Effects of Perturbation-based Balance Training on Postural Control and Cortical Modulation in Elderly With Fall Risk

November 12, 2021 updated by: National Yang Ming University

Effects of Multi-directional Perturbation-based Balance Training on Postural Control and Cortical Modulation in Elderly With Fall Risk

This is a single-blinded randomized controlled trial with pre- and post- measurements. Forty community-dwelling elderly (age> 65 y/o) with fall risk (defined as functional reach test≦25.4 cm) will be recruited and randomly assigned to experimental group or control group (n=20 for each group). Participants in the experimental group will receive the balance training under perturbation on Balance SystemTM SD, including limits of stability training, maze control training, random control training. The intervention is 40 min/session, 3 sessions/week for 6 weeks. Participants in the control group will remain their regular activity without additional training. The primary outcomes include the limit of stability (LOS) of posture control by Balance Master® and brain modulation by Event-Related Desynchronization (ERD) collected by electroencephalogram (EEG). Secondary outcomes include the sensory organization test (SOT), Berg balance scale (BBS), and falls efficacy scale International (FES-I).

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.

Detailed Description

Background: Falling is one of the common factors affecting the health in older people. It would cause severe consequences and result in decreasing mobility and independent activity of daily living. According to previous study, balance impairment is the frequent factor for fall in elderly. To maintain balance, reactive postural control ability is the key element from falling. It is suggested that perturbation-based balance training can improve reactive balance performance. However, few studies focus on multi-direction perturbation to mimic the perturbation experienced in daily living. Furthermore, the related cortical activity changes after perturbation-based balance training is not known.

Purpose: The purpose of this study is to explore the effects of multi-directional perturbation-based balance training on posture control and brain modulation in elderly with fall risk.

Methods: This is a single-blinded randomized controlled trial with pre- and post- measurements. Forty community-dwelling elderly (age> 65 y/o) with fall risk (defined as functional reach test≦25.4 cm) will be recruited and randomly assigned to experimental group or control group (n=20 for each group). Participants in the experimental group will receive the balance training under perturbation on Balance SystemTM SD, including limits of stability training, maze control training, random control training. The intervention is 40 min/session, 3 sessions/week for 6 weeks. Participants in the control group will remain their regular activity without additional training. The primary outcomes include the limit of stability (LOS) of posture control by Balance Master® and brain modulation by Event-Related Desynchronization (ERD) collected by electroencephalogram (EEG). Secondary outcomes include the sensory organization test (SOT), Berg balance scale (BBS), and falls efficacy scale International (FES-I). Independent t test and Chi-square test are used for baseline characteristic analysis. All outcomes will be analyzed by repeated measures two-way ANOVA with Tukey post hoc test for within-group and between-group comparisons. Statistical significance is set at p<0.05.

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.
14

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 Locations

  • Taiwan
      • Taipei, Taiwan, 112
        • National Yang Ming Chiao Tung University

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Over 65 y/o community-dwelling elderly with fall risk (Functional reach test ≦25.4 cm).
  • Mini-Mental State Examination score (MMSE) ≧ 24.
  • Able to walk independently without assistance at least 10 meters.

Exclusion Criteria:

  • With any neurological, mental or cognitive disorders, and orthopedic, pulmonary or cardiac problems that could restrict or preclude their participation in exercise.

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: Parallel Assignment
  • 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.
Experimental: Perturbation-based balance training group
Participants in the experimental group will receive the balance training under perturbation on Balance SystemTM SD, including limits of stability training, maze control training, random control training. The intervention is 40 min/session, 3 sessions/week for 6 weeks.
Other: Perturbation-based balance training
Participants in the experimental group will receive the balance training under perturbation on Balance SystemTM SD, including limits of stability training, maze control training, random control training. The intervention is 40 min/session, 3 sessions/week for 6 weeks.
No Intervention: Control group
Participants in the control group will remain their regular activity without additional training.

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
Limits of Stability
Time Frame: 15 minutes
Assessing posture control by Balance Master®
15 minutes
Cortical modulation
Time Frame: 1 hour
Assessing brain modulation by Event-Related Desynchronization (ERD) collected by electroencephalogram (EEG)
1 hour

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
Sensory Organization Test
Time Frame: 15 minutes
Assessing by Balance Master®
15 minutes
Berg Balance Scale
Time Frame: 15 minutes
Total score is ranged 0-56, higher scores mean a better outcome.
15 minutes
Falls Efficacy Scale International
Time Frame: 15 minutes
Total score is ranged 16-64, higher scores mean a better outcome.
15 minutes

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 Yang Ming University

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: Ray-Yau Wang, National Yang Ming Chiao Tung University, Taiwan, R.O.C.

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 31, 2020

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.
May 17, 2021

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.
May 17, 2021

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).
July 12, 2020

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.
July 12, 2020

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.
July 16, 2020

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 22, 2021

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 12, 2021

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.
November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • YM109047F

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

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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