Effects of Perturbation-based Balance Training on Postural Control and Cortical Modulation in Elderly With Fall Risk
Primary Purpose
Old Age; Debility, Fall
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Perturbation-based balance training
Sponsored by
About this trial
This is an interventional treatment trial for Old Age; Debility focused on measuring Perturbation-based balance training, Postural control, Cortical modulation, Elderly
Eligibility Criteria
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.
Sites / Locations
- National Yang Ming Chiao Tung University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Perturbation-based balance training group
Control group
Arm Description
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.
Outcomes
Primary Outcome Measures
Limits of Stability
Assessing posture control by Balance Master®
Cortical modulation
Assessing brain modulation by Event-Related Desynchronization (ERD) collected by electroencephalogram (EEG)
Secondary Outcome Measures
Sensory Organization Test
Assessing by Balance Master®
Berg Balance Scale
Total score is ranged 0-56, higher scores mean a better outcome.
Falls Efficacy Scale International
Total score is ranged 16-64, higher scores mean a better outcome.
Full Information
NCT ID
NCT04473885
First Posted
July 12, 2020
Last Updated
November 12, 2021
Sponsor
National Yang Ming University
1. Study Identification
Unique Protocol Identification Number
NCT04473885
Brief Title
Effects of Perturbation-based Balance Training on Postural Control and Cortical Modulation in Elderly With Fall Risk
Official Title
Effects of Multi-directional Perturbation-based Balance Training on Postural Control and Cortical Modulation in Elderly With Fall Risk
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
August 31, 2020 (Actual)
Primary Completion Date
May 17, 2021 (Actual)
Study Completion Date
May 17, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Yang Ming University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Old Age; Debility, Fall
Keywords
Perturbation-based balance training, Postural control, Cortical modulation, Elderly
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Perturbation-based balance training group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants in the control group will remain their regular activity without additional training.
Intervention Type
Other
Intervention Name(s)
Perturbation-based balance training
Intervention Description
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 Measure Information:
Title
Limits of Stability
Description
Assessing posture control by Balance Master®
Time Frame
15 minutes
Title
Cortical modulation
Description
Assessing brain modulation by Event-Related Desynchronization (ERD) collected by electroencephalogram (EEG)
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Sensory Organization Test
Description
Assessing by Balance Master®
Time Frame
15 minutes
Title
Berg Balance Scale
Description
Total score is ranged 0-56, higher scores mean a better outcome.
Time Frame
15 minutes
Title
Falls Efficacy Scale International
Description
Total score is ranged 16-64, higher scores mean a better outcome.
Time Frame
15 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ray-Yau Wang
Organizational Affiliation
National Yang Ming Chiao Tung University, Taiwan, R.O.C.
Official's Role
Study Chair
Facility Information:
Facility Name
National Yang Ming Chiao Tung University
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Perturbation-based Balance Training on Postural Control and Cortical Modulation in Elderly With Fall Risk
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