Towards an Objectivation of the Therapeutic Effect of a Rocking Movement (BAL-EASE)

September 4, 2020 updated by: Centre Hospitalier Universitaire de Besancon

Objectivating the Therapeutic Effect of a Rocking Movement by High Density Electroencephalography

The study evaluates the benefits of a rocking movement on well-being and attention, through high-density electroencephalography recordings. The effect of the rocking movement is compared to a seated position and a lying position.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Right handed
  • Informed consent

Exclusion Criteria:

  • Pregnancy
  • subjects with analgesic treatment
  • subjects dependent on psychotropic substances

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Rocking movement
Participant is lying in a hammock with a rocking motion. Cerebral measurements from high-density electroencephalography while standard and deviant sounds are presented to the participant.
Device: high-density electroencephalography
Cerebral measurements from high-density electroencephalography while standard and deviant sounds are presented to the participant.
ACTIVE_COMPARATOR: Lying position
Participant is lying in a hammock with no rocking motion. Cerebral measurements from high-density electroencephalography while standard and deviant sounds are presented to the participant.
Device: high-density electroencephalography
Cerebral measurements from high-density electroencephalography while standard and deviant sounds are presented to the participant.
ACTIVE_COMPARATOR: Seated position
Participant is sitting on a chair. Cerebral measurements from high-density electroencephalography while standard and deviant sounds are presented to the participant.
Device: high-density electroencephalography
Cerebral measurements from high-density electroencephalography while standard and deviant sounds are presented to the participant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference of amplitude between standard and deviant sounds
Time Frame: 20 minutes
The amplitude of the mismatch negativity (corresponding to the difference between standard and deviant sounds) will be measured by electroencephalography.
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (ACTUAL)

October 1, 2017

Study Completion (ACTUAL)

October 1, 2017

Study Registration Dates

First Submitted

July 13, 2016

First Submitted That Met QC Criteria

July 13, 2016

First Posted (ESTIMATE)

July 15, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 7, 2020

Last Update Submitted That Met QC Criteria

September 4, 2020

Last Verified

July 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • API/2012/27

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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