NCT05233943

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

July 11, 2022

Status Verified

July 1, 2022

Enrollment Period

4 months

First QC Date

February 1, 2022

Last Update Submit

July 7, 2022

Conditions

Keywords

ProprioceptionParkinson DiseasePosture

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Spinal Posture

    30.03.2022

  • Trunk Position Sense

    30.03.2022

Study Arms (2)

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

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

Device: Spinal Mouse and Digital Inclinometer

Interventions

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.

Also known as: Four Square Step Tests, One Leg Stance Test
Healthy control groupParkinson's patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sağlık Bilimleri Üniversitesi

Ankara, 06310, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof

Study Record Dates

First Submitted

February 1, 2022

First Posted

February 10, 2022

Study Start

December 1, 2021

Primary Completion

March 30, 2022

Study Completion

June 30, 2022

Last Updated

July 11, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations