NCT05119803

Brief 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 Parkinson's patients and will guide new treatment-oriented studies to be carried out in the future.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 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

First Submitted

Initial submission to the registry

November 3, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

November 3, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 15, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2022

Completed
Last Updated

July 8, 2022

Status Verified

July 1, 2022

Enrollment Period

3 months

First QC Date

November 3, 2021

Last Update Submit

July 7, 2022

Conditions

Keywords

ParkinsonPostureUpper ExtremityQuality of LifeSpinal Curvatures

Outcome Measures

Primary Outcomes (1)

  • 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.

    Measurements will begin on the estimated 3 November and will end on the estimated June 2022.

Secondary Outcomes (1)

  • Nine Hole Peg Test

    Measurements will begin on the estimated 3 November and will end on the estimated June 2022.

Other Outcomes (1)

  • Parkinson's Disease Questionnaire (PDQ-8)

    Measurements will begin on the estimated 3 November and will end on the estimated June 2022.

Study Arms (2)

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.

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.

Device: Spinal Mouse (IDIAG M360 )Other: Nine Hole Peg Test

Interventions

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.

Healthy control groupParkinson's patients

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

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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sağlık Bilimleri Üniversitesi

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Spinal Curvatures

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal 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

November 3, 2021

First Posted

November 15, 2021

Study Start

November 3, 2021

Primary Completion

February 3, 2022

Study Completion

June 15, 2022

Last Updated

July 8, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations