The Relationship of Trunk Position Sense and Spinal Posture With Balance in Parkinson's

July 7, 2022 updated by: Mustafa Ertuğrul Yaşa, Gulhane School of Medicine

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.

Study Overview

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

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ankara, Turkey, 06310
        • Sağlık Bilimleri Üniversitesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Four Square Step Tests
  • One Leg Stance Test
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:
  • Four Square Step Tests
  • One Leg Stance Test

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
Spinal posture in the sagittal and frontal planes of the spine is evaluated for kyphosis, lordosis, and scoliosis.
30.03.2022
Trunk Position Sense
Time Frame: 30.03.2022
With the repositioning error test, the trunk is flexed to 30 degrees and the deviation angles of the person are measured.
30.03.2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

March 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

February 1, 2022

First Submitted That Met QC Criteria

February 1, 2022

First Posted (Actual)

February 10, 2022

Study Record Updates

Last Update Posted (Actual)

July 11, 2022

Last Update Submitted That Met QC Criteria

July 7, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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