NCT06859385

Brief Summary

In individuals diagnosed with Parkinson's disease, not being able to stand up especially after falling problems and staying in supine position cause loss of motivation and decrease in quality of life for patients. In order to prevent this problem in neurological diseases, it must be evaluated and treated by working functionally as a result of this evaluation. Parkinson's patients who will participate in the study will be referred from SANKO University Sani Konukoğlu Application and Research Hospital Neurology Polyclinic. The evaluations of the patients referred from the neurology polyclinic will be carried out in SANKO University Physiotherapy and Rehabilitation Department Research Laboratory. Socio-demographic information of the included patients will be obtained. Then, the supin to stand test will be used to measure the transition time from the supine position to the standing position and mobility status, the Activity-specific balance safety scale (ABC) for fear of falling, the Berg Balance Scale for balance assessment and the timed get up and walk test, 9-hole peg test for upper extremity functionality, manual muscle testing device for muscle strength of Dorsi flexor and Plantar flexor muscle groups in the ankle, Parkinson's Disease Quality of Life Questionnaire (PHA-39) for quality of life. The evaluations to be applied will be carried out by Dr. Lecturer. Member Hakan Polat will be carried out by Hakan Polat. Apart from the supine to stand test, the other tests to be performed are tests that evaluate the parameters that an individual should have for the transition from supine to standing position. These parameters are balance, muscle strength, ability to stand up without sitting, fine motor skill ability. Supin to stand test will be re-evaluated by a different physiotherapist in SANKO University Physiotherapy and Rehabilitation Department Research Laboratory after 1 week.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

February 1, 2025

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2025

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2025

Completed
Last Updated

March 5, 2025

Status Verified

February 1, 2025

Enrollment Period

28 days

First QC Date

February 27, 2025

Last Update Submit

February 27, 2025

Conditions

Keywords

parkinson

Outcome Measures

Primary Outcomes (7)

  • Supine to Stand test (SST)

    This test is performed to evaluate the transition of patients from supine to standing position. It measures the movement skill and how the skill is realised. For this test, we first place the patients in a supine position on a soft mat in a quiet and calm laboratory environment and ask them to stand up with the sentence 'Please stand up'. We record the time elapsed during this period. We ask the patient to repeat this test 2 times

    1 Years

  • Activity-specific balance confidence scale (ABC) Scale

    developed to measure balance confidence in indoor and outdoor activities. It is used to assess the fear of falling. It is a scale based on the respondents' assessment of how confidently they can perform 16 functional activities in and out of the home, ranging from 0 (unsafe) to 100 (completely confident). The ABC scale has been shown to be a consistent and reliable method. A scale value above 80% indicates that the balance is reliable

    1 Years

  • Timed Up and Go Test (SKYT-Timed Up and Go)

    The Timed Up and Go (SKYT) test is a balance test frequently used to assess functional mobility in the elderly. The test measures speed during many functions such as standing, walking, turning and sitting. The test is started with the patient's feet flat on the floor and arms resting on the armrests of the chair. The test asks the person to get up from the chair (seat height 45 cm, arm height 62 cm), walk 3 metres (10ft) at a safe and usual speed, turn, walk back and sit down in the chair, and the time is recorded in seconds. A shorter time indicates better balance and mobility. In stroke patients, a test time longer than 14 seconds indicates a high risk of falling. The subjects are asked to get up as fast as possible without running, turn at the end of the road and sit down again. For the value, the timer is pressed with the start command and the time is terminated when the subject is fully seated on the chair. The elapsed time will be rec

    1 Years

  • Berg Balance Scale (BBS)

    is one of the most basic tests that functionally assesses balance performance in the elderly population. The scale consists of 14 functional activities frequently used in daily life (standing up while sitting, standing without support, sitting without support, sitting while standing, sitting while standing, transferring, standing with eyes closed, standing with legs together, reaching forwards while standing, picking up objects from the floor, looking backwards, turning 360 degrees, standing on a stool on the right side, standing with one foot forward and standing on one foot). Activities are scored between 0-4. If the individual cannot perform the activity, 0 points are given and 4 points are given if the individual performs the activity independently. Low scores indicate impaired balance. The highest score is 56 and 0-20 points indicate impaired balance, 21-40 points indicate the presence of an acceptable balance, 41-56 points indicate the presence of a goo

    1 Years

  • 9 Hole Peg Test:

    The 9 Hole Peg Test (9-DPT), a hand dexterity test, was used to evaluate fine finger dexterity. The test consists of a platform with 9 holes and 9 sticks. The platform was placed directly in front of the individuals and adjusted so that the rods were on the dominant hand side and the holes were on the non-dominant hand side. After the test rules were explained to the individuals, the individuals were given the opportunity to practice before the application. Individuals were asked to insert the rods on the board as fast as possible. The test results were recorded by measuring the time from the moment the individuals touched the first stick to the moment the last stick was attached to the platform with a stopwatch. Then, they were asked to remove the 9 rods one by one with the same hand and the removal time was recorded. The test will be applied for the non-dominant hand using the same method; the platform will be rotated in front of the non-dominant hand this time.

    1 years

  • Parkinson's Quality of Life Questionnaire:

    Parkinson's Disease Questionnaire-39 (PDQ-39) was applied to assess the quality of life of the patients. PDQ-39 consists of eight sections assessing mobility, activities of daily living, mood, stigma, perception of social support, communication and body discomfort. Each section is scored separately between 0 and 100. Lower scores indicate better quality of life. For the overall assessment of quality of life, the total PDQ index can be calculated by summing the section scores. This score can also be standardised to a value between 0 and 100. Again, lower scores indicate better quality of life .

    1 Years

  • Manual muscle test device:

    muscle strength (right foot dorsi flexion, left foot dorsi flexion, right foot plantar flexion, left foot plantar flexion) will be measured with Commander Echo brand manual muscle test device. The participant will be asked to resist the resistance as much as possible and the maximum force will be recorded. After the participants are informed, 1 trial will be performed. Muscle strength measurement will be repeated 3 times and the average value will be recorded in kilograms.

    1 Years

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

PATIENTS WITH PARKINSON'S DISEASE ADMITTED TO THE NEUROLOGY OUTPATIENT CLINIC OF SANKO UNİVERSİTESİ SANİ KONUKOĞLU APPLICATION AND RESEARCH HOSPITAL

You may qualify if:

  • Patients older than 40 years with a renewed diagnosis of Parkinson's disease
  • Patients who have not changed medication in the last 2 months
  • Patients who can walk with or without an assistive device

You may not qualify if:

  • The presence of psychological or pathological conditions that can directly affect functional activity and cause metabolic changes
  • Pregnant or breastfeeding women
  • Alcohol and substance abusers
  • Cardiovascular or metabolic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SANKO University

Gaziantep, Gazi̇azntep, 27500, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapy and Rehabilitation Department, Assistant Professor

Study Record Dates

First Submitted

February 27, 2025

First Posted

March 5, 2025

Study Start

February 1, 2025

Primary Completion

March 1, 2025

Study Completion

March 10, 2025

Last Updated

March 5, 2025

Record last verified: 2025-02

Locations