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Effects of Attentional Focus Strategy on Dual-task Walking Training in Patients With Parkinson's Disease

Primary Purpose

Parkinson Disease, Dual-task Walking

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Dual-task walking training
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson, dual-task training, attention, electroencephalogram (EEG)

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

for PD patients:

  • (1) a diagnosis of idiopathic PD by a neurologist expert in movement disorders (2) onset age > 40 years old, (3) presence of gait disorders or freezing of gait (points on 3.10 in MDS-UPDRS>=1 or points on item 3 in NFOG-Q >0) (4) able to walk independently without an assistance device at least for 20 meters (5) without obvious action or postural tremor, according to the score of 3.15 and 3.16 (action and postural tremor of hands) in MDS-UPDRS

for healthy elders:

  • (1) without musculoskeletal of neurological diseases which may affect balance or walking performance (2) no medication that might influence their balance or cognition (3) MMSE> 26 points.

Exclusion Criteria:

for PD patients:

  • (1) with other neurological or musculoskeletal disease that might affect balance or walking (2) have a Mini-Mental State Examination (MMSE) < 27 points (3) have a history of brain surgery (4) have to modulate their medication for duration of the experiment.

Sites / Locations

  • School and Graduate Institute of Physical Therapy, National Taiwan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

PD patients with freezing of gait, internal strategies

PD patients with freezing of gait, external strategies

PD patients without freezing of gait, internal strategies

PD patients without freezing of gait, external strategies

Healthy elders, internal strategies

Healthy elders, external strategies

Arm Description

Participants in this group will include PD patients with freezing of gait. During dual-task walking training, internal attentional strategies will be given, aiming to improve their gait performance.

Participants in this group will include PD patients with freezing of gait. During dual-task walking training, external attentional strategies will be given, aiming to improve their gait performance.

Participants in this group will include PD patients without freezing of gait. During dual-task walking training, internal attentional strategies will be given, aiming to improve their gait performance.

Participants in this group will include PD patients without freezing of gait. During dual-task walking training, external attentional strategies will be given, aiming to improve their gait performance.

Participants in this group will include healthy elders. During dual-task walking training, internal attentional strategies will be given, aiming to improve their gait performance.

Participants in this group will include healthy elders. During dual-task walking training, internal attentional strategies will be given, aiming to improve their gait performance.

Outcomes

Primary Outcome Measures

Gait velocity from GAITRite
gait performance
Cadence from GAITRite
gait performance
Mean step length from GAITRite
gait performance
Step-to-step variability from GAITRite
gait performance
Amplitude from a triaxial accelerometer, X axes
motor suprapostural task performance
Amplitude from a triaxial accelerometer, Y axes
motor suprapostural task performance
Amplitude from a triaxial accelerometer, Z axes
motor suprapostural task performance
Correct rate on working memory task
cognitive suprapostural task performance

Secondary Outcome Measures

EEG relative power in the delta band
brain activity under single, motor dual-task, and cognitive dual-task walking conditions
EEG relative power in the theta band
brain activity under single, motor dual-task, and cognitive dual-task walking conditions
EEG relative power in the alpha band
brain activity under single, motor dual-task, and cognitive dual-task walking conditions
EEG relative power in the beta band
brain activity under single, motor dual-task, and cognitive dual-task walking conditions
EEG relative power in the low gamma band
brain activity under single, motor dual-task, and cognitive dual-task walking conditions

Full Information

First Posted
April 23, 2020
Last Updated
September 5, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04364152
Brief Title
Effects of Attentional Focus Strategy on Dual-task Walking Training in Patients With Parkinson's Disease
Official Title
Effects of Attentional Focus Strategy on Dual-task Walking Training in Parkinson's Disease With and Without Freezing of Gait
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 6, 2020 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
August 1, 2023 (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

5. Study Description

Brief Summary
Walking deficits and altered brain capacity have been proved to be two of the main contributing factors in dual-task walking deficits in patients with Parkinson's disease (PD). In the past, patients with PD were usually suggested not to walk in dual-task conditions in order to concentrate on their walking performance better. However, since dual-task walking is really common in daily-life, this limitation usually lead to a decrease in quality of life for PD patients. In previous studies, effects of using attentional strategies in dual-task walking training remain unclear, while suitable attentional strategies and corresponded neuroplasticity for patients with and without freezing of gait have not been well discussed, either. Accordingly, this study is aimed to identify (1) whether internal or external attentional strategies is more ideal for PD patients with and without freezing of gait in dual-task walking training, and (2) changes in brain activity after receiving dual-task walking training with different attentional strategies in patients with or without freezing of gait. Our hypothesis are (1) patients with or without freezing of gait will react differently in dual-gait training with different attentional strategies, and (2) changes in brain activities will be different according to different attentional strategies given in the training.
Detailed Description
The hypothesis will be tested by gait performance, suprapostural tasks performance, relative power spectrum of EEG, and scales including MDS-UPDRS, ABC, BBS, and TUG.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Dual-task Walking
Keywords
Parkinson, dual-task training, attention, electroencephalogram (EEG)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PD patients with freezing of gait, internal strategies
Arm Type
Experimental
Arm Description
Participants in this group will include PD patients with freezing of gait. During dual-task walking training, internal attentional strategies will be given, aiming to improve their gait performance.
Arm Title
PD patients with freezing of gait, external strategies
Arm Type
Experimental
Arm Description
Participants in this group will include PD patients with freezing of gait. During dual-task walking training, external attentional strategies will be given, aiming to improve their gait performance.
Arm Title
PD patients without freezing of gait, internal strategies
Arm Type
Experimental
Arm Description
Participants in this group will include PD patients without freezing of gait. During dual-task walking training, internal attentional strategies will be given, aiming to improve their gait performance.
Arm Title
PD patients without freezing of gait, external strategies
Arm Type
Experimental
Arm Description
Participants in this group will include PD patients without freezing of gait. During dual-task walking training, external attentional strategies will be given, aiming to improve their gait performance.
Arm Title
Healthy elders, internal strategies
Arm Type
Experimental
Arm Description
Participants in this group will include healthy elders. During dual-task walking training, internal attentional strategies will be given, aiming to improve their gait performance.
Arm Title
Healthy elders, external strategies
Arm Type
Experimental
Arm Description
Participants in this group will include healthy elders. During dual-task walking training, internal attentional strategies will be given, aiming to improve their gait performance.
Intervention Type
Behavioral
Intervention Name(s)
Dual-task walking training
Intervention Description
Participants will be instructed to perform both motor and cognitive dual-task walking during exercise training. For example, for motor dual-task walking, the participants may be instructed to throw and catch a ball while walking. As for cognitive dual-task walking, the participants may be instructed to name animals or perform calculation while walking.
Primary Outcome Measure Information:
Title
Gait velocity from GAITRite
Description
gait performance
Time Frame
60 minutes
Title
Cadence from GAITRite
Description
gait performance
Time Frame
60 minutes
Title
Mean step length from GAITRite
Description
gait performance
Time Frame
60 minutes
Title
Step-to-step variability from GAITRite
Description
gait performance
Time Frame
60 minutes
Title
Amplitude from a triaxial accelerometer, X axes
Description
motor suprapostural task performance
Time Frame
25 minutes
Title
Amplitude from a triaxial accelerometer, Y axes
Description
motor suprapostural task performance
Time Frame
25 minutes
Title
Amplitude from a triaxial accelerometer, Z axes
Description
motor suprapostural task performance
Time Frame
25 minutes
Title
Correct rate on working memory task
Description
cognitive suprapostural task performance
Time Frame
25 minutes
Secondary Outcome Measure Information:
Title
EEG relative power in the delta band
Description
brain activity under single, motor dual-task, and cognitive dual-task walking conditions
Time Frame
60 minutes
Title
EEG relative power in the theta band
Description
brain activity under single, motor dual-task, and cognitive dual-task walking conditions
Time Frame
60 minutes
Title
EEG relative power in the alpha band
Description
brain activity under single, motor dual-task, and cognitive dual-task walking conditions
Time Frame
60 minutes
Title
EEG relative power in the beta band
Description
brain activity under single, motor dual-task, and cognitive dual-task walking conditions
Time Frame
60 minutes
Title
EEG relative power in the low gamma band
Description
brain activity under single, motor dual-task, and cognitive dual-task walking conditions
Time Frame
60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: for PD patients: (1) a diagnosis of idiopathic PD by a neurologist expert in movement disorders (2) onset age > 40 years old, (3) presence of gait disorders or freezing of gait (points on 3.10 in MDS-UPDRS>=1 or points on item 3 in NFOG-Q >0) (4) able to walk independently without an assistance device at least for 20 meters (5) without obvious action or postural tremor, according to the score of 3.15 and 3.16 (action and postural tremor of hands) in MDS-UPDRS for healthy elders: (1) without musculoskeletal of neurological diseases which may affect balance or walking performance (2) no medication that might influence their balance or cognition (3) MMSE> 26 points. Exclusion Criteria: for PD patients: (1) with other neurological or musculoskeletal disease that might affect balance or walking (2) have a Mini-Mental State Examination (MMSE) < 27 points (3) have a history of brain surgery (4) have to modulate their medication for duration of the experiment.
Facility Information:
Facility Name
School and Graduate Institute of Physical Therapy, National Taiwan University
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Attentional Focus Strategy on Dual-task Walking Training in Patients With Parkinson's Disease

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