NCT04494906

Brief Summary

The objective of this study is to investigate the effects of interactive stepping exercise on balance and cognitive function in individuals with PD.

Trial Health

43
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 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 28, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

August 19, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

August 27, 2020

Status Verified

August 1, 2020

Enrollment Period

1.4 years

First QC Date

July 28, 2020

Last Update Submit

August 25, 2020

Conditions

Parkinson's Disease

Keywords

Interactive stepping exerciseSquare stepping exerciseParkinson's diseaseBalance abilityCognitive function

Outcome Measures

Primary Outcomes (10)

  • Romberg test

    To evaluate static balance ability

    Change from baseline at 8 weeks and 12 weeks

  • Sharpened Romberg test

    To evaluate static balance ability

    Change from baseline at 8 weeks and 12 weeks

  • One-leg stance test

    To evaluate static balance ability

    Change from baseline at 8 weeks and 12 weeks

  • Timed up and go test

    To evaluate functional walking ability

    Change from baseline at 8 weeks and 12 weeks

  • Mini-Balance Evaluation Systems Test

    To evaluate balance ability

    Change from baseline at 8 weeks and 12 weeks

  • Montreal Cognitive Assessment Chinese version

    To evaluate global cognitive function

    Change from baseline at 8 weeks and 12 weeks

  • Digit span test

    To evaluate executive function

    Change from baseline at 8 weeks and 12 weeks

  • Stroop color and word test Chinese version

    To evaluate executive function

    Change from baseline at 8 weeks and 12 weeks

  • Trail-making test Chinese version

    To evaluate executive function

    Change from baseline at 8 weeks and 12 weeks

  • Spatial span test

    To evaluate visuospatial ability

    Change from baseline at 8 weeks and 12 weeks

Secondary Outcomes (2)

  • 10-meter walk test

    Change from baseline at 8 weeks and 12 weeks

  • Parkinson's Disease Questionnaire 39

    Change from baseline at 8 weeks and 12 weeks

Study Arms (2)

Interactive stepping exercise group

EXPERIMENTAL

Participants will execute interactive stepping exercise 2 times per week for 8 weeks (16 sessions).

Other: Interactive stepping exercise

Square stepping exercise group

ACTIVE COMPARATOR

Participants will execute square stepping exercise 2 times per week for 8 weeks (16 sessions).

Other: Square stepping exercise

Interventions

Interactive stepping exerciseOTHER

An exercise intervention based on the principle of square stepping exercise

Interactive stepping exercise group
Square stepping exerciseOTHER

Square stepping exercise

Square stepping exercise group

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Idiopathic PD
  • Hoehn \& Yahr stage between 1 to 3
  • Age between 50 to 85
  • Stable pharmacologic treatment for the last 2 weeks
  • Ability to walk 10 meters unassisted or with assistive devices

You may not qualify if:

  • Other neurological disorders diagnosis than PD
  • Receiving any neurological surgeries
  • Any musculoskeletal disorder or cardiopulmonary disease that may influence participation in the study
  • The Mini-Mental State Examination (MMSE) \< 24 scores
  • Participated in other exercise intervention of study in the past 3 months
  • Colorblindness or color vision deficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Yang-Ming University

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Yea-Ru Yang, PhD

CONTACT

+886-2-28267279yryang@ym.edu.tw

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 28, 2020

First Posted

July 31, 2020

Study Start

August 19, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

August 27, 2020

Record last verified: 2020-08

Locations

TW(1)