Parkinson DiseaseNCT06139965
Validity and Reliability of the Turkish Version of the Comprehensive Coordination Scale in Parkinson's Patients
An observational study of Parkinson Disease, run by Akdeniz University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the Turkish adaptation of the Comprehensive Coordination Scale and its validity and reliability in Parkinson's patients. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Validity and Reliability
- How many people
- 30 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 5 Sep 2023to 30 Jan 2024
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Parkinson's patients
Who may be able to join
- Diagnosed with Parkinson's,
- Mini mental test score over 24,
- Those who have not experienced any serious neurological or orthopedic problems in the last 6 months,
- İndividuals who agreed to participate in the study
Who cannot join
- Mini mental test score <24,
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Gokce Yagmur Gunes Gencer
Antalya, 07070
Gokce Yagmur Gunes Gencer, +905369355050, g.yagmur.g@gmail.com
- Recruiting
Ozel Termessos Hastanesi
Antalya
Nazan Ş Erdem, MD, +90242 212 18 18
About this study
The aim of this study is to investigate the Turkish adaptation of the Comprehensive Coordination Scale and its validity and reliability in Parkinson's patients.
Read the detailed description
A Turkish version of the Comprehensive Coordination Scale will be made. Then, Comprehensive Coordination Scale, 9-Hole Peg Test, Timed Up and Go Test, Berg Balance Scale, Functional Reaching Test and Modified Hoehn and Yahr Scale will be applied to patients with Parkinson's, respectively. In order to determine the reliability of the scale, only the "Comprehensive Coordination Scale" will be video recorded during the first evaluation and inter-rater reliability will be performed by another physiotherapist. For test-retest reliability, patients will be evaluated seven days later by the first physiotherapist who made the evaluation by watching the video again.
- Conditions
- Parkinson Disease
- Being tested
- Validity and Reliability
- Keywords
- Comprehensive Coordination Scale, Validity, Reliability
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Validity and ReliabilityOther
Assessment study
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehensive Coordination Scale
The Comprehensive Coordination Scale (CCS) is a measure of coordination of multiple body segments at both motor performance (endpoint movement) and quality of movement (joint rotations and interjoint coordination) levels based on observational kinematics.
Measured: Baseline (First assessment)
Secondary outcomes (5)
9 Hole Peg Test
The Nine-Hole Peg Test (9-HPT) is a standardized, quantitative assessment used to measure finger dexterity.
Measured: Baseline (First assessment)
Timed Up and Go Test (TUG)
The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk in older adults.
Measured: Baseline (First assessment)
Berg Balance Test
The Berg Balance Scale (BBS) is a 14-item objective measure that assesses static balance and fall risk in adults.
Measured: Baseline (First assessment)
Functional Reach Test
The Functional Reach Test assesses a patient's stability by measuring the maximum distance an individual can reach forward while standing in a fixed position.
Measured: Baseline (First assessment)
Modified Hoehn and Yahr Scale
The Hoehn and Yahr scale is used to describe the symptom progression of Parkinson disease
Measured: Baseline (First assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start5 Sep 2023
- Primary completion5 Jan 2024 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Akdeniz 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gokce Yagmur Gunes Gencer, Akdeniz University
- Investigators
- Gökçe Yağmur Güneş Gencer, Assist.Prof., Principal investigator, Akdeniz UniversityLütfiye Akkurt, Assist.Prof., Study chair, Kutahya Health Sciences UniversityHayri Aktaş, MSc, Study chair, Akdeniz UniversityNazan Ş Erdem, MD, Study chair, Özel Termessos Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06139965
- Sponsor's protocol ID
- KAEK-633
- Status last verified
- Nov 2023
- First submitted
- 15 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alouche SR, Molad R, Demers M, Levin MF. Development of a Comprehensive Outcome Measure for Motor Coordination; Step 1: Three-Phase Content Validity Process. Neurorehabil Neural Repair. 2021 Feb;35(2):185-193. doi: 10.1177/1545968320981955. Epub 2020 Dec 22.
PubMed 33349134
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Turkish Version of the Comprehensive Coordination Scale in Parkinson's Patients
- ClinicalTrials.gov ID
- NCT06139965
- Acronym / sponsor ID
- KAEK-633
- Conditions
- Parkinson Disease
- Keywords
- Comprehensive Coordination Scale, Validity, Reliability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 5 Jan 2024 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 18 Nov 2023 (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 aim of this study is to investigate the Turkish adaptation of the Comprehensive Coordination Scale and its validity and reliability in Parkinson's patients.
Detailed description
A Turkish version of the Comprehensive Coordination Scale will be made. Then, Comprehensive Coordination Scale, 9-Hole Peg Test, Timed Up and Go Test, Berg Balance Scale, Functional Reaching Test and Modified Hoehn and Yahr Scale will be applied to patients with Parkinson's, respectively. In order to determine the reliability of the scale, only the "Comprehensive Coordination Scale" will be video recorded during the first evaluation and inter-rater reliability will be performed by another physiotherapist. For test-retest reliability, patients will be evaluated seven days later by the first physiotherapist who made the evaluation by watching the video again.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson's patients
Key inclusion criteria (4 listed)
- Diagnosed with Parkinson's,
- Mini mental test score over 24,
- Those who have not experienced any serious neurological or orthopedic problems in the last 6 months,
- İndividuals who agreed to participate in the study
Key exclusion criteria (1 listed)
- Mini mental test score <24,
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 |
|---|---|---|
| Validity and ReliabilityAssessment study | Other | – |
Primary outcome
Comprehensive Coordination Scale
Time frame: Baseline (First assessment)
The Comprehensive Coordination Scale (CCS) is a measure of coordination of multiple body segments at both motor performance (endpoint movement) and quality of movement (joint rotations and interjoint coordination) levels based on observational kinematics.
5 secondary outcomes
9 Hole Peg Test
Time frame: Baseline (First assessment)
Timed Up and Go Test (TUG)
Time frame: Baseline (First assessment)
Berg Balance Test
Time frame: Baseline (First assessment)
Functional Reach Test
Time frame: Baseline (First assessment)
Modified Hoehn and Yahr Scale
Time frame: Baseline (First assessment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Results publication: PubMed 33349134Alouche SR, Molad R, Demers M, Levin MF. Development of a Comprehensive Outcome Measure for Motor Coordination; Step 1: Three-Phase Content Validity Process. Neurorehabil Neural Repair. 2021 Feb;35(2):185-193. doi: 10.1177/1545968320981955. Epub 2020 Dec 22.
- Individual participant dataSharing planned: No
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
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.
Gökçe Yağmur Güneş Gencer, Assist.Prof. principal investigator
Akdeniz University
Lütfiye Akkurt, Assist.Prof. study chair
Kutahya Health Sciences University
Hayri Aktaş, MSc study chair
Akdeniz University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Akdeniz University at 2 sites in Turkey (Türkiye).
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gökçe Yağmur Güneş Gencer, Assist.Prof. (+90 242 227 4400 ext. 4187, gokcegunes@akdeniz.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehensive Coordination Scale (time frame: Baseline (First assessment)). 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 NCT06139965, which also lists 1 linked publication.
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 18 Nov 2023.