NCT03580486

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2014

Shorter than P25 for all trials

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

December 19, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2015

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 9, 2018

Completed
Last Updated

July 9, 2018

Status Verified

June 1, 2018

Enrollment Period

8 months

First QC Date

June 29, 2018

Last Update Submit

July 6, 2018

Conditions

Keywords

Parkinson's DiseaseHand FunctionSquares Test

Outcome Measures

Primary Outcomes (1)

  • The Squares Test

    The Squares Test is used to evaluate hand function.

    2 minutes

Secondary Outcomes (3)

  • The Nine-Hole Peg Test

    2 minutes

  • Berg Balance Scale

    15 minutes

  • Trunk Impairment Scale

    20 minutes

Study Arms (2)

Patients with Parkinson's Disease

Parkinson's Disease (Hoehn and Yahr stage 1-4)

Other: The squares test

Healthy controls

Healthy people

Other: The squares test

Interventions

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 controlsPatients with Parkinson's Disease

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 Dokuz Eylül University Hospital will be invited to this study.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • Annett M. Five tests of hand skill. Cortex. 1992 Dec;28(4):583-600. doi: 10.1016/s0010-9452(13)80229-8.

    PMID: 1478086BACKGROUND
  • Verheyden G, Willems AM, Ooms L, Nieuwboer A. Validity of the trunk impairment scale as a measure of trunk performance in people with Parkinson's disease. Arch Phys Med Rehabil. 2007 Oct;88(10):1304-8. doi: 10.1016/j.apmr.2007.06.772.

    PMID: 17908573BACKGROUND
  • Leddy AL, Crowner BE, Earhart GM. Functional gait assessment and balance evaluation system test: reliability, validity, sensitivity, and specificity for identifying individuals with Parkinson disease who fall. Phys Ther. 2011 Jan;91(1):102-13. doi: 10.2522/ptj.20100113. Epub 2010 Nov 11.

    PMID: 21071506BACKGROUND
  • Earhart GM, Cavanaugh JT, Ellis T, Ford MP, Foreman KB, Dibble L. The 9-hole PEG test of upper extremity function: average values, test-retest reliability, and factors contributing to performance in people with Parkinson disease. J Neurol Phys Ther. 2011 Dec;35(4):157-63. doi: 10.1097/NPT.0b013e318235da08.

    PMID: 22020457BACKGROUND
  • Proud EL, Miller KJ, Bilney B, Balachandran S, McGinley JL, Morris ME. Evaluation of measures of upper limb functioning and disability in people with Parkinson disease: a systematic review. Arch Phys Med Rehabil. 2015 Mar;96(3):540-551.e1. doi: 10.1016/j.apmr.2014.09.016. Epub 2014 Oct 7.

    PMID: 25301441BACKGROUND
  • Gebhardt A, Vanbellingen T, Baronti F, Kersten B, Bohlhalter S. Poor dopaminergic response of impaired dexterity in Parkinson's disease: Bradykinesia or limb kinetic apraxia? Mov Disord. 2008 Sep 15;23(12):1701-6. doi: 10.1002/mds.22199.

    PMID: 18649388BACKGROUND
  • Foki T, Vanbellingen T, Lungu C, Pirker W, Bohlhalter S, Nyffeler T, Kraemmer J, Haubenberger D, Fischmeister FP, Auff E, Hallett M, Beisteiner R. Limb-kinetic apraxia affects activities of daily living in Parkinson's disease: a multi-center study. Eur J Neurol. 2016 Aug;23(8):1301-7. doi: 10.1111/ene.13021. Epub 2016 May 1.

    PMID: 27132653BACKGROUND
  • Gillen G, Boiangiu C, Neuman M, Reinstein R, Schaap Y. Trunk posture affects upper extremity function of adults. Percept Mot Skills. 2007 Apr;104(2):371-80. doi: 10.2466/pms.104.2.371-380.

    PMID: 17566426BACKGROUND
  • Schenkman M, Morey M, Kuchibhatla M. Spinal flexibility and balance control among community-dwelling adults with and without Parkinson's disease. J Gerontol A Biol Sci Med Sci. 2000 Aug;55(8):M441-5. doi: 10.1093/gerona/55.8.m441.

    PMID: 10952366BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Fatih Söke

    Gazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

June 29, 2018

First Posted

July 9, 2018

Study Start

December 19, 2014

Primary Completion

August 17, 2015

Study Completion

August 17, 2015

Last Updated

July 9, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share