The Effects of Respiratory-based Telerehabilitaion in Patients With MS

Sponsor
Dr. Anıl Tosun (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04887051
Collaborator
Trakya University (Other)
100
1
1
4.5
22.4

Study Details

Study Description

Brief Summary

During the pandemic, it is important for people who are isolated in their homes to stay inactive and exercise exercises in order to prevent their complaints from increasing due to inactivity. Individuals with multiple sclerosis are outpatient or inpatient with home exercise programs besides the rehabilitation practices. They are being monitored. It has been reported the rehabilitation of individuals is that they need to comply with their home exercise programs in order to contribute. However, very limited research studies suggest that any method can be used as home exercise has examined whether it has increased compliance with the program. However, examining the factors affecting the compliance of individuals with Multiple sclerosis to the home exercise program. The study was not found either.

Exercise through tele-rehabilitation in individuals with multiple sclerosis in previous studies where their education contributed to the physical performance of patients shown. However, these studies are based on individual neurorehabilitation models. In the literature, the use of video-based exercise training in MS patients a study showing increased performance as well as increased participation in the home program available. However, in this study, a special program was applied to the individual and it is not a respiration-based program. There is no research on web-based group activity training in the field.

Condition or Disease Intervention/Treatment Phase
  • Other: pulmonory based home exercises
N/A

Detailed Description

Multiple sclerosis is chronic and improves the quality of life of the person is a neurological disease that decreases. Multiple Sclerosis in mobility and functional activities cause restrictions in social and professional life, leading to different degrees of disability. It is a disease that causes severe disability and impairs the quality of life. MS, It is one of the most common diseases that cause disability, usually between the ages of 15-50. In recent years, combating disability caused by MS is the most important and has been the main focus. Patients' life expectancy is gradually increasing, One of the important reasons for this is symptomatic treatments and modern rehabilitation. It is said to have applications.

Depression affects approximately 50% of patients with MS. The social isolation caused by quarantine may have increased depression. In MS, in combating spasticity, as well as depression and chronic fatigue, regular exercise is important.

During the pandemic, it is important for people who are isolated in their homes to stay inactive and exercise exercises in order to prevent their complaints from increasing due to inactivity. Individuals with multiple sclerosis are outpatient or inpatient with home exercise programs besides the rehabilitation practices. They are being monitored. It has been reported the rehabilitation of individuals is that they need to comply with their home exercise programs in order to contribute. However, very limited research studies suggest that any method can be used as home exercise has examined whether it has increased compliance with the program. However, examining the factors affecting the compliance of individuals with Multiple sclerosis to the home exercise program. The study was not found either.

Exercise through tele-rehabilitation in individuals with multiple sclerosis in previous studies where their education contributed to the physical performance of patients shown. However, these studies are based on individual neurorehabilitation models. In the literature, the use of video-based exercise training in MS patients a study showing increased performance as well as increased participation in the home program available. However, in this study, a special program was applied to the individual and it is not a respiration-based program. There is no research on web-based group activity training in the field.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effects of Respiratory-based Telerehabilitation on Physical Performance and Factors Affecting Compliance in Patients With Multiple Sclerosis
Actual Study Start Date :
Apr 16, 2021
Anticipated Primary Completion Date :
Jun 30, 2021
Anticipated Study Completion Date :
Aug 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: telerehabilitation

pre-post telerehabilltation

Other: pulmonory based home exercises
web based telerehablitation
Other Names:
  • telerehabilitation
  • Outcome Measures

    Primary Outcome Measures

    1. Barthell Scale [1st assesment: At first day (baseline avaluation); 2nd assesment: Change from baseline BI score at 1 month after the program start. 3rd assesment: Change from baseline BI score at 2 month after the program start]

      The Barthel Scale/Index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL). Ten variables describing ADL and mobility are scored, a higher number being a reflection of greater ability to function independently following hospital discharge.Time taken and physical assistance required to perform each item are used in determining the assigned value of each item. Time to administer- Self report: 2-5 minutes; Direct observation: 20 minutes. Each item is rated in terms of whether the patient can perform the task independently, with some assistance, or is dependent on help based on observation (0=unable, 1=needs help, 2=independent). The final score is x 5 to get a number on a 100 point score. Barthel scores are that scores of 0-20 indicate "total" dependency and 91-99 indicates "slight" dependency.

    2. Functional Ambulatation Categories [1st assesment: At first day (baseline avaluation); 2nd assesment: Change from baseline FAC score at 1 month after the program start. 3rd assesment: Change from baseline FAC score at 2 month after the program start.]

      The Functional Ambulation Categories (FAC) is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device. Functional Ambulation Classification (FAS): FAS is a valid and reliable scale that evaluates the physical support needed during walking over 6 scores between 0 and 5. It is scored according to the support needed by the patient through observation. Accordingly, the scores; 0- It cannot be ambulatory alone, except for the parallel bar, the patient needs the help of at least 2 people in order to be ambulatory. 5- It walks independently on all floors.

    3. Fatigue Severity Scale [1st assesment: At first day (baseline avaluation); 2nd assesment: Change from baseline FSS score at 1 month after the program start. 3rd assesment: Change from baseline FSS score at 2 month after the program start]

      The Fatigue Severity Scale (FSS) is designed to differentiate fatigue from clinical depression, since both share some of the same symptoms. Essentially, the FSS consists of answering a short questionaire that requires the subject to rate his or her own level of fatigue. The obvious problem with this measure is its subjectivity.A self-report scale of nine items about fatigue, its severity and how it affects certain activities. Answers are scored on a seven point scale where 1 = strongly disagree and 7 = strongly agree. This means the minimum score possible is nine and the highest is 63. The higher the score, the more severe the fatigue is and the more it affects the person's activities. It is simple to understand and takes an average of eight minutes to answer.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria: ambulatuar or non -ambulatuar

    • All patients with diagnosed with Multiple Sclerosis. (Diagnosis of MS according to the revised McDonald Criteria 2017)

    • An ability to understand and execute simple instructions.

    • Aged 20-65 years old.

    Exclusion Criteria:
    • patients with hearing, vision and cognitive problems.

    • Pregnancy (self-reported)

    • Orthopedic and other neurological disorders affecting upper limb movements (e.g., epileptic seizures)

    • Contra-indication to physical activity (e.g., heart failure, severe osteoporosis) MS clinical relapse or treatment with corticosteroid therapy within 30 days prior to enrollment

    • Started or stopped a disease-modifying therapy for MS within 30 days prior to enrollment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fenerbahce University Istanbul Turkey 34758

    Sponsors and Collaborators

    • Dr. Anıl Tosun
    • Trakya University

    Investigators

    • Study Chair: Anıl Tosun, Dr., Fenerbahce University
    • Study Director: Hilal Keklicek, Asc.Prof., Trakya University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Anıl Tosun, Assistant professor, Fenerbahce University
    ClinicalTrials.gov Identifier:
    NCT04887051
    Other Study ID Numbers:
    • Fenerbahçe Üniversitesi
    First Posted:
    May 14, 2021
    Last Update Posted:
    May 14, 2021
    Last Verified:
    May 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dr. Anıl Tosun, Assistant professor, Fenerbahce University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 14, 2021