Parkinson DiseaseNCT03895125
The Learning Effects of Attentional Strategy on Dual-task Walking in Patients With Parkinson's Disease: Behavioral Performance and Neural Plasticity
A study testing [year1] dual-task training with task priority strategy and [year2-3] dual-task training with internal and external focus in people with Parkinson Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
[year1] 1. To compare the effects of dual-task training with two different task priority instruction in people with Parkinson's disease and healthy controls on dual-task weight shifting performances. 2. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- [year1] dual-task training with task priority strategy and [year2-3] dual-task training with internal and external focus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Mar 2019to 12 Feb 2020
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For people with Parkinson's disease
- modified Hoehn \& Yahr stage 2-3
- without dementia and able to follow instructions
- For healthy controls
- age and gender matched healthy subjects as control group
Who cannot join
- MMSE < 26
- with other disease that may influence balance ability
- with marked action and postural tremor
- [year2-3] inclusion criteria:
- idiopathic Parkinson's disease
- modified Hoehn \& Yahr stage 2-3
Show all 9Show fewer
- without marked action or postural tremor
- MMSE < 26
- with other disease that may influence balance ability
Trial locations and contacts
1 site in 1 country.
About this study
[year1]
- To compare the effects of dual-task training with two different task priority instruction in people with Parkinson's disease and healthy controls on dual-task weight shifting performances.
- Investigate the changes of brain activities and functional connectivity after dual-task training with different task priority instructions.
[year 2-3]
To investigate the learning effects of walking with internal/external focus on walking automaticity and brain plasticity in dual-task walking training for PD patients with/without freezing of gait.
Read the detailed description
Postural-suprapostural task is defined as postural control takes place while another concurrent task is being performed, belonging to dual-task paradigms. Effective dual-task training is important to patients with Parkinson disease (PD), because they often lose balance and fall in dual-task conditions. Attentional strategy includes 1) task-priority between postural and suprapostural tasks and 2) internal and external focus for the postural task, which is the critical factor for both dual-task control and motor learning. However, the appropriateness of attentional strategy has not been investigated in dual-task training in patients with PD. Besides, there is lack of neural evidence of brain plasticity for previous studies about dual-task training in patients with PD. With the uses of EEG, EMG and behavioral measures, the purpose of this 3-year research project is to investigate the differences in performance quality and intrinsic neural mechanisms of dual-task training in PD, by adopting task-priority strategy and internal/external strategy during weight-shifting and walking. In the first year, the investigators will characterize task-priority effect (posture-priority vs. supraposture-priority) on dual-task training, with a special focus on modulation of brain plasticity and muscle activity patterns in weight-shifting posture for patients with PD. In the second and third years, the learning effects of walking internal/external focus on walking automaticity and brain plasticity will be investigated in dual-task walking training for PD patients with/without freezing of gait. Besides, the transfer effects of dual-task learning will be also investigated on medication "off" state. The present project is expected to have significant contributions not only to gain a better insight to neural correlates of dual-task training with different attentional strategies under weight-shifting and walking, but to optimize treatment strategy for PD patients with balance or dual-tasking disturbances.
- Conditions
- Parkinson Disease
- Being tested
- [year1] dual-task training with task priority strategy, [year2-3] dual-task training with internal and external focus
- Keywords
- dual-task training, attention, Parkinson's disease, walking, EEG
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[year1] dual-task training with task priority strategyBehavioural
postural focus: focus mainly on postural performances while dual-tasking suprapostural focus: focus mainly on suprapostural performances while dual-tasking
[year2-3] dual-task training with internal and external focusBehavioural
internal focus: focus mainly on body movements external focus: focus mainly on object in the environment
| Study group | Role | What they receive |
|---|---|---|
| [year1] PD group | Experimental | Not described Receives: Behavioral: [year1] dual-task training with task priority strategy |
| [year1] healthy control group | Active comparator | Not described Receives: Behavioral: [year1] dual-task training with task priority strategy |
| [year2-3] freezer | Experimental | Not described Receives: Behavioral: [year2-3] dual-task training with internal and external focus |
| [year2-3] non-freezer | Experimental | Not described Receives: Behavioral: [year2-3] dual-task training with internal and external focus |
What is being measured
The primary outcome is the main question the study is designed to answer.
postural performance
measuring the amount of body weight shifting (unit: kg)
Measured: about 36 seconds for each trial for a total of 25 minutes
suprapostural performance
measuring the rotation angle of box on the hand (unit: degree)
Measured: about 36 seconds for each trial for a total of 25 minutes
Walking speed
collecting by using the GAITRite electronic walkway (CIR systems, Inc. ,USA) 24 inches(61cm) wide and 192 inches (488cm, 16ft) long, total 18,432 sensor (unit: m/s)
Measured: about 10-20 seconds for each trial
Cadence
collecting by using the GAITRite (unit: step/s)
Measured: about 10-20 seconds for each trial
Gait symmetry
collecting single leg supporting time of right and left leg by using the GAITRite
Measured: about 10-20 seconds for each trial
Secondary outcomes (2)
electroencephalography (EEG)
to collect the brain activity (unit: uV)
Measured: about 36 seconds for each trial for a total of 25 minutes
electromyography (EMG)
to collect the muscle activity (unit: mV)
Measured: about 36 seconds for each trial for a total of 25 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start7 Mar 2019
- Primary completion12 Feb 2020
- Study completion12 Feb 2020
Why it stopped: Study halted prematurely and will not resume
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 1 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, School & Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895125
- Sponsor's protocol ID
- 201812110RINC
- Status last verified
- Mar 2019
- First submitted
- 13 Mar 2019
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Learning Effects of Attentional Strategy on Dual-task Walking in Patients With Parkinson's Disease: Behavioral Performance and Neural Plasticity
- ClinicalTrials.gov ID
- NCT03895125
- Acronym / sponsor ID
- 201812110RINC
- Conditions
- Parkinson Disease
- Keywords
- dual-task training, attention, Parkinson's disease, walking, EEG
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study halted prematurely and will not resume
- Enrolment
- 1 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 7 Mar 2019 (actual)
- Primary completion
- 12 Feb 2020 (actual)
- Study completion
- 12 Feb 2020 (actual)
- First posted
- 29 Mar 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.
[year1]
- To compare the effects of dual-task training with two different task priority instruction in people with Parkinson's disease and healthy controls on dual-task weight shifting performances.
- Investigate the changes of brain activities and functional connectivity after dual-task training with different task priority instructions.
[year 2-3]
To investigate the learning effects of walking with internal/external focus on walking automaticity and brain plasticity in dual-task walking training for PD patients with/without freezing of gait.
Detailed description
Postural-suprapostural task is defined as postural control takes place while another concurrent task is being performed, belonging to dual-task paradigms. Effective dual-task training is important to patients with Parkinson disease (PD), because they often lose balance and fall in dual-task conditions. Attentional strategy includes 1) task-priority between postural and suprapostural tasks and 2) internal and external focus for the postural task, which is the critical factor for both dual-task control and motor learning. However, the appropriateness of attentional strategy has not been investigated in dual-task training in patients with PD. Besides, there is lack of neural evidence of brain plasticity for previous studies about dual-task training in patients with PD. With the uses of EEG, EMG and behavioral measures, the purpose of this 3-year research project is to investigate the differences in performance quality and intrinsic neural mechanisms of dual-task training in PD, by adopting task-priority strategy and internal/external strategy during weight-shifting and walking. In the first year, the investigators will characterize task-priority effect (posture-priority vs. supraposture-priority) on dual-task training, with a special focus on modulation of brain plasticity and muscle activity patterns in weight-shifting posture for patients with PD. In the second and third years, the learning effects of walking internal/external focus on walking automaticity and brain plasticity will be investigated in dual-task walking training for PD patients with/without freezing of gait. Besides, the transfer effects of dual-task learning will be also investigated on medication "off" state. The present project is expected to have significant contributions not only to gain a better insight to neural correlates of dual-task training with different attentional strategies under weight-shifting and walking, but to optimize treatment strategy for PD patients with balance or dual-tasking disturbances.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| [year1] PD group | Experimental | Behavioral: [year1] dual-task training with task priority strategy |
| [year1] healthy control group | Active comparator | Behavioral: [year1] dual-task training with task priority strategy |
| [year2-3] freezer | Experimental | Behavioral: [year2-3] dual-task training with internal and external focus |
| [year2-3] non-freezer | Experimental | Behavioral: [year2-3] dual-task training with internal and external focus |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- For people with Parkinson's disease
- For healthy controls
- age and gender matched healthy subjects as control group
Key exclusion criteria (9 listed)
- MMSE < 26
- with other disease that may influence balance ability
- with marked action and postural tremor
- idiopathic Parkinson's disease
- modified Hoehn \& Yahr stage 2-3
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 |
|---|---|---|
| [year1] dual-task training with task priority strategypostural focus: focus mainly on postural performances while dual-tasking suprapostural focus: focus mainly on suprapostural performances while dual-tasking | Behavioural | [year1] PD group, [year1] healthy control group |
| [year2-3] dual-task training with internal and external focusinternal focus: focus mainly on body movements external focus: focus mainly on object in the environment | Behavioural | [year2-3] freezer, [year2-3] non-freezer |
Primary outcome
postural performance
Time frame: about 36 seconds for each trial for a total of 25 minutes
measuring the amount of body weight shifting (unit: kg)
suprapostural performance
Time frame: about 36 seconds for each trial for a total of 25 minutes
measuring the rotation angle of box on the hand (unit: degree)
Walking speed
Time frame: about 10-20 seconds for each trial
collecting by using the GAITRite electronic walkway (CIR systems, Inc. ,USA) 24 inches(61cm) wide and 192 inches (488cm, 16ft) long, total 18,432 sensor (unit: m/s)
Cadence
Time frame: about 10-20 seconds for each trial
collecting by using the GAITRite (unit: step/s)
Gait symmetry
Time frame: about 10-20 seconds for each trial
collecting single leg supporting time of right and left leg by using the GAITRite
2 secondary outcomes
electroencephalography (EEG)
Time frame: about 36 seconds for each trial for a total of 25 minutes
electromyography (EMG)
Time frame: about 36 seconds for each trial for a total of 25 minutes
Results and safety
The study was stopped early (reason given: Study halted prematurely and will not resume). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
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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
School & Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [year1] dual-task training with task priority strategy and [year2-3] dual-task training with internal and external focus in people with Parkinson Disease, run by National Taiwan 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 9 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: stopped early, as of the sponsor's last update on 13 Feb 2020. 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 was stopped early (reason given: Study halted prematurely and will not resume). Results are not available in the source record.
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?
postural performance (time frame: about 36 seconds for each trial for a total of 25 minutes). The study lists 5 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 13 Feb 2020.