- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03895125
The Learning Effects of Attentional Strategy on Dual-task Walking in Patients With Parkinson's Disease: Behavioral Performance and Neural Plasticity
February 11, 2020 updated by: National Taiwan University Hospital
[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.
Study Overview
Status
Terminated
Conditions
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 Type
Interventional
Enrollment (Actual)
1
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taipei, Taiwan, 10048
- National Taiwan University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
[year1]
Inclusion criteria:
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
Exclusion criteria:
- 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
- without marked action or postural tremor
exclusion criteria:
- MMSE < 26
- with other disease that may influence balance ability
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: [year1] PD group
|
postural focus: focus mainly on postural performances while dual-tasking suprapostural focus: focus mainly on suprapostural performances while dual-tasking
|
|
Active Comparator: [year1] healthy control group
|
postural focus: focus mainly on postural performances while dual-tasking suprapostural focus: focus mainly on suprapostural performances while dual-tasking
|
|
Experimental: [year2-3] freezer
|
internal focus: focus mainly on body movements external focus: focus mainly on object in the environment
|
|
Experimental: [year2-3] non-freezer
|
internal focus: focus mainly on body movements external focus: focus mainly on object in the environment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
about 36 seconds for each trial for a total of 25 minutes
|
|
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)
|
about 36 seconds for each trial for a total of 25 minutes
|
|
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)
|
about 10-20 seconds for each trial
|
|
Cadence
Time Frame: about 10-20 seconds for each trial
|
collecting by using the GAITRite (unit: step/s)
|
about 10-20 seconds for each trial
|
|
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
|
about 10-20 seconds for each trial
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
electroencephalography (EEG)
Time Frame: about 36 seconds for each trial for a total of 25 minutes
|
to collect the brain activity (unit: uV)
|
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
|
to collect the muscle activity (unit: mV)
|
about 36 seconds for each trial for a total of 25 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Cheng-Ya Huang, School & Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 7, 2019
Primary Completion (Actual)
February 12, 2020
Study Completion (Actual)
February 12, 2020
Study Registration Dates
First Submitted
March 13, 2019
First Submitted That Met QC Criteria
March 27, 2019
First Posted (Actual)
March 29, 2019
Study Record Updates
Last Update Posted (Actual)
February 13, 2020
Last Update Submitted That Met QC Criteria
February 11, 2020
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201812110RINC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.