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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • School and Graduate Institute of Physical Therapy, National Taiwan University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Dual-task walking training
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.
Behavioral: Dual-task walking training
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.
Behavioral: Dual-task walking training
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.
Behavioral: Dual-task walking training
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.
Behavioral: Dual-task walking training
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.
Behavioral: Dual-task walking training
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 6, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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