Clinical trial NCT06293079: The Effect of Hybrid Telerehabilitation-Based Structured Exercise Programs in Patients With Multiple Sclerosis
Official title: The Effect of Hybrid Telerehabilitation-Based Structured Exercise Programs on Gait, Functional Capacity, EMG Muscle Activation and Fatigue in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: telerehabilitation
exercise therapy
MS patients
Lead sponsor: Biruni University
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.)

Primary outcomes:
measure: Gait Speed
timeFrame: 5 minutes
measure: Functional Capacity
timeFrame: 6 minutes
Secondary outcomes:
measure: EMG muscle activation for work and rest average
timeFrame: 5 minutes
measure: EMG muscle activation for peak torque
timeFrame: 5 minutes
measure: Modified Fatigue Impact Scale
timeFrame: 5 minutes
Other outcomes:
measure: Global Rating of Change Scale
timeFrame: 1minutes
Locations:
city: İstanbul
country: Turkey
facility: Biruni University
Study officials:
affiliation: Biruni University
name: Guzin Kaya Aytutuldu
role: PRINCIPAL_INVESTIGATOR
References:
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