Old Age; DebilityNCT04473885
Effects of Perturbation-based Balance Training on Postural Control and Cortical Modulation in Elderly With Fall Risk
A study testing Perturbation-based balance training in people with Old Age; Debility and Fall, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Old Age; Debility, Fall
- What is being tested?
- Perturbation-based balance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Aug 2020to 17 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- With any neurological, mental or cognitive disorders, and orthopedic, pulmonary or cardiac problems that could restrict or preclude their participation in exercise.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Old Age; Debility, Fall
- Being tested
- Perturbation-based balance training
- Keywords
- Perturbation-based balance training, Postural control, Cortical modulation, Elderly
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perturbation-based balance trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Perturbation-based balance training group | Experimental | 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. Receives: Other: Perturbation-based balance training |
| Control group | No intervention | Participants in the control group will remain their regular activity without additional training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limits of Stability
Assessing posture control by Balance Master®
Measured: 15 minutes
Cortical modulation
Assessing brain modulation by Event-Related Desynchronization (ERD) collected by electroencephalogram (EEG)
Measured: 1 hour
Secondary outcomes (3)
Sensory Organization Test
Assessing by Balance Master®
Measured: 15 minutes
Berg Balance Scale
Total score is ranged 0-56, higher scores mean a better outcome.
Measured: 15 minutes
Falls Efficacy Scale International
Total score is ranged 16-64, higher scores mean a better outcome.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start31 Aug 2020
- Primary completion17 May 2021
- Study completion17 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Old Age; DebilityStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ray-Yau Wang, Study chair, National Yang Ming Chiao Tung University, Taiwan, R.O.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473885
- Sponsor's protocol ID
- YM109047F
- Status last verified
- Nov 2021
- First submitted
- 12 Jul 2020
- Last updated
- 22 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Multi-directional Perturbation-based Balance Training on Postural Control and Cortical Modulation in Elderly With Fall Risk
- ClinicalTrials.gov ID
- NCT04473885
- Acronym / sponsor ID
- YM109047F
- Conditions
- Old Age; Debility, Fall
- Keywords
- Perturbation-based balance training, Postural control, Cortical modulation, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 17 May 2021 (actual)
- Study completion
- 17 May 2021 (actual)
- First posted
- 16 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perturbation-based balance training group | Experimental | Other: Perturbation-based balance trainingParticipants 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. |
| Control group | No intervention | –Participants in the control group will remain their regular activity without additional training. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- With any neurological, mental or cognitive disorders, and orthopedic, pulmonary or cardiac problems that could restrict or preclude their participation in exercise.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perturbation-based balance trainingParticipants 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 group |
Primary outcome
Limits of Stability
Time frame: 15 minutes
Assessing posture control by Balance Master®
Cortical modulation
Time frame: 1 hour
Assessing brain modulation by Event-Related Desynchronization (ERD) collected by electroencephalogram (EEG)
3 secondary outcomes
Sensory Organization Test
Time frame: 15 minutes
Berg Balance Scale
Time frame: 15 minutes
Falls Efficacy Scale International
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ray-Yau Wang study chair
National Yang Ming Chiao Tung University, Taiwan, R.O.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perturbation-based balance training in people with Old Age; Debility and Fall, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Limits of Stability (time frame: 15 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021.