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

Romatem Bursa Hospital1 个研究点分布在 1 个国家目标入组 20 人2022年6月1日

适应症Parkinson Disease Rehabilitation

干预措施classical physical therapy with physiotherapy.

概览

阶段: 不适用
干预措施: classical physical therapy with physiotherapy.
疾病 / 适应症: Parkinson Disease
发起方: Romatem Bursa Hospital
入组人数: 20
试验地点: 1
主要终点: Tinetti test
状态: 已完成
最后更新: 3个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

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.

详细描述

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.

注册库

clinicaltrials.gov

开始日期

2022年6月1日

结束日期

2024年6月1日

最后更新

3个月前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Romatem Bursa Hospital

责任方

Principal Investigator

主要研究者

Nermin Çalışır

Principal İnvestigator,Head of Neurology

Romatem Bursa Hospital

入排标准

入选标准

•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

排除标准

•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

研究组 & 干预措施

classical physical therapy and rehabilitation program

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

干预措施: classical physical therapy with physiotherapy.

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.

干预措施: classical physical therapy with physiotherapy.