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

Sponsor
Romatem Bursa Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05703217
Collaborator
Bursa City Hospital (Other)
20
1
2
12
1.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: classical physical therapy with physiotherapy.
N/A

Detailed Description

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:
  1. All measurements 1st day when rehabilitation applications started and 50th day when rehabilitation applications end.

  2. 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.

  3. 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.

  4. 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.

  1. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled studyRandomized controlled study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effects of C Mill Virtual Reality Applied Rehabilitation and Classical Rehabilitation on Gait and Balance in Parkinson's Patients: Randomized Controlled Study
Actual Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: classical physical therapy and rehabilitation program

In classical physical therapy, muscle strengthening, sitting, standing and walking exercises will be performed with physiotherapy.

Procedure: classical physical therapy with physiotherapy.
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
  • Active Comparator: virtual reality assisted walking and balance exercise program

    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.

    Procedure: classical physical therapy with physiotherapy.
    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
  • Outcome Measures

    Primary Outcome Measures

    1. UPDR s-III: Unified Parkinson's Disease Rating Scale-Motor [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 [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 [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 [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 [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 [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 [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 [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) [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) [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 (%) [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 (%) [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) [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) [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) [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) [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) [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), [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) [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) [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) [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) [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) [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) [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) [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) [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 ( %) [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 ( %) [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. [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. [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Romatem Romatem Physical Therapy and Rehabilitation Hospitals Bursa Hospitals Bursa Hospital Bursa Turkey 16030

    Sponsors and Collaborators

    • Romatem Bursa Hospital
    • Bursa City Hospital

    Investigators

    • Study Director: NERMİN ÇALIŞIR, ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL
    • Principal Investigator: NURTEN KÜÇÜKÇAKIR, ROMATEM ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITALS BURSA HOSPITAL
    • Principal Investigator: SİNEM AKSELİM, BURSA CİTY HOSPİTAL PHYSICAL THERAPY AND REHABILITATION HOSPITAL
    • Principal Investigator: Muhammed Ali DEMİRBAĞ, ROMATEM ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITALS BURSA HOSPITAL
    • Principal Investigator: RAFET AKAR, ROMATEM ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITALS BURSA HOSPITAL
    • Principal Investigator: ŞEYDA ÖNCÜL, ROMATEM ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITALS BURSA HOSPITAL
    • Principal Investigator: GÖKHAN KAYA, ROMATEM ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITALS BURSA HOSPITAL
    • Principal Investigator: ANIL YILMAZ, ROMATEM ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITALS BURSA HOSPITAL

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nermin Çalışır, Principal İnvestigator,Head of Neurology, Romatem Bursa Hospital
    ClinicalTrials.gov Identifier:
    NCT05703217
    Other Study ID Numbers:
    • 2022-4/1
    First Posted:
    Jan 27, 2023
    Last Update Posted:
    Jan 27, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Nermin Çalışır, Principal İnvestigator,Head of Neurology, Romatem Bursa Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 27, 2023