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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03580486
Other study ID # 844
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 19, 2014
Est. completion date August 17, 2015

Study information

Verified date June 2018
Source Gazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 107
Est. completion date August 17, 2015
Est. primary completion date August 17, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

References & Publications (9)

Annett M. Five tests of hand skill. Cortex. 1992 Dec;28(4):583-600. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The Squares Test The Squares Test is used to evaluate hand function. 2 minutes
Secondary The Nine-Hole Peg Test The Nine-Hole Peg Test is used to evaluate hand function. 2 minutes
Secondary Berg Balance Scale Functional balance performance was assessed with the Berg Balance scale. 15 minutes
Secondary Trunk Impairment Scale Trunk control was assessed by the Trunk Impairment Scale. 20 minutes
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