Parkinson DiseaseNCT03580486
Investigation of the Psychometric Properties of the Squares Test in Measuring Hand Function in Parkinson's Disease
An observational study of Parkinson Disease, run by Gazi University.
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- The squares test
- How many people
- 107 participants
- Where
- No sites listed yet
- Study dates
- 19 Dec 2014to 17 Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Parkinson's Disease who apply to the Dokuz Eylül University Hospital will be invited to this study.
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- The squares test
- Keywords
- Parkinson's Disease, Hand Function, Squares Test
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The squares testOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Parkinson's Disease | Parkinson's Disease (Hoehn and Yahr stage 1-4) Receives: Other: The squares test | |
| Healthy controls | Healthy people Receives: Other: The squares test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Squares Test
The Squares Test is used to evaluate hand function.
Measured: 2 minutes
Secondary outcomes (3)
The Nine-Hole Peg Test
The Nine-Hole Peg Test is used to evaluate hand function.
Measured: 2 minutes
Berg Balance Scale
Functional balance performance was assessed with the Berg Balance scale.
Measured: 15 minutes
Trunk Impairment Scale
Trunk control was assessed by the Trunk Impairment Scale.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2018
- Study start19 Dec 2014
- Primary completion17 Aug 2015
- Study completion17 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Söke, Gazi University
- Investigators
- Fatih Söke, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03580486
- Sponsor's protocol ID
- 844
- Status last verified
- Jun 2018
- First submitted
- 29 Jun 2018
- Last updated
- 9 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Annett M. Five tests of hand skill. Cortex. 1992 Dec;28(4):583-600. doi: 10.1016/s0010-9452(13)80229-8.
PubMed 1478086Verheyden 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.
PubMed 17908573Leddy 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.
PubMed 21071506Earhart 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.
PubMed 22020457Proud 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.
PubMed 25301441Gebhardt 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.
PubMed 18649388Foki 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.
PubMed 27132653Gillen 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.
PubMed 17566426Schenkman 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.
PubMed 10952366
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Psychometric Properties of the Squares Test in Measuring Hand Function in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03580486
- Acronym / sponsor ID
- 844
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's Disease, Hand Function, Squares Test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 19 Dec 2014 (actual)
- Primary completion
- 17 Aug 2015 (actual)
- Study completion
- 17 Aug 2015 (actual)
- First posted
- 9 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Parkinson's Disease | – | Other: The squares testParkinson's Disease (Hoehn and Yahr stage 1-4) |
| Healthy controls | – | Other: The squares testHealthy people |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Parkinson's Disease who apply to the Dokuz Eylül University Hospital will be invited to this study.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The squares testThe 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. | Other | Healthy controls, Patients with Parkinson's Disease |
Primary outcome
The Squares Test
Time frame: 2 minutes
The Squares Test is used to evaluate hand function.
3 secondary outcomes
The Nine-Hole Peg Test
Time frame: 2 minutes
Berg Balance Scale
Time frame: 15 minutes
Trunk Impairment Scale
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2018.
- Background: PubMed 1478086Annett M. Five tests of hand skill. Cortex. 1992 Dec;28(4):583-600. doi: 10.1016/s0010-9452(13)80229-8.
- Background: PubMed 17908573Verheyden 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.
- Background: PubMed 21071506Leddy 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.
- Background: PubMed 22020457Earhart 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.
- Background: PubMed 25301441Proud 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.
- Background: PubMed 18649388Gebhardt 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.
- Background: PubMed 27132653Foki 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.
- Background: PubMed 17566426Gillen 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.
- Background: PubMed 10952366Schenkman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatih Söke principal investigator
Gazi University
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Gazi University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Squares Test (time frame: 2 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03580486, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2018.