Clinical trial NCT05703217: C Mill Virtual Reality Applied Rehabilitation and Classical Rehabilitation on Gait and Balance in Parkinson's Patients
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Parkinson Disease
Rehabilitation
Keywords: Parkinson Disease
Rehabilitation
Gait
Balance
Lead sponsor: Romatem Bursa Hospital
Sponsor class: OTHER
Collaborators: name: Bursa City Hospital
First posted: 2023-01-27
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled study
Primary purpose: TREATMENT

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.

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.
5. 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.

Eligibility criteria: 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

Primary outcomes:
measure: UPDR s-III: Unified Parkinson's Disease Rating Scale-Motor
timeFrame: 1st day: when rehabilitation applications started
measure: UPDR s-III: Unified Parkinson's Disease Rating Scale-Motor
timeFrame: 50th day: when rehabilitation applications end
measure: Tinetti test
timeFrame: 1st day: when rehabilitation applications started
measure: Tinetti test
timeFrame: 50th day: when rehabilitation applications end
measure: The time up and go test
timeFrame: 1st day: when rehabilitation applications started
measure: The time up and go test
timeFrame: 50th day: when rehabilitation applications end
measure: Short Form Health Survey-36
timeFrame: 1st day: when rehabilitation applications started
measure: Short Form Health Survey-36
timeFrame: 50th day: when rehabilitation applications end
measure: Functional Ambulation Classification (FAC)
timeFrame: 1st day: when rehabilitation applications started
measure: Functional Ambulation Classification (FAC)
timeFrame: 50th day: when rehabilitation applications end
measure: Single stance phase (%)
timeFrame: 1st day: when rehabilitation applications started
measure: Single stance phase (%)
timeFrame: 50th day:when rehabilitation applications end
measure: single stance time (s)
timeFrame: 1st day: when rehabilitation applications started d
measure: single stance time (s)
timeFrame: 50th day: when rehabilitation applications end
measure: two stride length (cm)
timeFrame: 1st day: when rehabilitation applications started
measure: two stride length (cm)
timeFrame: 50th day :when rehabilitation applications end
measure: right stride length (cm)
timeFrame: 1st day: when rehabilitation applications started
measure: right stride length (cm),
timeFrame: 50th day: when rehabilitation applications end
measure: left stride length (cm)
timeFrame: 1st day: when rehabilitation applications started
measure: left stride length (cm)
timeFrame: 50th day: when rehabilitation applications end
measure: walking distance (m)
timeFrame: 1st day: when rehabilitation applications started
measure: walking distance (m)
timeFrame: 50th day: when rehabilitation applications end
measure: walking time (minute)
timeFrame: 1st day: when rehabilitation applications started
measure: walking time (minute)
timeFrame: 50th day: when rehabilitation applications end
measure: walking speed (km/h)
timeFrame: 1st day: when rehabilitation applications started
measure: walking speed (km/h)
timeFrame: 50th day: when rehabilitation applications end
measure: step symmetry ( %)
timeFrame: 1st day: when rehabilitation applications started
measure: step symmetry ( %)
timeFrame: 50th day: when rehabilitation applications end
measure: number of steps per minute.
timeFrame: 1st day: when rehabilitation applications started
measure: number of steps per minute.
timeFrame: 50th day: when rehabilitation applications end
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Romatem Romatem Physical Therapy and Rehabilitation Hospitals Bursa Hospitals Bursa Hospital
Study officials:
affiliation: ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL
name: NERMİN ÇALIŞIR
role: STUDY_DIRECTOR
affiliation: ROMATEM ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITALS BURSA HOSPITAL
name: NURTEN KÜÇÜKÇAKIR
role: PRINCIPAL_INVESTIGATOR
affiliation: BURSA CİTY HOSPİTAL PHYSICAL THERAPY AND REHABILITATION HOSPITAL
name: SİNEM AKSELİM
role: PRINCIPAL_INVESTIGATOR
affiliation: ROMATEM ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITALS BURSA HOSPITAL
name: Muhammed Ali DEMİRBAĞ
role: PRINCIPAL_INVESTIGATOR
affiliation: ROMATEM ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITALS BURSA HOSPITAL
name: RAFET AKAR
role: PRINCIPAL_INVESTIGATOR
affiliation: ROMATEM ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITALS BURSA HOSPITAL
name: ŞEYDA ÖNCÜL
role: PRINCIPAL_INVESTIGATOR
affiliation: ROMATEM ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITALS BURSA HOSPITAL
name: GÖKHAN KAYA
role: PRINCIPAL_INVESTIGATOR
affiliation: ROMATEM ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITALS BURSA HOSPITAL
name: ANIL YILMAZ
role: PRINCIPAL_INVESTIGATOR
References: