ParkinsonNCT02539446
Suprapostural Attention Focus and Postural Difficulty on H-reflex and Brain Activity: Aging and Parkinson's Disease
A study testing stable condition, unstable condition and attentional focus in people with Parkinson, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial summary
Inherent with intricate allocation of brain resource and attention shift, postural-suprapostural task is defined as postural control takes place while the other concurrent task is being performed. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson
- What is being tested?
- stable condition, unstable condition and attentional focus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesTaiwan
- Study dates
- Oct 2014to Sep 2016
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Independent standing balance on air pillow at least 20 sec
- No neurologic or orthopedic disorder
Who cannot join
- Had relative experience before
- Pregnant women
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
National Taiwan University Hospital
Taipei, 100
School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
Taipei, 100
About this study
Official title: The Effects of Suprapostural Attention Focus and Postural Difficulty on H-reflex and Brain Activity: Aging and Parkinson's Disease
Inherent with intricate allocation of brain resource and attention shift, postural-suprapostural task is defined as postural control takes place while the other concurrent task is being performed. Recent studies have indicated that attentional focusing alters attention allocation in the brain as well as motor performance of a postural-suprapostural task. Also, most studies have demonstrated benefits of inducing an external focus relative to internal focus for motor performance. However, postural difficulty might be a critical factor for choosing an appropriate focusing strategy, and the strategy used in a particular difficulty level do not always generalize to other difficulty levels. Besides, despite a lot of studies have been done, current findings are confined to behavioral observations in young healthy adults for lacking direct neural evidence. With the uses of H-reflex, event-related potential and behavioral measures, the purpose of the 3-year research project is to investigate the differences in performance quality and intrinsic neural mechanisms of a postural-suprapostural task for older adults and patients with Parkinson's disease, by adopting external and internal strategies for suprapostural task under different posture difficulties. In the first year, the investigators will characterize suprapostural focusing effect on reciprocity of a postural-suprapostural task, with a special focus on modulation of motoneuron excitability in sitting and standing posture for healthy young and older adults using H-reflex technique. In the second year, the adaptive selection of suprapostural focusing strategy will be investigated for patients with Parkinson's disease by varying the standing surface (stable/unstable surface). In the third year, the investigators will investigate suprapostural focusing effect on brain resource allocation for patients with Parkinson's disease, in light of event-related potential and movement-related potential. The present project is expected to have significant contributions not only to gain a better insight to neural correlates of concurrent postural and motor suprapostural tasks with internal/external focusing strategy under different posture difficulty, but to optimize treatment strategy for older adults and patients with Parkinson's disease with balance or multi-tasking disturbances.
- Conditions
- Parkinson
- Being tested
- stable condition, unstable condition, attentional focus
- Keywords
- Aging, External focus, Internal focus, Attention, Posture balance, Parkinson's disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stable conditionBehavioural
unstable conditionBehavioural
attentional focusBehavioural
Also called internal focus, external focus
| Study group | Role | What they receive |
|---|---|---|
| stable condition & attentional focus | Other | for measure the relationships between task difficulty and attentional focus on supraposture Receives: Behavioral: stable condition; Behavioral: attentional focus |
| unstable condition & attentional focus | Other | for measure the relationships between task difficulty and attentional focus on supraposture Receives: Behavioral: unstable condition; Behavioral: attentional focus |
What is being measured
The primary outcome is the main question the study is designed to answer.
H-reflex analysis
The value of soleus H/Mmax ratio is measured as the motoneuron excitability
Measured: 1 week
Secondary outcomes (2)
EMG analysis
The root mean square value of right biceps EMG is measured as the muscle activity
Measured: 1 week
postural sway analysis
The root mean square value of center of pressure in anterior-posterior and medial-lateral directions are used as the postural performance
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study startOct 2014
- Primary completionOct 2014
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ParkinsonStudies of the same condition, open and under way.
- More trials run by National Taiwan 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cheng-Ya Huang, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02539446
- Sponsor's protocol ID
- 201312077RINC
- Status last verified
- Oct 2016
- First submitted
- 21 Oct 2014
- Last updated
- 16 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Yu SH, Wu RM, Huang CY. Attentional Resource Associated With Visual Feedback on a Postural Dual Task in Parkinson's Disease. Neurorehabil Neural Repair. 2020 Oct;34(10):891-903. doi: 10.1177/1545968320948071. Epub 2020 Aug 24.
PubMed 32830603Huang CY, Chen YA, Hwang IS, Wu RM. Improving Dual-Task Control With a Posture-Second Strategy in Early-Stage Parkinson Disease. Arch Phys Med Rehabil. 2018 Aug;99(8):1540-1546.e2. doi: 10.1016/j.apmr.2018.02.013. Epub 2018 Mar 31.
PubMed 29608901
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Suprapostural Attention Focus and Postural Difficulty on H-reflex and Brain Activity: Aging and Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02539446
- Acronym / sponsor ID
- 201312077RINC
- Conditions
- Parkinson
- Keywords
- Aging, External focus, Internal focus, Attention, Posture balance, Parkinson's disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 3 Sep 2015 (estimated)
- 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.
Inherent with intricate allocation of brain resource and attention shift, postural-suprapostural task is defined as postural control takes place while the other concurrent task is being performed. Recent studies have indicated that attentional focusing alters attention allocation in the brain as well as motor performance of a postural-suprapostural task. Also, most studies have demonstrated benefits of inducing an external focus relative to internal focus for motor performance. However, postural difficulty might be a critical factor for choosing an appropriate focusing strategy, and the strategy used in a particular difficulty level do not always generalize to other difficulty levels. Besides, despite a lot of studies have been done, current findings are confined to behavioral observations in young healthy adults for lacking direct neural evidence. With the uses of H-reflex, event-related potential and behavioral measures, the purpose of the 3-year research project is to investigate the differences in performance quality and intrinsic neural mechanisms of a postural-suprapostural task for older adults and patients with Parkinson's disease, by adopting external and internal strategies for suprapostural task under different posture difficulties. In the first year, the investigators will characterize suprapostural focusing effect on reciprocity of a postural-suprapostural task, with a special focus on modulation of motoneuron excitability in sitting and standing posture for healthy young and older adults using H-reflex technique. In the second year, the adaptive selection of suprapostural focusing strategy will be investigated for patients with Parkinson's disease by varying the standing surface (stable/unstable surface). In the third year, the investigators will investigate suprapostural focusing effect on brain resource allocation for patients with Parkinson's disease, in light of event-related potential and movement-related potential. The present project is expected to have significant contributions not only to gain a better insight to neural correlates of concurrent postural and motor suprapostural tasks with internal/external focusing strategy under different posture difficulty, but to optimize treatment strategy for older adults and patients with Parkinson's disease with balance or multi-tasking disturbances.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stable condition & attentional focus | Other | Behavioral: stable condition, Behavioral: attentional focusfor measure the relationships between task difficulty and attentional focus on supraposture |
| unstable condition & attentional focus | Other | Behavioral: unstable condition, Behavioral: attentional focusfor measure the relationships between task difficulty and attentional focus on supraposture |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Independent standing balance on air pillow at least 20 sec
- No neurologic or orthopedic disorder
Key exclusion criteria (2 listed)
- Had relative experience before
- Pregnant women
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 |
|---|---|---|
| stable condition | Behavioural | stable condition & attentional focus |
| unstable condition | Behavioural | unstable condition & attentional focus |
| attentional focusAlso: internal focus, external focus | Behavioural | stable condition & attentional focus, unstable condition & attentional focus |
Primary outcome
H-reflex analysis
Time frame: 1 week
The value of soleus H/Mmax ratio is measured as the motoneuron excitability
2 secondary outcomes
EMG analysis
Time frame: 1 week
postural sway analysis
Time frame: 1 week
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 16 Dec 2019.
- Derived from this study: PubMed 32830603Yu SH, Wu RM, Huang CY. Attentional Resource Associated With Visual Feedback on a Postural Dual Task in Parkinson's Disease. Neurorehabil Neural Repair. 2020 Oct;34(10):891-903. doi: 10.1177/1545968320948071. Epub 2020 Aug 24.
- Derived from this study: PubMed 29608901Huang CY, Chen YA, Hwang IS, Wu RM. Improving Dual-Task Control With a Posture-Second Strategy in Early-Stage Parkinson Disease. Arch Phys Med Rehabil. 2018 Aug;99(8):1540-1546.e2. doi: 10.1016/j.apmr.2018.02.013. Epub 2018 Mar 31.
- 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.
Cheng-Ya Huang principal investigator
National Taiwan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stable condition, unstable condition and attentional focus in people with Parkinson, run by National Taiwan University Hospital at 2 sites 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 2 inclusion and 2 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 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
H-reflex analysis (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02539446, which also lists 2 linked publications.
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 16 Dec 2019.