Investigation of the Psychometric Properties of the Squares Test in Measuring Hand Function in Parkinson's Disease

July 6, 2018 updated by: Fatih Söke, Gazi University

The first aim of the present study was to investigate reliability, validity and responsiveness to the minimal clinically important difference, which is defined as the smallest change in score corresponding to clinically meaningful change realized by patient, of the squares test in people with PD.

The second aim of the study is to determine the relationship between hand function and both trunk control and balance in PD population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

At baseline, the ST, Unified Parkinson's Disease Rating Scale (UPDRS), Hoehn and Yahr (H&Y) Scale, Berg Balance Scale (BBS) and Trunk Impairment Scale (TIS) was applied to the PS group when the patients were "on" period. The ST was repeated after seven days from the first application when PD group were "on" period to evaluate its reliability.

Study Type

Observational

Enrollment (Actual)

107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with Parkinson's Disease who apply to the Dokuz Eylül University Hospital will be invited to this study.

Description

Inclusion Criteria:

  • at least 40 years of age
  • neurologist-diagnosed idiopathic PD (using UK Brain Bank criteria)
  • Hoehn & Yahr (H&Y) stages 1 to 4
  • Mini-Mental State Examination ≥ 22/30 (literate and with 5 or more years of education) and ≥18/30 (illiterate and with less than 5 years of education)
  • living in the community

Exclusion Criteria:

  • individuals with other major diseases (e.g., cancer, stroke, epilepsy, dementia, and severe rheumatoid arthritis)
  • preexisting disabilities
  • visual impairments
  • diagnosis of atypical Parkinsonism
  • H&Y stage 5
  • previous surgical management of PD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with Parkinson's Disease
Parkinson's Disease (Hoehn and Yahr stage 1-4)
Other: The squares test
The squares test (ST) originally used in handedness is modified. The ST is a reliable, not time-consuming and easy to administer test for evaluated hand function.
Healthy controls
Healthy people
Other: The squares test
The squares test (ST) originally used in handedness is modified. The ST is a reliable, not time-consuming and easy to administer test for evaluated hand function.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Squares Test
Time Frame: 2 minutes
The Squares Test is used to evaluate hand function.
2 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Nine-Hole Peg Test
Time Frame: 2 minutes
The Nine-Hole Peg Test is used to evaluate hand function.
2 minutes
Berg Balance Scale
Time Frame: 15 minutes
Functional balance performance was assessed with the Berg Balance scale.
15 minutes
Trunk Impairment Scale
Time Frame: 20 minutes
Trunk control was assessed by the Trunk Impairment Scale.
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gazi University

Investigators

  • Principal Investigator: Fatih Söke, Gazi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2014

Primary Completion (Actual)

August 17, 2015

Study Completion (Actual)

August 17, 2015

Study Registration Dates

First Submitted

June 29, 2018

First Submitted That Met QC Criteria

July 6, 2018

First Posted (Actual)

July 9, 2018

Study Record Updates

Last Update Posted (Actual)

July 9, 2018

Last Update Submitted That Met QC Criteria

July 6, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 844

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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