ParkinsonNCT05119803
The Relationship of Spine Posture and Mobility With Upper Extremity Functions in Parkinson's Patients
An observational study of Parkinson and Posture, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate whether spinal alignment and spinal mobility have an effect on upper extremity functions in Parkinson's patients. In the light of the data obtained as a result, we think that our study will also contribute to determining the factors that may cause upper limb dysfunctions seen in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson, Posture, Upper Extremity
- What is being tested?
- Spinal Mouse (IDIAG M360 ) and Nine Hole Peg Test
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Nov 2021to 15 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.
Who may be able to join
- For Parkinson's Patients;
- Being 18 years or older
- Receiving a diagnosis of Parkinson's made by a specialist neurologist
- Being able to walk independently
- Being between stages 1-4 on the Hoehn \& Yahr scale
- For the Control Group;
- Being 18 years or older
Who cannot join
- For Parkinson's Patients;
- 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
- For the Control Group;
- 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 Relationship of Spinal Alignment and Spinal Mobility on Upper Extremity Functions and Quality of Life in Patients With Parkinson's Disease.
The aim of this study is to investigate whether spinal alignment and spinal mobility have an effect on upper extremity functions in Parkinson's patients. In the light of the data obtained as a result, we think that our study will also contribute to determining the factors that may cause upper limb dysfunctions seen in Parkinson's patients and will guide new treatment-oriented studies to be carried out in the future.
Read the detailed description
Parkinson's disease is a neurodegenerative disease that occurs due to the influence of dopaminergic pathways, causing progressive deficits, especially in motor functions. The four main motor symptoms of Parkinson's are tremor, muscular rigidity, bradykinesia (slowing down of movements) and postural instability.
One of the inadequacies of these symptoms on patients is the disruption of the functions of the upper extremities. Since the formation of isometric force at parkinson disease is delayed, the reaction time is disrupted. In addition, patients exhibit sensory deficits, such as a decrease in the spatial and temporal tactile discrimination thresholds of the fingertips. Since patients tend to have difficulty initiating movement to a goal (akinesia), there are disorders of reaching and grasping it. There is also a lack of coordination between the timing of the movement components. In particular, tremor and rigidity can cause serious deficiencies during targeted activities in which the patient uses their upper limbs in their daily life. Incidence studies conducted to date have shown that Parkinson disease, causes various degrees of impairment in the manual skills of about 90% of individuals. In this context, the fine manipulative skills of the hand and the identification of components affecting the functions of the upper extremities in this group of diseases are important in the detection and management of the problem.
In Parkinson's disease, forward oblique posture, forward tilting of the head and neck, and scoliosis are common spinal deformities. The studies conducted have revealed that these deformities are directly proportional to the severity of the disease. In addition, the rigidity of the global trunk muscles may reduce the spinal mobility of the patients and may affect the independence measures in trunk-dependent activities. In this regard, it is important to analyze the spine sequence and mobility when monitoring patients in this group of diseases. At the same time, postural correction and balance reactions are also reduced due to postural changes, such as the development of flexion posture and reduced body rotation in Parkinson's disease. This condition causes Parkinson's patients to have difficulty maintaining their current posture and an increased risk of falling.
In a study conducted with healthy adults, upper extremity function was evaluated using the 'Jebsen Taylor Hand Function Test' in three different trunk postures (flexion, lateral flexion, neutral posture), and the best upper limb performance was obtained in neutral trunk posture. In another study, it was found that Pisa Syndrome (lateral flexion deformity of the trunk) was associated with both upper extremity functions and the level of independence in activities of daily living in Parkinson's disease. To the best of our group's knowledge, extremity dysfunctions, spinal posture and mobility involvement in Parkinson's disease have been well defined in the studies we have conducted in the literature, but we have not found any study investigating the effects of spinal alignment and spinal mobility on upper extremity functions and quality of life.
The aim of this study, which was planned accordingly, was to investigate: (A) spinal postural changes in Parkinson's disease, (B) changes in upper extremity functions in Parkinson's disease, (C) effects of spinal alignment and spinal mobility on upper extremity functions and quality of life in Parkinson's disease.
- Conditions
- Parkinson, Posture, Upper Extremity, Quality of Life
- Being tested
- Spinal Mouse (IDIAG M360 ), Nine Hole Peg Test
- Keywords
- Parkinson, Posture, Upper Extremity, Quality of Life, Spinal Curvatures
- Medical subject headings
- Spinal Curvatures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Mouse (IDIAG M360 )Device
This device is an electronic computer-aided measuring december that measures the range of motion of the spine, evaluates the angle and shape of the spine in the sagittal and frontal planes. The device provides data to the computer via Bluetooth, and the measured curvatures are displayed on the computer screen. The method has no medical risks or dangers. The device has two rotating wheels that follow the spinous protrusions of the spine, and the distance and angle measurements are transferred from the device to the computer.
Nine Hole Peg TestOther
The nine-hole peg test is a simple, fast and manual skill test that has been proven to be valid and reliable in measuring upper limb function in Parkinson's patients. While the patient is sitting, he is asked to insert nine sticks into the holes of the test box with nine holes one by one as fast as possible and remove them back when he is finished
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's patients | The cognitive status of the participants will be evaluated using the 'Standardized Mini Mental Test'.
The 'Unified Parkinson's Disease Assessment Scale Part 3' will be used to evaluate the motor function of Parkinson's patients.
Spinal posture will be assessed using the IDIAG M360 (IDIAG, Fehraltorf, Switzerland) Spinal Mouse. This device is an electronic computer aided measuring device that measures the range of motion of the spine and evaluates the angle and shape of the spine in the sagittal and frontal planes.
The upper extremity functions of Parkinson's patients will be evaluated with the '9-Hole Peg Test'.
A short version of PDQ-39, called the 8-item Parkinson's Disease Questionnaire (PDQ-8), will be applied to determine the quality of life of Parkinson's patients. The PDQ-8 consists of eight items that belong to each of the eight dimensions in the original PDQ-39. Receives: Device: Spinal Mouse (IDIAG M360 ); Other: Nine Hole Peg Test | |
| Healthy control group | The cognitive status of the participants will be evaluated using the 'Standardized Mini Mental Test'. This scale is frequently used for the general determination of the cognitive status of individuals rather than for the purpose of diagnosis.
The upper extremity functions of healty control group will be evaluated with the '9-Hole Peg Test'.
Spinal posture will be assessed using the IDIAG M360 (IDIAG, Fehraltorf, Switzerland) Spinal Mouse. This device is an electronic computer aided measuring device that measures the range of motion of the spine and evaluates the angle and shape of the spine in the sagittal and frontal planes. Receives: Device: Spinal Mouse (IDIAG M360 ); Other: Nine Hole Peg Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinal Mouse
This device is an electronic computer aided measuring device that measures the range of motion of the spine and evaluates the angle and shape of the spine in the sagittal and frontal planes. The device provides data to the computer via Bluetooth and the measured curvatures are displayed on the computer screen. The method has no medical risk or danger. The device has two rotating wheels that follow the spinous processes of the spine and the distance and angle measurements are transferred from the device to the computer. This information is then used to calculate the relative positions of each vertebra, the angles between the vertebrae, and the total angle of the frontal and sagittal plane curvatures with its software.
Measured: Measurements will begin on the estimated 3 November and will end on the estimated June 2022.
Secondary outcomes (1)
Nine Hole Peg Test
It is a simple, fast, manual skill test with proven validity and reliability. It is particularly sensitive to changes in upper extremity performance. The test material consists of nine small sticks made in standard sizes and a nine-hole board on which to place them. In the test, while the patient is in a sitting position, the patient is asked to line up the 9 sticks inside the box on the table as quickly as possible into the holes of the other box and immediately remove it after finishing. The test is started with the dominant hand. The time elapsed between the moment the hand touches the bars and the placing of the last bar in the box is recorded as the result of the test.
Measured: Measurements will begin on the estimated 3 November and will end on the estimated June 2022.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start3 Nov 2021
- Primary completion3 Feb 2022
- Study completion15 Jun 2022
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 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
- NCT05119803
- Sponsor's protocol ID
- 2021-335
- Status last verified
- Jul 2022
- First submitted
- 3 Nov 2021
- Last updated
- 8 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 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship of Spinal Alignment and Spinal Mobility on Upper Extremity Functions and Quality of Life in Patients With Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT05119803
- Acronym / sponsor ID
- 2021-335
- Conditions
- Parkinson, Posture, Upper Extremity, Quality of Life
- Keywords
- Parkinson, Posture, Upper Extremity, Quality of Life, Spinal Curvatures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 3 Feb 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 15 Nov 2021 (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 whether spinal alignment and spinal mobility have an effect on upper extremity functions in Parkinson's patients. In the light of the data obtained as a result, we think that our study will also contribute to determining the factors that may cause upper limb dysfunctions seen in Parkinson's patients and will guide new treatment-oriented studies to be carried out in the future.
Detailed description
Parkinson's disease is a neurodegenerative disease that occurs due to the influence of dopaminergic pathways, causing progressive deficits, especially in motor functions. The four main motor symptoms of Parkinson's are tremor, muscular rigidity, bradykinesia (slowing down of movements) and postural instability.
One of the inadequacies of these symptoms on patients is the disruption of the functions of the upper extremities. Since the formation of isometric force at parkinson disease is delayed, the reaction time is disrupted. In addition, patients exhibit sensory deficits, such as a decrease in the spatial and temporal tactile discrimination thresholds of the fingertips. Since patients tend to have difficulty initiating movement to a goal (akinesia), there are disorders of reaching and grasping it. There is also a lack of coordination between the timing of the movement components. In particular, tremor and rigidity can cause serious deficiencies during targeted activities in which the patient uses their upper limbs in their daily life. Incidence studies conducted to date have shown that Parkinson disease, causes various degrees of impairment in the manual skills of about 90% of individuals. In this context, the fine manipulative skills of the hand and the identification of components affecting the functions of the upper extremities in this group of diseases are important in the detection and management of the problem.
In Parkinson's disease, forward oblique posture, forward tilting of the head and neck, and scoliosis are common spinal deformities. The studies conducted have revealed that these deformities are directly proportional to the severity of the disease. In addition, the rigidity of the global trunk muscles may reduce the spinal mobility of the patients and may affect the independence measures in trunk-dependent activities. In this regard, it is important to analyze the spine sequence and mobility when monitoring patients in this group of diseases. At the same time, postural correction and balance reactions are also reduced due to postural changes, such as the development of flexion posture and reduced body rotation in Parkinson's disease. This condition causes Parkinson's patients to have difficulty maintaining their current posture and an increased risk of falling.
In a study conducted with healthy adults, upper extremity function was evaluated using the 'Jebsen Taylor Hand Function Test' in three different trunk postures (flexion, lateral flexion, neutral posture), and the best upper limb performance was obtained in neutral trunk posture. In another study, it was found that Pisa Syndrome (lateral flexion deformity of the trunk) was associated with both upper extremity functions and the level of independence in activities of daily living in Parkinson's disease. To the best of our group's knowledge, extremity dysfunctions, spinal posture and mobility involvement in Parkinson's disease have been well defined in the studies we have conducted in the literature, but we have not found any study investigating the effects of spinal alignment and spinal mobility on upper extremity functions and quality of life.
The aim of this study, which was planned accordingly, was to investigate: (A) spinal postural changes in Parkinson's disease, (B) changes in upper extremity functions in Parkinson's disease, (C) effects of spinal alignment and spinal mobility on upper extremity functions and quality of life in Parkinson's disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson's patients | – | Device: Spinal Mouse (IDIAG M360 ), Other: Nine Hole Peg TestThe cognitive status of the participants will be evaluated using the 'Standardized Mini Mental Test'. The 'Unified Parkinson's Disease Assessment Scale Part 3' will be used to evaluate the motor function of Parkinson's patients. Spinal posture will be assessed using the IDIAG M360 (IDIAG, Fehraltorf, Switzerland) Spinal Mouse. This device is an electronic computer aided measuring device that measures the range of motion of the spine and evaluates the angle and shape of the spine in the sagittal and frontal planes. The upper extremity functions of Parkinson's patients will be evaluated with the '9-Hole Peg Test'. A short version of PDQ-39, called the 8-item Parkinson's Disease Questionnaire (PDQ-8), will be applied to determine the quality of life of Parkinson's patients. The PDQ-8 consists of eight items that belong to each of the eight dimensions in the original PDQ-39. |
| Healthy control group | – | Device: Spinal Mouse (IDIAG M360 ), Other: Nine Hole Peg TestThe cognitive status of the participants will be evaluated using the 'Standardized Mini Mental Test'. This scale is frequently used for the general determination of the cognitive status of individuals rather than for the purpose of diagnosis. The upper extremity functions of healty control group will be evaluated with the '9-Hole Peg Test'. Spinal posture will be assessed using the IDIAG M360 (IDIAG, Fehraltorf, Switzerland) Spinal Mouse. This device is an electronic computer aided measuring device that measures the range of motion of the spine and evaluates the angle and shape of the spine in the sagittal and frontal planes. |
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.
Key inclusion criteria (7 listed)
- For Parkinson's Patients;
- Being 18 years or older
- Receiving a diagnosis of Parkinson's made by a specialist neurologist
- Being able to walk independently
- Being between stages 1-4 on the Hoehn \& Yahr scale
Key exclusion criteria (8 listed)
- For Parkinson's Patients;
- 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
- For the Control Group;
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 (IDIAG M360 )This device is an electronic computer-aided measuring december that measures the range of motion of the spine, evaluates the angle and shape of the spine in the sagittal and frontal planes. The device provides data to the computer via Bluetooth, and the measured curvatures are displayed on the computer screen. The method has no medical risks or dangers. The device has two rotating wheels that follow the spinous protrusions of the spine, and the distance and angle measurements are transferred from the device to the computer. | Device | Healthy control group, Parkinson's patients |
| Nine Hole Peg TestThe nine-hole peg test is a simple, fast and manual skill test that has been proven to be valid and reliable in measuring upper limb function in Parkinson's patients. While the patient is sitting, he is asked to insert nine sticks into the holes of the test box with nine holes one by one as fast as possible and remove them back when he is finished | Other | Healthy control group, Parkinson's patients |
Primary outcome
Spinal Mouse
Time frame: Measurements will begin on the estimated 3 November and will end on the estimated June 2022.
This device is an electronic computer aided measuring device that measures the range of motion of the spine and evaluates the angle and shape of the spine in the sagittal and frontal planes. The device provides data to the computer via Bluetooth and the measured curvatures are displayed on the computer screen. The method has no medical risk or danger. The device has two rotating wheels that follow the spinous processes of the spine and the distance and angle measurements are transferred from the device to the computer. This information is then used to calculate the relative positions of each vertebra, the angles between the vertebrae, and the total angle of the frontal and sagittal plane curvatures with its software.
1 secondary outcome
Nine Hole Peg Test
Time frame: Measurements will begin on the estimated 3 November and will end on the estimated June 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 8 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Parkinson
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.
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 and Posture, 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 7 inclusion and 8 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 8 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?
Spinal Mouse (time frame: Measurements will begin on the estimated 3 November and will end on the estimated June 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 8 Jul 2022.