- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05233943
The Relationship of Trunk Position Sense and Spinal Posture With Balance in Parkinson's
Investigation of the Effects of Trunk Position Sense and Spinal Posture on Balance Function in Parkinson's Patients
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Ankara, Turkey, 06310
- Sağlık Bilimleri Üniversitesi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria For Parkinson's patients:
- 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
Inclusion Criteria For Healthy Volunteers :
-Being 18 years or older
Exclusion Criteria 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
Exclusion Criteria For Healthy Volunteers :
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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 |
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.
Other Names:
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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 |
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
30.02.2022
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spinal Posture
Time Frame: 30.03.2022
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Spinal posture in the sagittal and frontal planes of the spine is evaluated for kyphosis, lordosis, and scoliosis.
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30.03.2022
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Trunk Position Sense
Time Frame: 30.03.2022
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With the repositioning error test, the trunk is flexed to 30 degrees and the deviation angles of the person are measured.
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30.03.2022
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-48
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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