- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04364152
Effects of Attentional Focus Strategy on Dual-task Walking Training in Patients With Parkinson's Disease
September 5, 2023 updated by: National Taiwan University Hospital
Effects of Attentional Focus Strategy on Dual-task Walking Training in Parkinson's Disease With and Without Freezing of Gait
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
50
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
-
-
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Taipei, Taiwan, 100
- School and Graduate Institute of Physical Therapy, National Taiwan University
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-
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
Description
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.
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PD patients with freezing of gait, internal strategies
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 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.
|
|
Experimental: PD patients with freezing of gait, external strategies
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 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.
|
|
Experimental: PD patients without freezing of gait, internal strategies
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 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.
|
|
Experimental: PD patients without freezing of gait, external strategies
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 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.
|
|
Experimental: Healthy elders, internal strategies
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 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.
|
|
Experimental: Healthy elders, external strategies
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 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gait velocity from GAITRite
Time Frame: 60 minutes
|
gait performance
|
60 minutes
|
|
Cadence from GAITRite
Time Frame: 60 minutes
|
gait performance
|
60 minutes
|
|
Mean step length from GAITRite
Time Frame: 60 minutes
|
gait performance
|
60 minutes
|
|
Step-to-step variability from GAITRite
Time Frame: 60 minutes
|
gait performance
|
60 minutes
|
|
Amplitude from a triaxial accelerometer, X axes
Time Frame: 25 minutes
|
motor suprapostural task performance
|
25 minutes
|
|
Amplitude from a triaxial accelerometer, Y axes
Time Frame: 25 minutes
|
motor suprapostural task performance
|
25 minutes
|
|
Amplitude from a triaxial accelerometer, Z axes
Time Frame: 25 minutes
|
motor suprapostural task performance
|
25 minutes
|
|
Correct rate on working memory task
Time Frame: 25 minutes
|
cognitive suprapostural task performance
|
25 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
EEG relative power in the delta band
Time Frame: 60 minutes
|
brain activity under single, motor dual-task, and cognitive dual-task walking conditions
|
60 minutes
|
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EEG relative power in the theta band
Time Frame: 60 minutes
|
brain activity under single, motor dual-task, and cognitive dual-task walking conditions
|
60 minutes
|
|
EEG relative power in the alpha band
Time Frame: 60 minutes
|
brain activity under single, motor dual-task, and cognitive dual-task walking conditions
|
60 minutes
|
|
EEG relative power in the beta band
Time Frame: 60 minutes
|
brain activity under single, motor dual-task, and cognitive dual-task walking conditions
|
60 minutes
|
|
EEG relative power in the low gamma band
Time Frame: 60 minutes
|
brain activity under single, motor dual-task, and cognitive dual-task walking conditions
|
60 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
August 6, 2020
Primary Completion (Actual)
August 1, 2021
Study Completion (Actual)
August 1, 2023
Study Registration Dates
First Submitted
April 23, 2020
First Submitted That Met QC Criteria
April 23, 2020
First Posted (Actual)
April 27, 2020
Study Record Updates
Last Update Posted (Actual)
September 7, 2023
Last Update Submitted That Met QC Criteria
September 5, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202001029RIND
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
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