NCT04364152

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 27, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

August 6, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

September 7, 2023

Status Verified

August 1, 2023

Enrollment Period

12 months

First QC Date

April 23, 2020

Last Update Submit

September 5, 2023

Conditions

Keywords

Parkinsondual-task trainingattentionelectroencephalogram (EEG)

Outcome Measures

Primary Outcomes (8)

  • Gait velocity from GAITRite

    gait performance

    60 minutes

  • Cadence from GAITRite

    gait performance

    60 minutes

  • Mean step length from GAITRite

    gait performance

    60 minutes

  • Step-to-step variability from GAITRite

    gait performance

    60 minutes

  • Amplitude from a triaxial accelerometer, X axes

    motor suprapostural task performance

    25 minutes

  • Amplitude from a triaxial accelerometer, Y axes

    motor suprapostural task performance

    25 minutes

  • Amplitude from a triaxial accelerometer, Z axes

    motor suprapostural task performance

    25 minutes

  • Correct rate on working memory task

    cognitive suprapostural task performance

    25 minutes

Secondary Outcomes (5)

  • EEG relative power in the delta band

    60 minutes

  • EEG relative power in the theta band

    60 minutes

  • EEG relative power in the alpha band

    60 minutes

  • EEG relative power in the beta band

    60 minutes

  • EEG relative power in the low gamma band

    60 minutes

Study Arms (6)

PD patients with freezing of gait, internal strategies

EXPERIMENTAL

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

PD patients with freezing of gait, external strategies

EXPERIMENTAL

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

PD patients without freezing of gait, internal strategies

EXPERIMENTAL

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

PD patients without freezing of gait, external strategies

EXPERIMENTAL

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

Healthy elders, internal strategies

EXPERIMENTAL

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

Healthy elders, external strategies

EXPERIMENTAL

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

Interventions

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.

Healthy elders, external strategiesHealthy elders, internal strategiesPD patients with freezing of gait, external strategiesPD patients with freezing of gait, internal strategiesPD patients without freezing of gait, external strategiesPD patients without freezing of gait, internal strategies

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School and Graduate Institute of Physical Therapy, National Taiwan University

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2020

First Posted

April 27, 2020

Study Start

August 6, 2020

Primary Completion

August 1, 2021

Study Completion

August 1, 2023

Last Updated

September 7, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations