The Effect of Hybrid Telerehabilitation-Based Structured Exercise Programs in Patients With Multiple Sclerosis
- Conditions
- Multiple Sclerosis
- Interventions
- Other: Exercise Program
- Registration Number
- NCT06293079
- Lead Sponsor
- Biruni University
- Brief Summary
The aim of our study is to compare the effects of hybrid telerehabilitation (TR)-based exercise program applied in patients with MS, only TR-based exercise program and only clinical-based exercise program on walking speed, functional capacity, peripheral muscle saturation and fatigue. Forty-five individuals with MS with EDSS scores between 0-4 will be included in the study. The patients will be randomized into three groups: Group A, Group B, and Group C. Group A- Telerehabilitation group will be included in an aerobic and strengthening exercise program over the synchronized videoconference system with the physiotherapist 2 days a week for 8 weeks. Group B- Hybrid Telerehabilitation group will be included in the same exercise program 2 days a week for 2 weeks in the clinic, and will continue remotely over the synchronized videoconference system with the physiotherapist 2 days a week for 6 weeks. In Group C-Clinical Based Rehabilitation group, the same exercise program will be applied in the clinic 2 days a week for 8 weeks. In addition to aerobic and strengthening exercises, traditional breathing exercises and energy conservation techniques will be taught to all three groups within the scope of patient education Demographic and clinical information of all patients to be included in the study will be recorded with a "Case Evaluation Form". The gait speed of the patients will be evaluated with the Timed 25-step walking test, their functional capacity with the 6-minute walking test, their Quadriceps muscle activation will be tested with the EMG muscle activation, the fatigue will be evaluated with the "Modified Fatigue Impact Scale", and the Patient Satisfaction with the "Global Rating Scale". In addition, feasibility evaluation will be made by calculating the attendance rate of the patients to the programs. All data will be evaluated by statistical analysis methods.
- Detailed Description
Multiple Sclerosis (MS) is a chronic progressive disease that often leads to deterioration of health-related quality of life, including symptoms such as muscle weakness, extreme fatigue, gait disturbances, sensory problems, balance problems, and chronic pain, cognitive and motor impairments. Physiotherapy and rehabilitation programs that include aerobic and progressive resistance exercises in the treatment of functional disorders by controlling the symptoms of the disease increase the quality of life by improving aerobic capacity, but sustainability can be difficult due to difficulties in accessing the clinic. Following exercise programs with telerehabilitation (TR) methods improves cognitive function, mobility, balance, participation, and quality of life by increasing physical activity and reducing fatigue. However, the details of the frequency, duration, and the way the program is delivered are not known, and although the exercise methods applied with TR methods are found to be as effective as the practices performed in the clinic, the remote limited patient-therapist relationship creates potential problems for patients to follow up on the digital platform. The hybrid TR model, in which a certain part of the exercise program is carried out face-to-face, can provide a solution to these problems by increasing patient-therapist communication. To the best of our knowledge, there is no study examining the effectiveness of a rehabilitation program applied with the hybrid TR model for individuals with MS. The aim of our study is to compare the effects of hybrid telerehabilitation (TR)-based exercise program applied in patients with MS, only TR-based exercise program and only clinical-based exercise program on walking speed, functional capacity, peripheral muscle saturation and fatigue. Forty-five individuals with MS with EDSS scores between 0-4 will be included in the study. The patients will be randomized into three groups: Group A, Group B, and Group C. Group A- Telerehabilitation group will be included in an aerobic and strengthening exercise program over the synchronized videoconference system with the physiotherapist 2 days a week for 8 weeks. Group B- Hybrid Telerehabilitation group will be included in the same exercise program 2 days a week for 2 weeks in the clinic, and will continue remotely over the synchronized videoconference system with the physiotherapist 2 days a week for 6 weeks. In Group C-Clinical Based Rehabilitation group, the same exercise program will be applied in the clinic 2 days a week for 8 weeks. In addition to aerobic and strengthening exercises, traditional breathing exercises and energy conservation techniques will be taught to all three groups within the scope of patient education Demographic and clinical information of all patients to be included in the study will be recorded with a "Case Evaluation Form". The gait speed of the patients will be evaluated with the Timed 25-step walking test, their functional capacity with the 6-minute walking test, their Quadriceps muscle activation will be tested with the EMG muscle activation, the fatigue will be evaluated with the "Modified Fatigue Impact Scale", and the Patient Satisfaction with the "Global Rating Scale". In addition, feasibility evaluation will be made by calculating the attendance rate of the patients to the programs. All data will be evaluated by statistical analysis methods. The aim of this study is to investigate the effect of hybrid telerehabilitation program on walking speed, functional capacity, peripheral muscle activation and fatigue in patients with MS.
For these purposes:
* To increase compliance and participation of MS patients in exercises,
* To prevent fatigue by increasing the functional capacity of MS patients who regularly participate in exercise programs,
* To provide a sustainable program for exercise continuity for MS patients who have difficulty reaching the clinic and to examine its effects on fatigue,
* To compare the effects of Telerehabilitation, Hybrid Telerehabilitation and the same exercise programs performed in the clinic on gait speed, functional capacity, peripheral muscle activation and fatigue,
* To examine the statistical differences and relationships between the expected improvements in functional capacity, peripheral muscle activation and fatigue parameters,
* To offer an innovative and effective treatment option to clinicians and experts working in the relevant field with the hybrid telerehabilitation model, which can be an alternative to traditional methods,
* It is aimed to contribute to the literature in this field by transforming the results obtained because of the study into qualified scientific publications.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- EDSS score of 0 - 4.0
- Having high-speed internet access via smartphone or computer
- Getting at least 24 points from the Mini Mental Test
- Being at Stage 3 or above according to the Functional Ambulation Scale.
- Having hearing or vision problems.
- Participating in any exercise program.
- Having other accompanying neurological, cardiovascular or orthopedic disorders
- A history of MS attacks or a change in medication in the last 6 months.
- Being in a physical condition that cannot do the exercises.
- Comorbid conditions that negatively affect oxygen transport (severe anemia, peripheral artery diseases, etc.)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telerehabilitation Group Exercise Program An eight-week rehabilitation program will be implemented synchronously with the physiotherapist two days a week via video conferencing system. Clinic Group Exercise Program An eight-week rehabilitation program will be implemented face to face in the clinic. Hybrid Telerehabilitation Group Exercise Program The first two weeks of the eight-week program will be applied face to face in the clinic, and the six weeks will be applied synchronously with the physiotherapist via video conferencing system.
- Primary Outcome Measures
Name Time Method Gait Speed 5 minutes The primary evaluation criterion is walking speed. The timed 25-step walking test will be used to evaluate walking speed. In T25FW, which evaluates lower extremity function, patients are asked to walk a distance of 7.62 m as quickly as possible, but without running and safely, and the completion time is recorded in seconds. The average of the two trials is recorded as the T25FW score. T25FW is the best-defined measurement method for measuring gait impairment in individuals with MS and for evaluating the walking speed of patients with gait impairment in the clinical setting
Functional Capacity 6 minutes Functional capacity will be evaluated with a six-minute walk test. The six-minute walk test is a frequently used test that evaluates physical function and walking capacity in patients with MS. According to the principles of the American Thoracic Society, the 6-minute walk test should be performed in the clinic in a 30-meter, flat and hard corridor. The distance walked by the patient is calculated. Patients may stop or slow down if they feel dyspnea. These and similar explanations should be made to the patients. The Borg Dyspnea Scale level, saturation, pulse and blood pressure values should be recorded at the beginning and end of the test.
- Secondary Outcome Measures
Name Time Method EMG muscle activation for work and rest average 5 minutes Rectus Femoris and Vastus lateralis muscle activation will be tested with surface EMG device(Myoplus 2 pro)
During activation and relaxation of muscle; work average time, during rest; rest average time , average release time will be recorded.EMG muscle activation for peak torque 5 minutes Rectus Femoris and Vastus lateralis muscle activation will be tested with surface EMG device(Myoplus 2 pro)
During activation and relaxation of muscle; peak torque will be recorded.Modified Fatigue Impact Scale 5 minutes It is a fatigue scale frequently used in clinical and experimental studies. It evaluates the physical, cognitive and social effects of fatigue. It consists of a total of 21 questions. Each item is given a score between 0 and 4, and a low score indicates a low degree of fatigue. A Turkish validity and reliability study of the this scale has been conducted, and it will be used to determine the fatigue effect in our study
Trial Locations
- Locations (1)
Biruni University
🇹🇷İstanbul, Turkey