Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05233943
Other study ID # 2022-48
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2021
Est. completion date June 30, 2022

Study information

Verified date July 2022
Source Gulhane School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date June 30, 2022
Est. primary completion date March 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Device:
Spinal Mouse and Digital Inclinometer
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.

Locations

Country Name City State
Turkey Saglik Bilimleri Üniversitesi Ankara

Sponsors (1)

Lead Sponsor Collaborator
Gulhane School of Medicine

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 30.02.2022
Secondary Spinal Posture Spinal posture in the sagittal and frontal planes of the spine is evaluated for kyphosis, lordosis, and scoliosis. 30.03.2022
Secondary Trunk Position Sense With the repositioning error test, the trunk is flexed to 30 degrees and the deviation angles of the person are measured. 30.03.2022
See also
  Status Clinical Trial Phase
Completed NCT05415774 - Combined Deep Brain Stimulation in Parkinson's Disease N/A
Recruiting NCT04691661 - Safety, Tolerability, Pharmacokinetics and Efficacy Study of Radotinib in Parkinson's Disease Phase 2
Active, not recruiting NCT05754086 - A Multidimensional Study on Articulation Deficits in Parkinsons Disease
Completed NCT04045925 - Feasibility Study of the Taïso Practice in Parkinson's Disease N/A
Recruiting NCT04194762 - PARK-FIT. Treadmill vs Cycling in Parkinson´s Disease. Definition of the Most Effective Model in Gait Reeducation N/A
Completed NCT02705755 - TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH) Phase 2
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Recruiting NCT05830253 - Free-living Monitoring of Parkinson's Disease Using Smart Objects
Recruiting NCT03272230 - Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System N/A
Recruiting NCT06139965 - Validity and Reliability of the Turkish Version of the Comprehensive Coordination Scale in Parkinson's Patients
Completed NCT04580849 - Telerehabilitation Using a Dance Intervention in People With Parkinson's Disease N/A
Completed NCT04477161 - Effect of Ketone Esters in Parkinson's Disease N/A
Completed NCT03980418 - Evaluation of a Semiconductor Camera for the DaTSCAN™ Exam N/A
Completed NCT04942392 - Digital Dance for People With Parkinson's Disease During the COVID-19 Pandemic N/A
Terminated NCT03446833 - LFP Beta aDBS Feasibility Study N/A
Completed NCT03497884 - Individualized Precise Localization of rTMS on Primary Motor Area N/A
Completed NCT05538455 - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases N/A
Recruiting NCT04997642 - Parkinson's Disease and Movement Disorders Clinical Database
Completed NCT04117737 - A Pilot Study of Virtual Reality and Antigravity Treadmill for Gait Improvement in Parkinson N/A
Recruiting NCT03618901 - Rock Steady Boxing vs. Sensory Attention Focused Exercise N/A