Posture Training and Cerebellar Stimulation in Elderly People (P)

November 5, 2019 updated by: National Cheng-Kung University Hospital

Enhancement of Posture Training Effectiveness With Error-enhancing Feedback and Cerebellar Stimulation

Motor learning relies on both feedback and feedforward mechanisms to keep progressive optimization of motor behaviors in a coordinated manner. Error correction based on the fronto-parietal loop is subject to error information inherent within visual feedback. On the other hand, cerebellar activity for restoration of efferent copy involves in operation of feedforward mechanism. Therefore, the amount of error feedback and excitation of cerebellum are keyed to effectiveness of motor learning. Although postural training is of empirical value to prevent falling from the elderly, yet none of previous studies have ever been devoted to improve effectiveness of postural training via manipulations of visual error feedback and cerebellar stimulation.

From the aspect of cognition-motor interaction, the present proposal is a three-year project intended to promote effectiveness of postural training for the elderly. In the first year, feedback-based training benefits from a dynamic postural task under the conditions of different visual size of error feedback (error-reducing feedback, error-enhancing feedback, and fixed error feedback) will be contrasted. In the second year, feedforward-based training benefits from a dynamic postural task by application of cerebellum transcranial electrical stimulation (ctDCS) of different modes (direct current vs. noise vs. sham) will be contrasted. In the third year, the proposal will examine whether postural training with combined approach (error-enhancing feedback and ctDCS) could result in a superior training benefit to those of error-enhancing feedback alone and ctDCS alone approaches. In addition to innovative training intervention, this proposal will make use of current non-linear analyses on EEG signals and postural sway with graph analysis and heading analysis, respectively. It is expected to gain additional insight into behavior and brain mechanisms underlying learning-related changes with the postural training, potentially lending to a more effective training paradigm for postural stability of the elderly.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age above 60 years old healthy older adults without a history of falls.
  • Able to understand and give informed consent.
  • The Mini-Mental State Examination test score above 25-30.
  • Lower limb muscle strength is evaluated as G grade
  • The corrected visual acuity was within the normal range.

Exclusion Criteria:

  • Any known history of mental illness
  • Any neuromuscular or degenerative neurological disease(ex:stroke、SCI、TBI...etc)
  • Any known history of cerebral cerebellar disease or intracranial metal implants.
  • Weak of hearing or wearing a hearing aid

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: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
NO_INTERVENTION: error-enhancing feedback
The project of the first arm was to investigate how visualized error size affects postural training effect of the elderly, with a particular focus on error amplification strategy to optimize training benefits for postural training that favors the use of feedback mechanism on postural control and error correction. All participants were randomly assigned into the control and error amplification groups. The control group was trained to remain static stance on the stabilometer with visual guidance that displayed the target signal and tilting angle of the stabilometer. For the error amplification group, they were trained with the same postural paradigm, except that the visual guidance was virtually manipulated so that the participants visually perceived twice of the execution errors during stabilometer stance. We contrasted training benefits between the two groups after completion of eight training trails of 1 minute.
EXPERIMENTAL: positive cerebellar transcranial stimulation
The project of the second arm was to investigate the training benefits of using combined cerebellar transcranial direct current stimulation and visual error amplification on postural training during static stabilometer stance, in reference to sole visual error amplification. A particular focus was training-related alterations in error correction strategy and underlying cortical plasticity for postural balance.They were randomly assigned into the control (traditional error amplification)and cerebellar transcranial direct current stimulation groups. Both groups were trained to remain static stance on the stabilometer with visual guidance that displayed the target signal and tilting angle of the stabilometer. Under the condition of visual feedback without error amplification, we again contrasted training benefits between the two groups after completion of eight training trails of 1 minute.
Device: cerebellar transcranial stimulation
Feedforward-based training benefits from a dynamic postural task by application of cerebellum transcranial electrical stimulation (ctDCS) of different modes (direct current vs. noise vs. sham) were administered using a one-channel direct current stimulator (NeuroConn DC-Stimulator PlusTM) with study mode enabled for single blinding. Following the baseline trial of posture tracking, participants of three groups were seated in a chair for 20 min to receive either active or sham cerebellar tDCS prior to the posture tracking and transfer test phases.
EXPERIMENTAL: sham cerebellar transcranial stimulation
The project of the third arm was to investigate the training benefits of using combined cerebellar transcranial random current stimulation and visual error amplification on postural training during static stabilometer stance, in reference to sole visual error amplification. A particular focus was training-related alterations in error correction strategy and underlying cortical plasticity for postural balance. All participants were randomly assigned into the control (sham stimulation) and cerebellar transcranial random current stimulation and visual error amplification (ES) groups. Both groups were trained to remain static stance on the stabilometer with visual guidance that displayed the target signal and tilting angle of the stabilometer. Under the condition of visual feedback without error amplification, we again contrasted training benefits between the two groups after completion of eight training trails of 1 minute.
Device: cerebellar transcranial stimulation
Feedforward-based training benefits from a dynamic postural task by application of cerebellum transcranial electrical stimulation (ctDCS) of different modes (direct current vs. noise vs. sham) were administered using a one-channel direct current stimulator (NeuroConn DC-Stimulator PlusTM) with study mode enabled for single blinding. Following the baseline trial of posture tracking, participants of three groups were seated in a chair for 20 min to receive either active or sham cerebellar tDCS prior to the posture tracking and transfer test phases.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Graph theoretical analysis of EEG functional network
Time Frame: through study completion, an average of 1 year
Graph theory will characterize EEG functional connectivity and brain network efficiency regarding to brain mechanisms for practice-related leaning transfer.This project introduced EEG pattern analysis into the posture research project. It is expected to find out the changes in brain network efficiency and functional structure caused by posture training. It is a tool for understanding the neural mechanism of this project.
through study completion, an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
heading analysis of center of pressure
Time Frame: through study completion, an average of 1 year
Trajectories of central of pressure will be analyzed with stabilogram diffusion analysis to reveal behavior mechanisms for practice-related variations in feedback and feedforward process for error corrections.
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Cheng-Kung University Hospital

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 (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 20, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 24, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MOST 105-2314-B-006 -014 -MY3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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