ParkinsonNCT06848257
Posture Exercises in Parkinson's Disease
A study testing Exercise in people with Parkinson, run by Yuksek Ihtisas Hospital at 1 site in Turkey (Türkiye).
Trial summary
The research was planned as a quasi-experimental study to investigate the effects of postural exercises on body image and neck and trunk position sense in Parkinson's patients. It was decided to conduct the study with Parkinson's patients over the age of 50 who applied to the neurology clinic. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Parkinson
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2023to 15 May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being over 50 years old,
- Being diagnosed with Parkinson's disease by a physician,
- Stage 1-4 according to the modified Hoehn-Yahr staging scale
- Having received 24≥ from the Mini Mental test
Who cannot join
- Presence of another accompanying neurological disease,
- Having significant musculoskeletal system problems,
- Having any known cognitive problem or having a score of ≤23 on the Mini Mental Test
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Postural Exercises on the Perception of Verticality in Parkinson's Disease
The research was planned as a quasi-experimental study to investigate the effects of postural exercises on body image and neck and trunk position sense in Parkinson's patients.
It was decided to conduct the study with Parkinson's patients over the age of 50 who applied to the neurology clinic. After the power analysis for the research, it was planned to reach 36 participants. Participants' consent to participate in the study will be obtained through the Informed Volunteer Consent Form prepared by the researchers. Demographic information of participants who consent to participate in the study will be collected. Then, the disease levels and severity of the participants will be determined using the Modified Hoehn Yahr Staging Scale and the Unified Parkinson's Disease Assessment Scale. Subjective Visual Vertical Perception, Subjective Postural Perception and Subjective Haptic Perception evaluations to evaluate the body image of patients; Clinometer application and neck and trunk proprioception evaluations will be applied as preliminary tests to evaluate neck and trunk position sense. Posture exercises planned by the researchers will be applied to the participants, whose pre-tests are completed, three days a week for eight weeks. Preliminary tests performed after eight weeks of exercise will be repeated. All data obtained will be recorded in the Participant Data Record form. Differences in changes in tests performed at eight-week intervals will be investigated with appropriate statistical methods.
- Conditions
- Parkinson
- Being tested
- Exercise
- Keywords
- Parkinson, Postural exercises, Verticality, Position sense
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
postural exercises
| Study group | Role | What they receive |
|---|---|---|
| Clinic research | Experimental | Not described Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic characteristics of the individuals participating in the study
Demographic information of the patients such as age(years), height (in meters) and weight (in kilograms) and education level (primary school, secondary school, high scool, etc) will be recorded. Weight and height will be used to calculate Body mass index (BMI) (kg/m^2). BMI will be used to compare body compositions of patients. Mini Mental Test; used to evaluate cognitive performance.Those who score 24 points or above on the test (being able to understand and apply the given commands) will be included in the study.
Measured: All evaluations will be done before and after the treatment (8 weeks)
Evaluations about Parkinson's disease
Disease staging of individuals will be done with the Modified Hoehn and Yahr Scale (MH\&YS). In this scale, patients are divided into 5 main categories according to their level of independence status.According to the scale, patients who can walk without support (at most stage 3) will be included in the study. And disease severity will be measured by Unified Parkinson's Disease Rating Scale(UPDRS) .The scale consists of 4 sections to evaluate different systems. These are; emotion-thought (total 16 points), motor (total 92 points), daily life (total 52 points), treatment and complications (total 23 points). Each evaluation step is scored between 0 and 4. A low total score indicates that the severity of the disease is low, while an increase in the total score indicates that the disease is severe.
Measured: All evaluations will be done before and after the treatment (8 weeks)
Subjective verticality perception evaluations
Assessment of Subjective Vertical Perception:The Bucket Test evaluates subjective visual verticality by having participants align a vertical line inside a bucket without external visual cues.For Postural Vertical, an inclinometer measures deviations as participants adjust their torso to perceived verticality in 0°, 30° right, and 30° left positions.Haptic Vertical is tested by blindfolded participants aligning a rod to reference angles (0°, 45° left, 45° right).Scored by taking the absolute value of the deviations from three trials
Measured: All evaluations will be done before and after the treatment (8 weeks)
proprioception evaluations
Position Sense (proprioception) is assessed by repositioning the neck (C7) and trunk (L1) to a 30° flexion target. Scored by taking the absolute value of the deviations from three trials.
Measured: All evaluations will be done before and after the treatment (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start15 Jul 2023
- Primary completion15 Aug 2023
- Study completion15 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParkinsonStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuksek Ihtisas Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Yuksek Ihtisas University
- Responsible party
- Principal investigator, Aysegul Gokturk Usta, Yuksek Ihtisas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848257
- Sponsor's protocol ID
- 2023/03/10
- Status last verified
- Feb 2025
- First submitted
- 14 Jan 2025
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no reason.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Postural Exercises on the Perception of Verticality in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06848257
- Acronym / sponsor ID
- 2023/03/10
- Conditions
- Parkinson
- Keywords
- Parkinson, Postural exercises, Verticality, Position sense
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Yuksek Ihtisas HospitalUniversity, hospital or other
- Collaborators
- Yuksek Ihtisas University
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 May 2025 (estimated)
- First posted
- 27 Feb 2025 (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 research was planned as a quasi-experimental study to investigate the effects of postural exercises on body image and neck and trunk position sense in Parkinson's patients.
It was decided to conduct the study with Parkinson's patients over the age of 50 who applied to the neurology clinic. After the power analysis for the research, it was planned to reach 36 participants. Participants' consent to participate in the study will be obtained through the Informed Volunteer Consent Form prepared by the researchers. Demographic information of participants who consent to participate in the study will be collected. Then, the disease levels and severity of the participants will be determined using the Modified Hoehn Yahr Staging Scale and the Unified Parkinson's Disease Assessment Scale. Subjective Visual Vertical Perception, Subjective Postural Perception and Subjective Haptic Perception evaluations to evaluate the body image of patients; Clinometer application and neck and trunk proprioception evaluations will be applied as preliminary tests to evaluate neck and trunk position sense. Posture exercises planned by the researchers will be applied to the participants, whose pre-tests are completed, three days a week for eight weeks. Preliminary tests performed after eight weeks of exercise will be repeated. All data obtained will be recorded in the Participant Data Record form. Differences in changes in tests performed at eight-week intervals will be investigated with appropriate statistical methods.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinic research | Experimental | Other: Exercise |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being over 50 years old,
- Being diagnosed with Parkinson's disease by a physician,
- Stage 1-4 according to the modified Hoehn-Yahr staging scale
- Having received 24≥ from the Mini Mental test
Key exclusion criteria (3 listed)
- Presence of another accompanying neurological disease,
- Having significant musculoskeletal system problems,
- Having any known cognitive problem or having a score of ≤23 on the Mini Mental Test
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 |
|---|---|---|
| Exercisepostural exercises | Other | Clinic research |
Primary outcome
Demographic characteristics of the individuals participating in the study
Time frame: All evaluations will be done before and after the treatment (8 weeks)
Demographic information of the patients such as age(years), height (in meters) and weight (in kilograms) and education level (primary school, secondary school, high scool, etc) will be recorded. Weight and height will be used to calculate Body mass index (BMI) (kg/m^2). BMI will be used to compare body compositions of patients. Mini Mental Test; used to evaluate cognitive performance.Those who score 24 points or above on the test (being able to understand and apply the given commands) will be included in the study.
Evaluations about Parkinson's disease
Time frame: All evaluations will be done before and after the treatment (8 weeks)
Disease staging of individuals will be done with the Modified Hoehn and Yahr Scale (MH\&YS). In this scale, patients are divided into 5 main categories according to their level of independence status.According to the scale, patients who can walk without support (at most stage 3) will be included in the study. And disease severity will be measured by Unified Parkinson's Disease Rating Scale(UPDRS) .The scale consists of 4 sections to evaluate different systems. These are; emotion-thought (total 16 points), motor (total 92 points), daily life (total 52 points), treatment and complications (total 23 points). Each evaluation step is scored between 0 and 4. A low total score indicates that the severity of the disease is low, while an increase in the total score indicates that the disease is severe.
Subjective verticality perception evaluations
Time frame: All evaluations will be done before and after the treatment (8 weeks)
Assessment of Subjective Vertical Perception:The Bucket Test evaluates subjective visual verticality by having participants align a vertical line inside a bucket without external visual cues.For Postural Vertical, an inclinometer measures deviations as participants adjust their torso to perceived verticality in 0°, 30° right, and 30° left positions.Haptic Vertical is tested by blindfolded participants aligning a rod to reference angles (0°, 45° left, 45° right).Scored by taking the absolute value of the deviations from three trials
proprioception evaluations
Time frame: All evaluations will be done before and after the treatment (8 weeks)
Position Sense (proprioception) is assessed by repositioning the neck (C7) and trunk (L1) to a 30° flexion target. Scored by taking the absolute value of the deviations from three trials.
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 3 Mar 2025.
- Individual participant dataSharing planned: No. There is no reason.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Parkinson, run by Yuksek Ihtisas Hospital 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 4 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 3 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?
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?
Demographic characteristics of the individuals participating in the study (time frame: All evaluations will be done before and after the treatment (8 weeks)). The study lists 4 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 3 Mar 2025.