Parkinson DiseaseNCT06490809
Minimal Clinically Important Difference of the Box and Block Test in Parkinson
A study testing Physiotherapy in people with Parkinson Disease, run by Emre Şenocak at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the level of clinical change in gross manual skills of Parkinson's patients who receive conventional physiotherapy. For this purpose, the Box-Block Test will be used, and the amount of change that must occur in the patient's hand functions will be determined for the test to be… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being Hoehn \& Yahr Stage between 1-3,
- Individuals in the "On" phase,
- Those who were not exposed to any physiotherapy intervention during the initial assessment
Who cannot join
- Mini-mental status assessment \< 24 points;
- Presence of severe dyskinesia,
- Those who experience fluctuations in the on-off phase,
- Those who have undergone stereotaxic brain surgery for Parkinson's,
- Individuals with changes in dopamine dose within three months,
- Presence of unstable cardiac and respiratory disease
- Those with an orthopedic problem or a history of surgery affecting upper extremity performance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Özel Öz İstanbul Tıp Merkezi
Istanbul, 34230
Adem Aktürk, PhD, +90 533 310 23 15, aakturk@gelisim.edu.tr
About this study
Official title: Examining the Clinical Significance of the Change in Manual Dexterity of Parkinson's Patients Receiving Conventional Physiotherapy
The aim of this study is to examine the level of clinical change in gross manual skills of Parkinson's patients who receive conventional physiotherapy. For this purpose, the Box-Block Test will be used, and the amount of change that must occur in the patient's hand functions will be determined for the test to be considered clinically meaningful.
Patients will continue their routine physical therapy sessions and the researchers will not interfere with this program. The treatment program will be created by the clinical specialist physician and physiotherapist.
Upper extremity rehabilitation programs for Parkinson's patients generally consist of methods such as stretching, strengthening, reaching, coordination and recreational activities. Patients will receive physiotherapy for 30 sessions.
- Conditions
- Parkinson Disease
- Being tested
- Physiotherapy
- Keywords
- Parkinson, Box and Block Test, Minimal Clinically Important Difference
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyOther
Parkinson\'s upper extremity rehabilitation generally consists of stretching, strengthening, coordination, recreational activities and skill activities. Exercises will be prescribed by the clinical specialist physician and physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Routine Physiotherapy Group | Experimental | No action will be taken by the researchers on this group's treatment program. Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Box and Block Test
This test assesses gross manual dexterity. The number of wooden blocks moved during 60 seconds gives the total score. A high score indicates good dexterity.
Measured: Baseline of the study
Box and Block Test
This test assesses gross manual dexterity. The number of wooden blocks moved during 60 seconds gives the total score. A high score indicates good dexterity.
Measured: 6 weeks (5 session days for 6 weeks)
Global Rating of Patient-Perceived Changes (GRP-PC)
GRP-PC will used to assess patient-perceived hand dexterity changes after the routine intervention. The patient will first asked, "Has your hand dexterity changed compared to when you did not receive interventions?". If the answer is no, the person will given a score of 0 (i.e. no change). In the case of positive response, the patient will asked, "How much better or worse is your hand dexterity" and the patient response will scored on the following 14-point Likert scale: +7 (very much better), +6 (much better), +5 (better), +4 (relatively better), +3 (somewhat better), +2 (a little better), +1 (very little better), -1 (very little worse), -2 (a little worse), -3 (somewhat worse), -4 (relatively worse), -5 (worse), -6 (much worse), and -7 (very much worse). This form will only be used to classify patients' satisfaction with treatment at the end of the study.
Measured: 6 weeks (5 session days for 6 weeks)
Secondary outcomes (1)
Demographic Data Form
This form was created by researchers and it consist of personal informations such as gender, education, age, body mass index, dominant and affected extremity, disease duration, using medicine
Measured: Baseline of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start1 Oct 2024
- Primary completion1 Jan 2025
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emre Şenocak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emre Şenocak, Karadeniz Technical University
- Investigators
- Murat Emirzeoğlu, PhD, Study chair, Karadeniz Technical UniversityTuğba Eyigürbüz, PhD, Study chair, Bağcılar Education and Research HospitalAdem Aktürk, PhD, Study chair, İstanbul Gelişim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490809
- Sponsor's protocol ID
- E-13562490-050.01.04-51
- Status last verified
- Mar 2025
- First submitted
- 26 Jun 2024
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Clinical Significance of the Change in Manual Dexterity of Parkinson's Patients Receiving Conventional Physiotherapy
- ClinicalTrials.gov ID
- NCT06490809
- Acronym / sponsor ID
- E-13562490-050.01.04-51
- Conditions
- Parkinson Disease
- Keywords
- Parkinson, Box and Block Test, Minimal Clinically Important Difference
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Emre ŞenocakUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 8 Jul 2024 (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 examine the level of clinical change in gross manual skills of Parkinson's patients who receive conventional physiotherapy. For this purpose, the Box-Block Test will be used, and the amount of change that must occur in the patient's hand functions will be determined for the test to be considered clinically meaningful.
Patients will continue their routine physical therapy sessions and the researchers will not interfere with this program. The treatment program will be created by the clinical specialist physician and physiotherapist.
Upper extremity rehabilitation programs for Parkinson's patients generally consist of methods such as stretching, strengthening, reaching, coordination and recreational activities. Patients will receive physiotherapy for 30 sessions.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Routine Physiotherapy Group | Experimental | Other: PhysiotherapyNo action will be taken by the researchers on this group's treatment program. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being Hoehn \& Yahr Stage between 1-3,
- Individuals in the "On" phase,
- Those who were not exposed to any physiotherapy intervention during the initial assessment
Key exclusion criteria (7 listed)
- Mini-mental status assessment \< 24 points;
- Presence of severe dyskinesia,
- Those who experience fluctuations in the on-off phase,
- Those who have undergone stereotaxic brain surgery for Parkinson's,
- Individuals with changes in dopamine dose within three months,
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 |
|---|---|---|
| PhysiotherapyParkinson\'s upper extremity rehabilitation generally consists of stretching, strengthening, coordination, recreational activities and skill activities. Exercises will be prescribed by the clinical specialist physician and physiotherapist. | Other | Routine Physiotherapy Group |
Primary outcome
Box and Block Test
Time frame: Baseline of the study
This test assesses gross manual dexterity. The number of wooden blocks moved during 60 seconds gives the total score. A high score indicates good dexterity.
Box and Block Test
Time frame: 6 weeks (5 session days for 6 weeks)
This test assesses gross manual dexterity. The number of wooden blocks moved during 60 seconds gives the total score. A high score indicates good dexterity.
Global Rating of Patient-Perceived Changes (GRP-PC)
Time frame: 6 weeks (5 session days for 6 weeks)
GRP-PC will used to assess patient-perceived hand dexterity changes after the routine intervention. The patient will first asked, "Has your hand dexterity changed compared to when you did not receive interventions?". If the answer is no, the person will given a score of 0 (i.e. no change). In the case of positive response, the patient will asked, "How much better or worse is your hand dexterity" and the patient response will scored on the following 14-point Likert scale: +7 (very much better), +6 (much better), +5 (better), +4 (relatively better), +3 (somewhat better), +2 (a little better), +1 (very little better), -1 (very little worse), -2 (a little worse), -3 (somewhat worse), -4 (relatively worse), -5 (worse), -6 (much worse), and -7 (very much worse). This form will only be used to classify patients' satisfaction with treatment at the end of the study.
1 secondary outcome
Demographic Data Form
Time frame: Baseline of the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
Murat Emirzeoğlu, PhD study chair
Karadeniz Technical University
Tuğba Eyigürbüz, PhD study chair
Bağcılar Education and Research Hospital
Adem Aktürk, PhD study chair
İstanbul Gelişim University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy in people with Parkinson Disease, run by Emre Şenocak at 1 site 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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emre Şenocak, PhD (+90 553 569 56 92, emre.senocak@windowslive.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Box and Block Test (time frame: Baseline of the study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2025.