampus, Slacklining

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Training Group 1

EXPERIMENTAL

Slackline training

Behavioral: Training

Training Group 2

EXPERIMENTAL

Slackline training

Behavioral: Training

Interventions

TrainingBEHAVIORAL
Training Group 1Training Group 2

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • No previous slacklining or related experience, 18-30 years of age, good or corrected to good vision

You may not qualify if:

  • Musculoskeletal and nervous system injuries/diseases that significantly reduce one's ability to perform slacklining training, systemic diseases (cardiovascular, gastrointestinal, metabolic...)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DZNE

Magdeburg, Saxony-Anhalt, 39120, Germany

Location

MeSH Terms

Conditions

Orientation, Spatial

Condition Hierarchy (Ancestors)

Spatial BehaviorBehavior

Study Officials

  • Notger Müller, Prof. Dr.

    German Center for Neurodegenerative Diseases (DZNE)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: Repeated-measures, 2 groups \* 2 timepoints
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2016

First Posted

February 17, 2017

Study Start

January 1, 2016

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

July 23, 2020

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)