Parkinson Disease Clinical Trial
Official title:
Investigation of the Psychometric Properties of the Squares Test in Measuring Hand Function in Parkinson's Disease
| 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 |
| Verified date | June 2018 |
| Source | Gazi University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Gazi University |
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
| 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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