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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04364152
Other study ID # 202001029RIND
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 6, 2020
Est. completion date August 1, 2023

Study information

Verified date August 2023
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date August 1, 2023
Est. primary completion date August 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Taiwan School and Graduate Institute of Physical Therapy, National Taiwan University Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gait velocity from GAITRite gait performance 60 minutes
Primary Cadence from GAITRite gait performance 60 minutes
Primary Mean step length from GAITRite gait performance 60 minutes
Primary Step-to-step variability from GAITRite gait performance 60 minutes
Primary Amplitude from a triaxial accelerometer, X axes motor suprapostural task performance 25 minutes
Primary Amplitude from a triaxial accelerometer, Y axes motor suprapostural task performance 25 minutes
Primary Amplitude from a triaxial accelerometer, Z axes motor suprapostural task performance 25 minutes
Primary Correct rate on working memory task cognitive suprapostural task performance 25 minutes
Secondary EEG relative power in the delta band brain activity under single, motor dual-task, and cognitive dual-task walking conditions 60 minutes
Secondary EEG relative power in the theta band brain activity under single, motor dual-task, and cognitive dual-task walking conditions 60 minutes
Secondary EEG relative power in the alpha band brain activity under single, motor dual-task, and cognitive dual-task walking conditions 60 minutes
Secondary EEG relative power in the beta band brain activity under single, motor dual-task, and cognitive dual-task walking conditions 60 minutes
Secondary EEG relative power in the low gamma band brain activity under single, motor dual-task, and cognitive dual-task walking conditions 60 minutes
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