The Effects of Respiratory-based Telerehabilitaion in Patients With MS

NCT04887051 | Unknown DMC

• 1 other identifier: Fenerbahçe Üniversitesi
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Telerehabilitation; Compliance, Patient

Keywords

Telerehabilitation, Multiple Sclerosis

Outcome Measures

Primary Outcomes (3)

• Barthell Scale

  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.

  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

• Functional Ambulatation Categories

  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.

  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.

• Fatigue Severity Scale

  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.

  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

Study Arms (1)

telerehabilitation

EXPERIMENTAL

pre-post telerehabilltation

Other: pulmonory based home exercises

Interventions

pulmonory based home exercises OTHER

web based telerehablitation

Also known as: telerehabilitation

telerehabilitation

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Anıl Tosun: lead
• Trakya University: collaborator

Study Sites (1)

Fenerbahce University

Istanbul, 34758, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis; Patient Compliance

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Anıl Tosun, Dr.

  Fenerbahce University

  STUDY CHAIR

• Hilal Keklicek, Asc.Prof.

  Trakya University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: April 18, 2021
• First Posted: May 14, 2021
• Study Start: April 16, 2021
• Primary Completion: June 30, 2021
• Study Completion: August 30, 2021
• Last Updated: May 14, 2021

Record last verified: 2021-05

Locations

TU (1)