The Learning Effects of Attentional Strategy on Dual-task Walking in Patients With Parkinson's Disease: Behavioral Performance and Neural Plasticity
Primary Purpose
Parkinson Disease
Status
Terminated
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
[year1] dual-task training with task priority strategy
[year2-3] dual-task training with internal and external focus
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring dual-task training, attention, Parkinson's disease, walking, EEG
Eligibility Criteria
[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
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Experimental
Arm Label
[year1] PD group
[year1] healthy control group
[year2-3] freezer
[year2-3] non-freezer
Arm Description
Outcomes
Primary Outcome Measures
postural performance
measuring the amount of body weight shifting (unit: kg)
suprapostural performance
measuring the rotation angle of box on the hand (unit: degree)
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)
Cadence
collecting by using the GAITRite (unit: step/s)
Gait symmetry
collecting single leg supporting time of right and left leg by using the GAITRite
Secondary Outcome Measures
electroencephalography (EEG)
to collect the brain activity (unit: uV)
electromyography (EMG)
to collect the muscle activity (unit: mV)
Full Information
NCT ID
NCT03895125
First Posted
March 13, 2019
Last Updated
February 11, 2020
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03895125
Brief Title
The Learning Effects of Attentional Strategy on Dual-task Walking in Patients With Parkinson's Disease: Behavioral Performance and Neural Plasticity
Official Title
The Learning Effects of Attentional Strategy on Dual-task Walking in Patients With Parkinson's Disease: Behavioral Performance and Neural Plasticity
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
Study halted prematurely and will not resume
Study Start Date
March 7, 2019 (Actual)
Primary Completion Date
February 12, 2020 (Actual)
Study Completion Date
February 12, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
[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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
dual-task training, attention, Parkinson's disease, walking, EEG
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
[year1] PD group
Arm Type
Experimental
Arm Title
[year1] healthy control group
Arm Type
Active Comparator
Arm Title
[year2-3] freezer
Arm Type
Experimental
Arm Title
[year2-3] non-freezer
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
[year1] dual-task training with task priority strategy
Intervention Description
postural focus: focus mainly on postural performances while dual-tasking suprapostural focus: focus mainly on suprapostural performances while dual-tasking
Intervention Type
Behavioral
Intervention Name(s)
[year2-3] dual-task training with internal and external focus
Intervention Description
internal focus: focus mainly on body movements external focus: focus mainly on object in the environment
Primary Outcome Measure Information:
Title
postural performance
Description
measuring the amount of body weight shifting (unit: kg)
Time Frame
about 36 seconds for each trial for a total of 25 minutes
Title
suprapostural performance
Description
measuring the rotation angle of box on the hand (unit: degree)
Time Frame
about 36 seconds for each trial for a total of 25 minutes
Title
Walking speed
Description
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)
Time Frame
about 10-20 seconds for each trial
Title
Cadence
Description
collecting by using the GAITRite (unit: step/s)
Time Frame
about 10-20 seconds for each trial
Title
Gait symmetry
Description
collecting single leg supporting time of right and left leg by using the GAITRite
Time Frame
about 10-20 seconds for each trial
Secondary Outcome Measure Information:
Title
electroencephalography (EEG)
Description
to collect the brain activity (unit: uV)
Time Frame
about 36 seconds for each trial for a total of 25 minutes
Title
electromyography (EMG)
Description
to collect the muscle activity (unit: mV)
Time Frame
about 36 seconds for each trial for a total of 25 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
[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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheng-Ya Huang
Organizational Affiliation
School & Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10048
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
The Learning Effects of Attentional Strategy on Dual-task Walking in Patients With Parkinson's Disease: Behavioral Performance and Neural Plasticity
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