The Effect of Hybrid Telerehabilitation-Based Structured Exercise Programs in Patients With Multiple Sclerosis

December 18, 2024 updated by: Guzin Kaya Aytutuldu, Biruni University

The Effect of Hybrid Telerehabilitation-Based Structured Exercise Programs on Gait, Functional Capacity, EMG Muscle Activation and Fatigue in Patients With Multiple Sclerosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İstanbul, Turkey
        • Biruni University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Telerehabilitation Group
An eight-week rehabilitation program will be implemented synchronously with the physiotherapist two days a week via video conferencing system.
Other: Exercise Program
Structured rehabilitation program of the groups; Patient education consists of aerobic and strengthening exercises. An information brochure will be given to patients after the first evaluation about the program to be implemented.
Experimental: Hybrid Telerehabilitation Group
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.
Other: Exercise Program
Structured rehabilitation program of the groups; Patient education consists of aerobic and strengthening exercises. An information brochure will be given to patients after the first evaluation about the program to be implemented.
Active Comparator: Clinic Group
An eight-week rehabilitation program will be implemented face to face in the clinic.
Other: Exercise Program
Structured rehabilitation program of the groups; Patient education consists of aerobic and strengthening exercises. An information brochure will be given to patients after the first evaluation about the program to be implemented.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait Speed
Time Frame: 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
5 minutes
Functional Capacity
Time Frame: 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.
6 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Fatigue Impact Scale
Time Frame: 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
5 minutes
EMG muscle activation for work and rest average
Time Frame: 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.
5 minutes
EMG muscle activation for peak torque
Time Frame: 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.
5 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Rating of Change Scale
Time Frame: 1minutes
Evaluation of Patient Satisfaction: Patient satisfaction will be evaluated with the Global Change Scale. Participants will be asked to express the difference in improvement in their health after treatment compared to before treatment.
1minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biruni University

Investigators

  • Principal Investigator: Guzin Kaya Aytutuldu, Biruni University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2023

Primary Completion (Actual)

February 12, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

February 16, 2024

First Submitted That Met QC Criteria

March 1, 2024

First Posted (Actual)

March 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 18, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BiruniUnive
  • Researcher (Other Identifier: Bahçeşehir University)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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