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NCT Number: NCT05703217

C Mill Virtual Reality Applied Rehabilitation and Classical Rehabilitation on Gait and Balance in Parkinson's Patients

In this research; the investigators would like to compare the results of patients with Parkinson's disease in the two groups who received classical physical therapy and rehabilitation program and virtual reality assisted walking and balance exercise at the beginning (1st rehabilitation day =1. day) and end of rehabilitation (21st rehabilitation day=50.day). In addition, the investigators aimed to reveal the change of gait and balance parameters by measuring the C-mill walking and balance rehabilitation device with numerical data and graphic analysis.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Rehabilitation Synucleinopathies

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Romatem Romatem Physical Therapy and Rehabilitation Hospitals Bursa Hospitals Bursa Hospital

Bursa, 16030, Turkey (Türkiye)

About this study

BASIS AND JUSTIFICATION OF THE RESEARCH: : In Parkinson's patients, difficulty in walking, slowing down in movements, difficulties in starting and maintaining walking become evident in Hoehn Yahr stage 2-3-4 stages of the disease. In addition to drug therapy, physical therapy and rehabilitation applications have proven to be effective in conditions such as walking and movement restriction in Parkinson's patients. Rehabilitation with a physiotherapist, controlled home exercise programs, and robot-assisted rehabilitation practices were all found to be effective in the clinic.

EXPECTED BENEFITS AFTER THE RESEARCH: It improves the patient's daily life activities and tests of all kinds of FTR applications. With the rehabilitation the investigators will implement, the investigators will help patients to be able to walk, sit and stand up unaided and independently. The investigators expect an increase in exercise capacity, an increase in walking distance, an improvement in balance and walking, and an increase in balance and walking measurements.

RESEARCH METHOD:

  • All measurements 1st day when rehabilitation applications started and 50th day when rehabilitation applications end.
  • To evaluate whether they benefit from the applied rehabilitation; Changes in the patient's own values will be compared on the first day and the last day of rehabilitation.
  • It will be determined whether there is a difference between the scales and values between the two groups in which classical rehabilitation and C mill virtual reality applied rehabilitation.
  • In order to determine the neurological examination status of the patients:

UPDR s-III: Unified Parkinson's Disease Rating Scale-Motor: maximum 56 points and a high score is considered bad.

Regarding balance and walking: Tinetti test: the maximum possible score is 28, a high score is considered good.

To measure the time it takes to get up and walk 3 meters from the seat, turn and sit in the chair that he/she started again: The time up and go test: normal value: It was determined as less than 12 seconds.

To determine their own thoughts about the quality of life and the health of the patient: Short Form Health Survey-36: Norm values for the Turkish society have been determined, and the values received by the patients will be interpreted accordingly.

To determine the ability to walk: Functional Ambulation Classification (FAC): A value between 0 and 5. A high score is determined as good.

  • Walking parameters:Measurements will be made with a C mill walking and balance rehabilitation device.

It is known that walking speed, walking distance, walking time, step length, and number of steps per minute decrease in Parkinson's patients. In order to measure whether there is an increase or change in these values with rehabilitation: Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes: Single stance phase (%), Single stance time (s), weight transfer %, right and left stride length (cm), two stride length (cm), symmetry ( %), walking distance (m), walking time (minute), walking speed (km/h), total number of steps and number of steps per minute.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inclusion criteria:
  • Women and men
  • 60-80 years old Those who have been diagnosed with Parkinson's disease and are using regular drug therapy
  • Hoehn Yahr Stage: 2-3-4

Hoehn-Yahr Staging:

Stage 0- No signs of disease. Stage 1- Unilateral disease. Stage 1.5- Unilateral plus axial involvement. Stage 2- Bilateral disease, no balance disorder. Stage 2.5- Mild bilateral disease recovering in the pull test. Stage 3 - Mild to moderate bilateral disease and some postural instability, physically independent.

Stage 4 - Severe disability, able to stand and walk unaided. Stage 5 - unassisted wheelchair or bed dependent. Can be mobilized without support or with minimal support

Exclusion criteria

Criteria for exclusion of volunteers from the study:

  • psychiatric illness, dementia
  • advanced vision and hearing problems
  • diseases that limit walking and movement: joint disease (knee, hip joint diseases), advanced spinal stenosis, lumbar discopathy, hemiplegia
  • heart failure and respiratory failure

Treatment and study plan

classical physical therapy with physiotherapy.

Procedure

C-Mill device: It is possible to stand and walk on the treadmill. The patient is fixed to the moving band by attaching a garment made of corset-like straps, and thanks to this system, the risk of falling of the patient is prevented. There are virtual reality applications on the treadmill floor and on the giant screen opposite: ball collection It provides adaptation of walking to normal life with animal figures, forest or street images, sounds. In classical physical therapy, muscle strengthening, sitting, standing and walking exercises will be performed with physiotherapy.

Other names: C mill virtual reality applied rehabilitation

Primary outcomes

  1. UPDR s-III: Unified Parkinson's Disease Rating Scale-Motor

    Time frame: 1st day: when rehabilitation applications started

    In order to determine the neurological examination status of the patients: UPDR s-III: Unified Parkinson's Disease Rating Scale-Motor: maximum 56 points and a high score is considered bad

  2. UPDR s-III: Unified Parkinson's Disease Rating Scale-Motor

    Time frame: 50th day: when rehabilitation applications end

    In order to determine the neurological examination status of the patients: UPDR s-III: Unified Parkinson's Disease Rating Scale-Motor: maximum 56 points and a high score is considered bad

  3. Tinetti test

    Time frame: 1st day: when rehabilitation applications started

    Regarding balance and walking: Tinetti test: the maximum possible score is 28, a high score is considered good.

  4. Tinetti test

    Time frame: 50th day: when rehabilitation applications end

    Regarding balance and walking: Tinetti test: the maximum possible score is 28, a high score is considered good.

  5. The time up and go test

    Time frame: 1st day: when rehabilitation applications started

    To measure the time it takes to get up and walk 3 meters from the seat, turn and sit in the chair that he/she started again: The time up and go test: normal value: It was determined as less than 12 seconds.

  6. The time up and go test

    Time frame: 50th day: when rehabilitation applications end

    To measure the time it takes to get up and walk 3 meters from the seat, turn and sit in the chair that he/she started again: The time up and go test: normal value: It was determined as less than 12 seconds.

  7. Short Form Health Survey-36

    Time frame: 1st day: when rehabilitation applications started

    To determine their own thoughts about the quality of life and the health of the patient: Short Form Health Survey-36: Norm values for the Turkish society have been determined, and the values received by the patients will be interpreted accordingly.

  8. Short Form Health Survey-36

    Time frame: 50th day: when rehabilitation applications end

    To determine their own thoughts about the quality of life and the health of the patient: Short Form Health Survey-36: Norm values for the Turkish society have been determined, and the values received by the patients will be interpreted accordingly.

  9. Functional Ambulation Classification (FAC)

    Time frame: 1st day: when rehabilitation applications started

    To determine the ability to walk: Functional Ambulation Classification (FAC): A value between 0 and 5. A high score is determined as good.

  10. Functional Ambulation Classification (FAC)

    Time frame: 50th day: when rehabilitation applications end

    To determine the ability to walk: Functional Ambulation Classification (FAC): A value between 0 and 5. A high score is determined as good.

  11. Single stance phase (%)

    Time frame: 1st day: when rehabilitation applications started

    Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes

  12. Single stance phase (%)

    Time frame: 50th day:when rehabilitation applications end

    Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes

  13. single stance time (s)

    Time frame: 1st day: when rehabilitation applications started d

    Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes

  14. single stance time (s)

    Time frame: 50th day: when rehabilitation applications end

    Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes

  15. two stride length (cm)

    Time frame: 1st day: when rehabilitation applications started

    Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes

  16. two stride length (cm)

    Time frame: 50th day :when rehabilitation applications end

    Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes

  17. right stride length (cm)

    Time frame: 1st day: when rehabilitation applications started

    Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes

  18. right stride length (cm),

    Time frame: 50th day: when rehabilitation applications end

    Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes

  19. left stride length (cm)

    Time frame: 1st day: when rehabilitation applications started

    Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes

  20. left stride length (cm)

    Time frame: 50th day: when rehabilitation applications end

    Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes

  21. walking distance (m)

    Time frame: 1st day: when rehabilitation applications started

    Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes

  22. walking distance (m)

    Time frame: 50th day: when rehabilitation applications end

    Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes

  23. walking time (minute)

    Time frame: 1st day: when rehabilitation applications started

    Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes

  24. walking time (minute)

    Time frame: 50th day: when rehabilitation applications end

    Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes

  25. walking speed (km/h)

    Time frame: 1st day: when rehabilitation applications started

    Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes

  26. walking speed (km/h)

    Time frame: 50th day: when rehabilitation applications end

    Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes

  27. step symmetry ( %)

    Time frame: 1st day: when rehabilitation applications started

    Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes

  28. step symmetry ( %)

    Time frame: 50th day: when rehabilitation applications end

    Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes

  29. number of steps per minute.

    Time frame: 1st day: when rehabilitation applications started

    Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes

  30. number of steps per minute.

    Time frame: 50th day: when rehabilitation applications end

    Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes

Sponsors and collaborators

Lead sponsor

Romatem Bursa Hospital

Other

Collaborators

  • Bursa City Hospital

Registry information

Official study title

The Effects of C Mill Virtual Reality Applied Rehabilitation and Classical Rehabilitation on Gait and Balance in Parkinson's Patients: Randomized Controlled Study

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 27, 2023
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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