NCT04033393

Brief Summary

This study aimed to investigate the effects of Game based dual-task training with treadmill on executive function and dual-task performance in individuals with early-onset PD and discuss the correlation between the change values of executive function and dual-task performance after training. Besides, investigate cortical activation after training.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable

Status
unknown

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

July 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

July 29, 2019

Status Verified

July 1, 2019

Enrollment Period

3 years

First QC Date

July 24, 2019

Last Update Submit

July 25, 2019

Conditions

Keywords

Executive functionDual-task performanceDual-task training

Outcome Measures

Primary Outcomes (1)

  • Dual-task walking performance

    To evaluate gait parameters while doing dual-task walking

    Change from baseline at 8 weeks

Secondary Outcomes (10)

  • Single walking performance

    Change from baseline at 8 weeks

  • Timed up and go test

    Change from baseline at 8 weeks

  • Parkinson's Disease Questionnaire 39

    Change from baseline at 8 weeks

  • Frontal lobe battery test-Chinese version

    Change from baseline at 8 weeks

  • Trail-making test

    Change from baseline at 8 weeks

  • +5 more secondary outcomes

Study Arms (2)

Game based dual-task training group

EXPERIMENTAL

Participants in dual-task training group will execute game based dual-task training with treadmill, 3 times per week for 8 weeks

Other: Game based dual-task training

Treadmill training group

ACTIVE COMPARATOR

Participants in treadmill training group will do treadmill training, 3 times per week for 8 weeks

Other: Treadmill training

Interventions

Participants in the experimental group will receive game based dual-task training with a treadmill

Game based dual-task training group

Participants in the control group will receive treadmill training

Treadmill training group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed as PD and Hoehn and Yahr stage between 1\~3
  • Age between 20 to 80
  • Able to walk 10 m independently without an assistive device
  • A score of greater than or equal to 24 on the mini-mental state examination (MMSE)
  • In stable medical condition allowing participation in the testing protocol and intervention

You may not qualify if:

  • Any comorbidity or disability other than PD that would preclude gait training
  • Any uncontrolled health condition for which exercise was contraindicated
  • Any neurological or orthopedic disease that might interfere with the study
  • Server freezing of gait, FOG questionnaire \> 15

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinsonian Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement Disorders

Central Study Contacts

Yang Yearu, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 24, 2019

First Posted

July 26, 2019

Study Start

August 1, 2019

Primary Completion

July 31, 2022

Study Completion

July 31, 2022

Last Updated

July 29, 2019

Record last verified: 2019-07