Parkinson DiseaseNCT05233943
The Relationship of Trunk Position Sense and Spinal Posture With Balance in Parkinson's
An observational study of Parkinson Disease and Postural Kyphosis, Lumbosacral Region, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
Trial summary
The 4 main motor symptoms seen in Parkinson's patients are tremor, rigidity, postural instability and bradykinesia. In addition to these, another common symptom investigators encounter is balance problems. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Postural Kyphosis, Lumbosacral Region, Postural Kyphosis
- What is being tested?
- Spinal Mouse and Digital Inclinometer
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 30 Jun 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy individuals with similar age and body mass index values for Parkinson's patients who were diagnosed with Parkinson's disease according to the UK Parkinson's Disease Association Brain Bank criteria, followed in the Health Sciences University Gülhane Training and Research Hospital Neurology Department Parkinson's Polyclinic, and the control group will be included in the study. After the participants are informed about the study, a signed informed consent form will be obtained.
Who may be able to join
- Being 18 years or older
- Receiving a diagnosis of Parkinson Disease made by a specialist neurologist
- Being able to walk independently
- Being between stages 1-4 on the Hoehn \& Yahr scale
- -Being 18 years or older
Who cannot join
- Having any neurological disease other than Parkinson's
- Presence of cardiovascular, vestibular and musculoskeletal disease
- Having a score of <24 on the Standardized Mini Mental Test
- Having any disease that may affect balance, gait, posture and respiratory functions
- Using sedative - antidepressant medication that will impair physical well-being
- Having a score of <24 on the Standardized Mini Mental Test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effects of Trunk Position Sense and Spinal Posture on Balance Function in Parkinson's Patients
The 4 main motor symptoms seen in Parkinson's patients are tremor, rigidity, postural instability and bradykinesia. In addition to these, another common symptom investigators encounter is balance problems. Increasing balance problems can lead to falls and fractures over time, which will further reduce the independence of Parkinson's patients who are not already active enough and reduce their quality of life. For these reasons, it is very important that balance is achieved and sustainable. It has been found in previous studies that spinal posture and body position sensation are affected in Parkinson's patients. But to our knowledge, no study has been found in the literature to address the effect these have had on balance function. In our planned study, investigators aim to investigate the effects of spinal posture and body position sensation on balance function.
Read the detailed description
Resting tremor, muscular rigidity, bradykinesia (slowing of movements) and postural instability in Parkinson's patients constitute the 4 main motor symptoms of Parkinson's. In addition, he has been in various studies where posture is affected in Parkinson's disease and proprioceptive sensory loss is seen. These symptoms reduce the quality of life of patients and can also cause loss of balance. It is very important to maintain balance due to problems such as loss of balance in Parkinson's patients leading to falls and the resulting fractures. Determining the factors that may cause falls in Parkinson's patients is important because of its guidance in terms of preventive approaches and treatment options to be developed afterwards. In our research in literature, no study has been found in Parkinson's exploring the effects of spinal proprioceptive sensory loss and spinal posture on balance function. With this work planned accordingly:
(A) Loss of spinal proprioceptive sensation in Parkinson's, (B) Changes in spinal posture in Parkinson's and (C) It was intended to investigate the effects of spinal proprioceptive sensory loss and spinal postural changes on balance function in Parkinson's patients.
- Conditions
- Parkinson Disease, Postural Kyphosis, Lumbosacral Region, Postural Kyphosis, Postural Lordosis, Lumbosacral Region, Balance; Distorted
- Being tested
- Spinal Mouse and Digital Inclinometer
- Keywords
- Proprioception, Parkinson Disease, Posture
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Mouse and Digital InclinometerDevice
Also called Four Square Step Tests, One Leg Stance Test
The spinal mouse device is non-invasive and does not have any danger. The posture is evaluated by moving from top to bottom on the spine of the person. Data on the device is transferred to the computer via Bluetooth. The person's posture is evaluated in the sagittal plane by making maximum flexion, neutral stance and maximum extension positions, and in the frontal plane by lateral flexion to the right and left.
Digital Inclinometer; It is a non-invasive measurement tool that investigators measure the position sense of the body, which has two parts, one fixed and one movable. The immobile part of the digital inclinometer is placed at the sacrum and the movable part is placed at the T4 spine level. The person is made 30 degrees of trunk flexion. Then, he is expected to perform 5 repetitions of 30 degrees of trunk flexion with his eyes closed. Deviation angles are recorded.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's patients | The cognitive function of Parkinson's patients will be assessed using the "Standardized Mini Mental Test " .
The spinal posture will be evaluated using "IDIAG M360 Spinal Mouse " .
Parkinson's patients' spinal position sense will be assessed using a "repositioning error test" with J-TECH medical, Salt Lake City, USA Dual Digital Inclinometer.
Dynamic and static components of the balance function will be evaluated with 'four square step tests' and 'stand on one leg' tests respectively Receives: Device: Spinal Mouse and Digital Inclinometer | |
| Healthy control group | The cognitive function of Parkinson's patients will be assessed using the "Standardized Mini Mental Test " .
The spinal posture will be evaluated using "IDIAG M360 Spinal Mouse " .
Parkinson's patients' spinal position sense will be assessed using a "repositioning error test" with J-TECH medical, Salt Lake City, USA Dual Digital Inclinometer.
Dynamic and static components of the balance function will be evaluated with 'four square step tests' and 'stand on one leg' tests respectively Receives: Device: Spinal Mouse and Digital Inclinometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance function
The balance function of the person is evaluated with the four-square step test and the one-leg stance tests. In the test with 4 squares, the person takes a step forward, sideways and backwards, both clockwise and counterclockwise, by coming into the square. While the person is on his right foot, he raises his left foot and is asked to stand on one foot as long as he can stand. Then the reverse is done. The times of these two tests are recorded with a stopwatch.
Measured: 30.02.2022
Secondary outcomes (2)
Spinal Posture
Spinal posture in the sagittal and frontal planes of the spine is evaluated for kyphosis, lordosis, and scoliosis.
Measured: 30.03.2022
Trunk Position Sense
With the repositioning error test, the trunk is flexed to 30 degrees and the deviation angles of the person are measured.
Measured: 30.03.2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start1 Dec 2021
- Primary completion30 Mar 2022
- Study completion30 Jun 2022
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Ertuğrul Yaşa, Gulhane School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233943
- Sponsor's protocol ID
- 2022-48
- Status last verified
- Jul 2022
- First submitted
- 1 Feb 2022
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Trunk Position Sense and Spinal Posture on Balance Function in Parkinson's Patients
- ClinicalTrials.gov ID
- NCT05233943
- Acronym / sponsor ID
- 2022-48
- Conditions
- Parkinson Disease, Postural Kyphosis, Lumbosacral Region, Postural Kyphosis, Postural Lordosis, Lumbosacral Region, Balance; Distorted
- Keywords
- Proprioception, Parkinson Disease, Posture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 10 Feb 2022 (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 4 main motor symptoms seen in Parkinson's patients are tremor, rigidity, postural instability and bradykinesia. In addition to these, another common symptom investigators encounter is balance problems. Increasing balance problems can lead to falls and fractures over time, which will further reduce the independence of Parkinson's patients who are not already active enough and reduce their quality of life. For these reasons, it is very important that balance is achieved and sustainable. It has been found in previous studies that spinal posture and body position sensation are affected in Parkinson's patients. But to our knowledge, no study has been found in the literature to address the effect these have had on balance function. In our planned study, investigators aim to investigate the effects of spinal posture and body position sensation on balance function.
Detailed description
Resting tremor, muscular rigidity, bradykinesia (slowing of movements) and postural instability in Parkinson's patients constitute the 4 main motor symptoms of Parkinson's. In addition, he has been in various studies where posture is affected in Parkinson's disease and proprioceptive sensory loss is seen. These symptoms reduce the quality of life of patients and can also cause loss of balance. It is very important to maintain balance due to problems such as loss of balance in Parkinson's patients leading to falls and the resulting fractures. Determining the factors that may cause falls in Parkinson's patients is important because of its guidance in terms of preventive approaches and treatment options to be developed afterwards. In our research in literature, no study has been found in Parkinson's exploring the effects of spinal proprioceptive sensory loss and spinal posture on balance function. With this work planned accordingly:
(A) Loss of spinal proprioceptive sensation in Parkinson's, (B) Changes in spinal posture in Parkinson's and (C) It was intended to investigate the effects of spinal proprioceptive sensory loss and spinal postural changes on balance function in Parkinson's patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson's patients | – | Device: Spinal Mouse and Digital InclinometerThe cognitive function of Parkinson's patients will be assessed using the "Standardized Mini Mental Test " . The spinal posture will be evaluated using "IDIAG M360 Spinal Mouse " . Parkinson's patients' spinal position sense will be assessed using a "repositioning error test" with J-TECH medical, Salt Lake City, USA Dual Digital Inclinometer. Dynamic and static components of the balance function will be evaluated with 'four square step tests' and 'stand on one leg' tests respectively |
| Healthy control group | – | Device: Spinal Mouse and Digital InclinometerThe cognitive function of Parkinson's patients will be assessed using the "Standardized Mini Mental Test " . The spinal posture will be evaluated using "IDIAG M360 Spinal Mouse " . Parkinson's patients' spinal position sense will be assessed using a "repositioning error test" with J-TECH medical, Salt Lake City, USA Dual Digital Inclinometer. Dynamic and static components of the balance function will be evaluated with 'four square step tests' and 'stand on one leg' tests respectively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy individuals with similar age and body mass index values for Parkinson's patients who were diagnosed with Parkinson's disease according to the UK Parkinson's Disease Association Brain Bank criteria, followed in the Health Sciences University Gülhane Training and Research Hospital Neurology Department Parkinson's Polyclinic, and the control group will be included in the study. After the participants are informed about the study, a signed informed consent form will be obtained.
Key inclusion criteria (5 listed)
- Being 18 years or older
- Receiving a diagnosis of Parkinson Disease made by a specialist neurologist
- Being able to walk independently
- Being between stages 1-4 on the Hoehn \& Yahr scale
- -Being 18 years or older
Key exclusion criteria (6 listed)
- Having any neurological disease other than Parkinson's
- Presence of cardiovascular, vestibular and musculoskeletal disease
- Having a score of <24 on the Standardized Mini Mental Test
- Having any disease that may affect balance, gait, posture and respiratory functions
- Using sedative - antidepressant medication that will impair physical well-being
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 |
|---|---|---|
| Spinal Mouse and Digital InclinometerAlso: Four Square Step Tests, One Leg Stance TestThe spinal mouse device is non-invasive and does not have any danger. The posture is evaluated by moving from top to bottom on the spine of the person. Data on the device is transferred to the computer via Bluetooth. The person's posture is evaluated in the sagittal plane by making maximum flexion, neutral stance and maximum extension positions, and in the frontal plane by lateral flexion to the right and left. Digital Inclinometer; It is a non-invasive measurement tool that investigators measure the position sense of the body, which has two parts, one fixed and one movable. The immobile part of the digital inclinometer is placed at the sacrum and the movable part is placed at the T4 spine level. The person is made 30 degrees of trunk flexion. Then, he is expected to perform 5 repetitions of 30 degrees of trunk flexion with his eyes closed. Deviation angles are recorded. | Device | Healthy control group, Parkinson's patients |
Primary outcome
Balance function
Time frame: 30.02.2022
The balance function of the person is evaluated with the four-square step test and the one-leg stance tests. In the test with 4 squares, the person takes a step forward, sideways and backwards, both clockwise and counterclockwise, by coming into the square. While the person is on his right foot, he raises his left foot and is asked to stand on one foot as long as he can stand. Then the reverse is done. The times of these two tests are recorded with a stopwatch.
2 secondary outcomes
Spinal Posture
Time frame: 30.03.2022
Trunk Position Sense
Time frame: 30.03.2022
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 11 Jul 2022.
- 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.
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?
An observational study of Parkinson Disease and Postural Kyphosis, Lumbosacral Region, run by Gulhane School of Medicine 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 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 11 Jul 2022. 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?
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?
Balance function (time frame: 30.02.2022). 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 11 Jul 2022; AzTrials last refreshed its copy on 7 Nov 2026.