Short-term Postural Training for Older Adults (P)

September 12, 2024 updated by: National Cheng-Kung University Hospital

The Use of Neuro-cognitive Strategies to Power Generalization Effect After Short-term Postural Training for Older Adults

Generalization refers to skill transfer under various working spaces following motor practice. The extent of generalization effect links causal to in-depth recognition of error properties during motor practice. Idiom says "imperfect practice makes perfect". It could be beneficial for the elderly to gain superior capacity of balance transfer skill under the short-term productive failure learning environments. In contrast to traditional visual feedback that uses error avoidance training to optimize target balance task, the present 3-year proposal is to propose three potential neuro-cognitive strategies to improve motor skill transfer following stabilometer training. The strategies are expected to enhance opportunities of error experience and motor exploration via modified visual feedback, underlying facilitations of attentional resource and error-related neural networks. In the first year, the neuro-cognitive strategy for balance practice is progressive augmentation of visual error size to improve balance skill transfer. In the second year, the neuro-cognitive strategy for balance practice is visual feedback with virtual uncertainness of motor goal. In the third year, the neuro-cognitive strategy for balance practice is stroboscopic vision. EEG and central of pressure will be processed with non-linear approaches. Graph theory will characterize EEG functional connectivity and brain network efficiency regarding to brain mechanisms for practice-related leaning transfer. 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.

Study Overview

Status

Status

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

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

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.
150

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Taiwan
    • Eastern District
      • Taian, Eastern District, Taiwan, 701
        • National Chen Kong University Hospital

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

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 Assignment
  • Masking: None (Open Label)

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.
Experimental: deterministic visual error gain

Day1(Pretest):

  1. stabilometer stance, 3 times/1 min
  2. air pillow stance, 3 time/30 sec
  3. poture-supraposture dual task, 3 times/1 min

Day2 to Day5:

  1. Exp.group:27 times of posture tracking with high visual error gain.
  2. Control group:27 times of posture training with normal visual error gain.

Day6 (Posttest):

  1. stabilometer stance, 3 times/1 min
  2. air pillow stance, 3 time/30 sec
  3. poture-supraposture dual task, 3 times/1 min
Behavioral: size of error visual feedback
The strategies are expected to enhance opportunities of error experience and motor exploration via modified visual feedback, underlying facilitations of attentional resource and error-related neural networks.
Other Names:
  • virtual uncertainness of motor goals
  • stroboscopic vision
Experimental: stochastic visual noise

Day1(Pretest):

  1. stabilometer stance, 3 times/1 min
  2. air pillow stance, 3 time/30 sec
  3. poture-supraposture dual task, 3 times/1 min

Day2 to Day5:

  1. Exp.group A:27 times of posture training with posture tracking signal-to-noise ratio=2:1.
  2. Exp.group B:27 times of posture training with posture tracking signal-to-noise ratio=4:1.
  3. Control group:27 times of posture training with normal visual error gain.

Day6(Posttest):

  1. stabilometer stance, 3 times/1 min
  2. air pillow stance, 3 time/30 sec
  3. poture-supraposture dual task, 3 times/1 min
Behavioral: size of error visual feedback
The strategies are expected to enhance opportunities of error experience and motor exploration via modified visual feedback, underlying facilitations of attentional resource and error-related neural networks.
Other Names:
  • virtual uncertainness of motor goals
  • stroboscopic vision
Experimental: intermittent visual gain

Day1 (Pretest):

  1. stabilometer stance with wearing flash glasses (low frequency with opaque ratio 50%), 4 times/45 sec
  2. stabilometer stance with wearing flash glasses (high frequency with opaque ratio 50%), 4 times/45 sec.
  3. stabilometer stance with wearing flash glasses (clear), 4 times/45 sec
  4. air pillow stance, 8 times/1 min

Day2 (training section):

  1. Exp. group:Posture tracking with wearing flash glasses (low frequency with opaque ratio 50%), 12 times/45 sec.
  2. Control group:Posture tracking with wearing flash glasses (clear), 12 times/45 sec.

Day3 (Posttest):

  1. stabilometer stance with wearing flash glasses (low frequency with opaque ratio 50%), 4 times/45 sec
  2. stabilometer stance with wearing flash glasses (high frequency with opaque ratio 50%), 4 times/45 sec
  3. stabilometer stance with wearing flash glasses (clear), 4 times/45 sec
  4. air pillow stance, 8 times/1 min
Behavioral: size of error visual feedback
The strategies are expected to enhance opportunities of error experience and motor exploration via modified visual feedback, underlying facilitations of attentional resource and error-related neural networks.
Other Names:
  • virtual uncertainness of motor goals
  • stroboscopic vision

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
EEG graph analysis
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.
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
stabilogram diffusion analysis of central 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
root mean sqaure error of stabilometer
Time Frame: through study completion, an average of 1 year
The root-mean-square value of the tracking trajectory of stabilometer and the target signal.
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

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministry of Science and Technology, Taiwan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Hwang Ing-Shiou, Phd, NCKU, Institute of Allied Health Sciences

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.
August 1, 2019

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.
December 30, 2022

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.
December 30, 2022

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 20, 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.
October 22, 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.
October 24, 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.
September 19, 2024

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.
September 12, 2024

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.
September 1, 2024

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 108-2314-B-006-071 -

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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