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

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05703217
• Other study ID #: 2022-4/1
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: November 2023
• Source: Romatem Bursa Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: June 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Rehabilitation

Intervention

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.

Locations

Country	Name	City	State
Turkey	Romatem Romatem Physical Therapy and Rehabilitation Hospitals Bursa Hospitals Bursa Hospital	Bursa

Sponsors (2)

Lead Sponsor	Collaborator
Romatem Bursa Hospital	Bursa City Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	UPDR s-III: Unified Parkinson's Disease Rating Scale-Motor	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	1st day: when rehabilitation applications started
Primary	UPDR s-III: Unified Parkinson's Disease Rating Scale-Motor	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	50th day: when rehabilitation applications end
Primary	Tinetti test	Regarding balance and walking: Tinetti test: the maximum possible score is 28, a high score is considered good.	1st day: when rehabilitation applications started
Primary	Tinetti test	Regarding balance and walking: Tinetti test: the maximum possible score is 28, a high score is considered good.	50th day: when rehabilitation applications end
Primary	The time up and go test	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.	1st day: when rehabilitation applications started
Primary	The time up and go test	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.	50th day: when rehabilitation applications end
Primary	Short Form Health Survey-36	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.	1st day: when rehabilitation applications started
Primary	Short Form Health Survey-36	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.	50th day: when rehabilitation applications end
Primary	Functional Ambulation Classification (FAC)	To determine the ability to walk: Functional Ambulation Classification (FAC): A value between 0 and 5. A high score is determined as good.	1st day: when rehabilitation applications started
Primary	Functional Ambulation Classification (FAC)	To determine the ability to walk: Functional Ambulation Classification (FAC): A value between 0 and 5. A high score is determined as good.	50th day: when rehabilitation applications end
Primary	Single stance phase (%)	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	1st day: when rehabilitation applications started
Primary	Single stance phase (%)	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	50th day:when rehabilitation applications end
Primary	single stance time (s)	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	1st day: when rehabilitation applications started d
Primary	single stance time (s)	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	50th day: when rehabilitation applications end
Primary	two stride length (cm)	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	1st day: when rehabilitation applications started
Primary	two stride length (cm)	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	50th day :when rehabilitation applications end
Primary	right stride length (cm)	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	1st day: when rehabilitation applications started
Primary	right stride length (cm),	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	50th day: when rehabilitation applications end
Primary	left stride length (cm)	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	1st day: when rehabilitation applications started
Primary	left stride length (cm)	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	50th day: when rehabilitation applications end
Primary	walking distance (m)	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	1st day: when rehabilitation applications started
Primary	walking distance (m)	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	50th day: when rehabilitation applications end
Primary	walking time (minute)	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	1st day: when rehabilitation applications started
Primary	walking time (minute)	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	50th day: when rehabilitation applications end
Primary	walking speed (km/h)	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	1st day: when rehabilitation applications started
Primary	walking speed (km/h)	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	50th day: when rehabilitation applications end
Primary	step symmetry ( %)	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	1st day: when rehabilitation applications started
Primary	step symmetry ( %)	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	50th day: when rehabilitation applications end
Primary	number of steps per minute.	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	1st day: when rehabilitation applications started
Primary	number of steps per minute.	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	50th day: when rehabilitation applications end