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

Not Applicable

Completed

• Conditions: Old Age; Debility; Fall
• Interventions: Other: Perturbation-based balance training

• Registration Number: NCT04473885
• Lead Sponsor: National Yang Ming Chiao Tung University

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).

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 Timeline

• Study First Submitted: 2020-07-12
• Study First Submitted QC: 2020-07-12
• Study First Posted: 2020-07-16
• Study Start: 2020-08-31
• Primary Completion: 2021-05-17
• Study Completion: 2021-05-17
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-12
• Last Update Posted: 2021-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Perturbation-based balance training group	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Yang Ming Chiao Tung University; 🇨🇳 Taipei, Taiwan