AgingPNCT04137952
Short-term Postural Training for Older Adults
A study testing size of error visual feedback in people with Aging and Balance, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
Generalization refers to skill transfer under various working spaces following motor practice. The extent of generalization effect links causal to in-depth recognition of error properties during motor practice. Idiom says "imperfect practice makes perfect". Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- What is being tested?
- size of error visual feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2019to 30 Dec 2022
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age above 60 years old healthy older adults without a history of falls.
- Able to understand and give informed consent.
- The Mini-Mental State Examination test score above 25-30.
- Lower limb muscle strength is evaluated as G grade
- The corrected visual acuity was within the normal range.
Who cannot join
- Any known history of mental illness
- Any neuromuscular or degenerative neurological disease(ex:stroke、SCI、TBI...etc)
- Any known history of cerebral cerebellar disease or intracranial metal implants.
- Weak of hearing or wearing a hearing aid
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Chen Kong University Hospital
Taian, Eastern District, 701
About this study
Official title: The Use of Neuro-cognitive Strategies to Power Generalization Effect After Short-term Postural Training for Older Adults
Generalization refers to skill transfer under various working spaces following motor practice. The extent of generalization effect links causal to in-depth recognition of error properties during motor practice. Idiom says "imperfect practice makes perfect". It could be beneficial for the elderly to gain superior capacity of balance transfer skill under the short-term productive failure learning environments. In contrast to traditional visual feedback that uses error avoidance training to optimize target balance task, the present 3-year proposal is to propose three potential neuro-cognitive strategies to improve motor skill transfer following stabilometer training. The strategies are expected to enhance opportunities of error experience and motor exploration via modified visual feedback, underlying facilitations of attentional resource and error-related neural networks. In the first year, the neuro-cognitive strategy for balance practice is progressive augmentation of visual error size to improve balance skill transfer. In the second year, the neuro-cognitive strategy for balance practice is visual feedback with virtual uncertainness of motor goal. In the third year, the neuro-cognitive strategy for balance practice is stroboscopic vision. EEG and central of pressure will be processed with non-linear approaches. Graph theory will characterize EEG functional connectivity and brain network efficiency regarding to brain mechanisms for practice-related leaning transfer. Trajectories of central of pressure will be analyzed with stabilogram diffusion analysis to reveal behavior mechanisms for practice-related variations in feedback and feedforward process for error corrections.
- Being tested
- size of error visual feedback
- Keywords
- Posture training, Motor generalization, Aging, Cognition, High-density electroencephalography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
size of error visual feedbackBehavioural
Also called virtual uncertainness of motor goals, stroboscopic vision
The strategies are expected to enhance opportunities of error experience and motor exploration via modified visual feedback, underlying facilitations of attentional resource and error-related neural networks.
| Study group | Role | What they receive |
|---|---|---|
| deterministic visual error gain | Experimental | Day1(Pretest):
1. stabilometer stance, 3 times/1 min
2. air pillow stance, 3 time/30 sec
3. poture-supraposture dual task, 3 times/1 min
Day2 to Day5:
1. Exp.group:27 times of posture tracking with high visual error gain.
2. Control group:27 times of posture training with normal visual error gain.
Day6 (Posttest):
1. stabilometer stance, 3 times/1 min
2. air pillow stance, 3 time/30 sec
3. poture-supraposture dual task, 3 times/1 min Receives: Behavioral: size of error visual feedback |
| stochastic visual noise | Experimental | Day1(Pretest):
1. stabilometer stance, 3 times/1 min
2. air pillow stance, 3 time/30 sec
3. poture-supraposture dual task, 3 times/1 min
Day2 to Day5:
1. Exp.group A:27 times of posture training with posture tracking signal-to-noise ratio=2:1.
2. Exp.group B:27 times of posture training with posture tracking signal-to-noise ratio=4:1.
3. Control group:27 times of posture training with normal visual error gain.
Day6(Posttest):
1. stabilometer stance, 3 times/1 min
2. air pillow stance, 3 time/30 sec
3. poture-supraposture dual task, 3 times/1 min Receives: Behavioral: size of error visual feedback |
| intermittent visual gain | Experimental | Day1 (Pretest):
1. stabilometer stance with wearing flash glasses (low frequency with opaque ratio 50%), 4 times/45 sec
2. stabilometer stance with wearing flash glasses (high frequency with opaque ratio 50%), 4 times/45 sec.
3. stabilometer stance with wearing flash glasses (clear), 4 times/45 sec
4. air pillow stance, 8 times/1 min
Day2 (training section):
1. Exp. group:Posture tracking with wearing flash glasses (low frequency with opaque ratio 50%), 12 times/45 sec.
2. Control group:Posture tracking with wearing flash glasses (clear), 12 times/45 sec.
Day3 (Posttest):
1. stabilometer stance with wearing flash glasses (low frequency with opaque ratio 50%), 4 times/45 sec
2. stabilometer stance with wearing flash glasses (high frequency with opaque ratio 50%), 4 times/45 sec
3. stabilometer stance with wearing flash glasses (clear), 4 times/45 sec
4. air pillow stance, 8 times/1 min Receives: Behavioral: size of error visual feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG graph analysis
Graph theory will characterize EEG functional connectivity and brain network efficiency regarding to brain mechanisms for practice-related leaning transfer.
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
stabilogram diffusion analysis of central of pressure
Trajectories of central of pressure will be analyzed with stabilogram diffusion analysis to reveal behavior mechanisms for practice-related variations in feedback and feedforward process for error corrections.
Measured: through study completion, an average of 1 year
root mean sqaure error of stabilometer
The root-mean-square value of the tracking trajectory of stabilometer and the target signal.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start1 Aug 2019
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Sponsor
- Investigators
- Hwang Ing-Shiou, Phd, Study chair, NCKU, Institute of Allied Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04137952
- Sponsor's protocol ID
- MOST 108-2314-B-006-071 -
- Acronym
- P
- Status last verified
- Sep 2024
- First submitted
- 20 Oct 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Neuro-cognitive Strategies to Power Generalization Effect After Short-term Postural Training for Older Adults
- ClinicalTrials.gov ID
- NCT04137952
- Acronym / sponsor ID
- P / MOST 108-2314-B-006-071 -
- Keywords
- Posture training, Motor generalization, Aging, Cognition, High-density electroencephalography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 24 Oct 2019 (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.
Generalization refers to skill transfer under various working spaces following motor practice. The extent of generalization effect links causal to in-depth recognition of error properties during motor practice. Idiom says "imperfect practice makes perfect". It could be beneficial for the elderly to gain superior capacity of balance transfer skill under the short-term productive failure learning environments. In contrast to traditional visual feedback that uses error avoidance training to optimize target balance task, the present 3-year proposal is to propose three potential neuro-cognitive strategies to improve motor skill transfer following stabilometer training. The strategies are expected to enhance opportunities of error experience and motor exploration via modified visual feedback, underlying facilitations of attentional resource and error-related neural networks. In the first year, the neuro-cognitive strategy for balance practice is progressive augmentation of visual error size to improve balance skill transfer. In the second year, the neuro-cognitive strategy for balance practice is visual feedback with virtual uncertainness of motor goal. In the third year, the neuro-cognitive strategy for balance practice is stroboscopic vision. EEG and central of pressure will be processed with non-linear approaches. Graph theory will characterize EEG functional connectivity and brain network efficiency regarding to brain mechanisms for practice-related leaning transfer. Trajectories of central of pressure will be analyzed with stabilogram diffusion analysis to reveal behavior mechanisms for practice-related variations in feedback and feedforward process for error corrections.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| deterministic visual error gain | Experimental | Behavioral: size of error visual feedbackDay1(Pretest): 1. stabilometer stance, 3 times/1 min 2. air pillow stance, 3 time/30 sec 3. poture-supraposture dual task, 3 times/1 min Day2 to Day5: 1. Exp.group:27 times of posture tracking with high visual error gain. 2. Control group:27 times of posture training with normal visual error gain. Day6 (Posttest): 1. stabilometer stance, 3 times/1 min 2. air pillow stance, 3 time/30 sec 3. poture-supraposture dual task, 3 times/1 min |
| stochastic visual noise | Experimental | Behavioral: size of error visual feedbackDay1(Pretest): 1. stabilometer stance, 3 times/1 min 2. air pillow stance, 3 time/30 sec 3. poture-supraposture dual task, 3 times/1 min Day2 to Day5: 1. Exp.group A:27 times of posture training with posture tracking signal-to-noise ratio=2:1. 2. Exp.group B:27 times of posture training with posture tracking signal-to-noise ratio=4:1. 3. Control group:27 times of posture training with normal visual error gain. Day6(Posttest): 1. stabilometer stance, 3 times/1 min 2. air pillow stance, 3 time/30 sec 3. poture-supraposture dual task, 3 times/1 min |
| intermittent visual gain | Experimental | Behavioral: size of error visual feedbackDay1 (Pretest): 1. stabilometer stance with wearing flash glasses (low frequency with opaque ratio 50%), 4 times/45 sec 2. stabilometer stance with wearing flash glasses (high frequency with opaque ratio 50%), 4 times/45 sec. 3. stabilometer stance with wearing flash glasses (clear), 4 times/45 sec 4. air pillow stance, 8 times/1 min Day2 (training section): 1. Exp. group:Posture tracking with wearing flash glasses (low frequency with opaque ratio 50%), 12 times/45 sec. 2. Control group:Posture tracking with wearing flash glasses (clear), 12 times/45 sec. Day3 (Posttest): 1. stabilometer stance with wearing flash glasses (low frequency with opaque ratio 50%), 4 times/45 sec 2. stabilometer stance with wearing flash glasses (high frequency with opaque ratio 50%), 4 times/45 sec 3. stabilometer stance with wearing flash glasses (clear), 4 times/45 sec 4. air pillow stance, 8 times/1 min |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age above 60 years old healthy older adults without a history of falls.
- Able to understand and give informed consent.
- The Mini-Mental State Examination test score above 25-30.
- Lower limb muscle strength is evaluated as G grade
- The corrected visual acuity was within the normal range.
Key exclusion criteria (4 listed)
- Any known history of mental illness
- Any neuromuscular or degenerative neurological disease(ex:stroke、SCI、TBI...etc)
- Any known history of cerebral cerebellar disease or intracranial metal implants.
- Weak of hearing or wearing a hearing aid
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 |
|---|---|---|
| size of error visual feedbackAlso: virtual uncertainness of motor goals, stroboscopic visionThe strategies are expected to enhance opportunities of error experience and motor exploration via modified visual feedback, underlying facilitations of attentional resource and error-related neural networks. | Behavioural | deterministic visual error gain, intermittent visual gain, stochastic visual noise |
Primary outcome
EEG graph analysis
Time frame: through study completion, an average of 1 year
Graph theory will characterize EEG functional connectivity and brain network efficiency regarding to brain mechanisms for practice-related leaning transfer.
2 secondary outcomes
stabilogram diffusion analysis of central of pressure
Time frame: through study completion, an average of 1 year
root mean sqaure error of stabilometer
Time frame: through study completion, an average of 1 year
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 19 Sep 2024.
- 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.
Hwang Ing-Shiou, Phd study chair
NCKU, Institute of Allied Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing size of error visual feedback in people with Aging and Balance, run by National Cheng-Kung University Hospital 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 5 inclusion and 4 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 19 Sep 2024. 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?
EEG graph analysis (time frame: through study completion, an average of 1 year). 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 19 Sep 2024.