NCT04267341

Brief Summary

The aim of the study is to investigate the change of lower and upper extremity skills with dual task in Parkinson's disease patients and to determine the differences between Parkinson's disease patients with different stages of disease and the healthy controls regarding the change of lower and upper extremity skills with dual task.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 11, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

December 3, 2020

Status Verified

December 1, 2020

Enrollment Period

2 months

First QC Date

February 11, 2020

Last Update Submit

December 1, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • Timed Up and Go Test

    Functional mobility is assessed by using the timed up and go test. The timed up and go test measures the time that a patient needs to stand up from a chair, walk a 3-m distance, come back and sit back on the chair.

    10-15 seconds

  • 10 Meter Walk Test

    10 Meter Walk Test measures the time required to complete straight walk of 10 meters distance.

    10-15 seconds

  • Purdue Pegboard Test

    Purdue Pegboard Test assesses the speed and motor dexterity of each hand and the manual dexterity using both hands at the same time. The PPT consists of a board with two columns with 25 holes each and a specific number of pins, washers and collars placed in four containers across the top of the board.

    3-5 minutes

Secondary Outcomes (3)

  • Modified Hoehn and Yahr Scale

    1 minute

  • Montreal Cognitive Assessment (MoCA)

    10-15 minutes

  • Short-Form 8-Item Parkinson's Disease Questionnaire (PDQ-8)

    1-2 minutes

Study Arms (3)

Mild Stage Parkinson's Disease Patients

Modified Hoehn and Yahr stage 1-2

Other: Timed Up and Go TestOther: 10 Meter Walk TestOther: Purdue Pegboard Test

Moderate Stage Parkinson's Disease Patients

Modified Hoehn and Yahr stage 2.5-3

Other: Timed Up and Go TestOther: 10 Meter Walk TestOther: Purdue Pegboard Test

Healthy Control

Healthy People

Other: Timed Up and Go TestOther: 10 Meter Walk TestOther: Purdue Pegboard Test

Interventions

It requires individual to stand up from an armed chair, walk 3m, turn around, walk back to the armed chair, and sit down again

Healthy ControlMild Stage Parkinson's Disease PatientsModerate Stage Parkinson's Disease Patients

10 Meter Walk Test measures the time required to complete straight walk of 10 meters distance

Healthy ControlMild Stage Parkinson's Disease PatientsModerate Stage Parkinson's Disease Patients

Purdue Pegboard test evaluates the fine manuel dexterity

Healthy ControlMild Stage Parkinson's Disease PatientsModerate Stage Parkinson's Disease Patients

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with Parkinson's Disease who apply to the Hacettepe University, Faculty of Physiotherapy and Rehabilitation, Department of Neurological Rehabilitation will be invited to this study.

You may qualify if:

  • Modified Hoehn \& Yahr (H\&Y) stages 1 to 3
  • at least 40 years of age
  • or more MoCA score.

You may not qualify if:

  • other neurologic disorder
  • any orthopedic problem that could prevent to participate in the study
  • severe dyskinesia or tremor
  • visual or speech problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson DiseaseMovement Disorders

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 11, 2020

First Posted

February 12, 2020

Study Start

January 1, 2020

Primary Completion

March 15, 2020

Study Completion

August 1, 2020

Last Updated

December 3, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations