NCT03895125

Brief Summary

\[year1\]

  1. 1.To compare the effects of dual-task training with two different task priority instruction in people with Parkinson's disease and healthy controls on dual-task weight shifting performances.
  2. 2.Investigate the changes of brain activities and functional connectivity after dual-task training with different task priority instructions.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2019

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 29, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2020

Completed
Last Updated

February 13, 2020

Status Verified

March 1, 2019

Enrollment Period

11 months

First QC Date

March 13, 2019

Last Update Submit

February 11, 2020

Conditions

Parkinson Disease

Keywords

dual-task trainingattentionParkinson's diseasewalkingEEG

Outcome Measures

Primary Outcomes (5)

  • postural performance

    measuring the amount of body weight shifting (unit: kg)

    about 36 seconds for each trial for a total of 25 minutes

  • suprapostural performance

    measuring the rotation angle of box on the hand (unit: degree)

    about 36 seconds for each trial for a total of 25 minutes

  • Walking speed

    collecting by using the GAITRite electronic walkway (CIR systems, Inc. ,USA) 24 inches(61cm) wide and 192 inches (488cm, 16ft) long, total 18,432 sensor (unit: m/s)

    about 10-20 seconds for each trial

  • Cadence

    collecting by using the GAITRite (unit: step/s)

    about 10-20 seconds for each trial

  • Gait symmetry

    collecting single leg supporting time of right and left leg by using the GAITRite

    about 10-20 seconds for each trial

Secondary Outcomes (2)

  • electroencephalography (EEG)

    about 36 seconds for each trial for a total of 25 minutes

  • electromyography (EMG)

    about 36 seconds for each trial for a total of 25 minutes

Study Arms (4)

[year1] PD group

EXPERIMENTAL
Behavioral: [year1] dual-task training with task priority strategy

[year1] healthy control group

ACTIVE COMPARATOR
Behavioral: [year1] dual-task training with task priority strategy

[year2-3] freezer

EXPERIMENTAL
Behavioral: [year2-3] dual-task training with internal and external focus

[year2-3] non-freezer

EXPERIMENTAL
Behavioral: [year2-3] dual-task training with internal and external focus

Interventions

[year1] dual-task training with task priority strategyBEHAVIORAL

postural focus: focus mainly on postural performances while dual-tasking suprapostural focus: focus mainly on suprapostural performances while dual-tasking

[year1] PD group[year1] healthy control group
[year2-3] dual-task training with internal and external focusBEHAVIORAL

internal focus: focus mainly on body movements external focus: focus mainly on object in the environment

[year2-3] freezer[year2-3] non-freezer

Eligibility Criteria

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

You may qualify if:

  • For people with Parkinson's disease
  • modified Hoehn \& Yahr stage 2-3
  • without dementia and able to follow instructions
  • For healthy controls
  • age and gender matched healthy subjects as control group

You may not qualify if:

  • MMSE \< 26
  • with other disease that may influence balance ability
  • with marked action and postural tremor
  • idiopathic Parkinson's disease
  • modified Hoehn \& Yahr stage 2-3
  • without marked action or postural tremor
  • MMSE \< 26
  • with other disease that may influence balance ability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 10048, Taiwan

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Cheng-Ya Huang

    School & Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2019

First Posted

March 29, 2019

Study Start

March 7, 2019

Primary Completion

February 12, 2020

Study Completion

February 12, 2020

Last Updated

February 13, 2020

Record last verified: 2019-03

Locations

TW(1)