NCT04154397

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 6, 2019

Completed
Last Updated

November 6, 2019

Status Verified

October 1, 2019

Enrollment Period

3.7 years

First QC Date

October 28, 2019

Last Update Submit

November 5, 2019

Conditions

Keywords

Motor learningCerebellum transcranial electrical stimulationPostural balanceError feedbackElectroencephalographyElderly

Outcome Measures

Primary Outcomes (1)

  • Graph theoretical analysis of EEG functional network

    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 Outcomes (1)

  • heading analysis of center of pressure

    through study completion, an average of 1 year

Study Arms (3)

error-enhancing feedback

NO INTERVENTION

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.

positive cerebellar transcranial stimulation

EXPERIMENTAL

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

sham cerebellar transcranial stimulation

EXPERIMENTAL

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

Interventions

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.

positive cerebellar transcranial stimulationsham cerebellar transcranial stimulation

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Hwang Ing-Shiou, Phd

    NCKU, Institute of Allied Health Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2019

First Posted

November 6, 2019

Study Start

May 20, 2015

Primary Completion

January 24, 2019

Study Completion

September 30, 2019

Last Updated

November 6, 2019

Record last verified: 2019-10