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

Sponsor
National Yang Ming University (Other)
Overall Status
Completed
CT.gov ID
NCT04473885
Collaborator
(none)
14
1
2
8.5
1.6

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Perturbation-based balance training
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Multi-directional Perturbation-based Balance Training on Postural Control and Cortical Modulation in Elderly With Fall Risk
Actual Study Start Date :
Aug 31, 2020
Actual Primary Completion Date :
May 17, 2021
Actual Study Completion Date :
May 17, 2021

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Limits of Stability [15 minutes]

    Assessing posture control by Balance Master®

  2. Cortical modulation [1 hour]

    Assessing brain modulation by Event-Related Desynchronization (ERD) collected by electroencephalogram (EEG)

Secondary Outcome Measures

  1. Sensory Organization Test [15 minutes]

    Assessing by Balance Master®

  2. Berg Balance Scale [15 minutes]

    Total score is ranged 0-56, higher scores mean a better outcome.

  3. Falls Efficacy Scale International [15 minutes]

    Total score is ranged 16-64, higher scores mean a better outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Yang Ming Chiao Tung University Taipei Taiwan 112

Sponsors and Collaborators

  • National Yang Ming University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Yang Ming University
ClinicalTrials.gov Identifier:
NCT04473885
Other Study ID Numbers:
  • YM109047F
First Posted:
Jul 16, 2020
Last Update Posted:
Nov 22, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by National Yang Ming University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 22, 2021