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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05571826
Other study ID # 7409-GOA
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2022
Est. completion date November 1, 2023

Study information

Verified date October 2022
Source Dokuz Eylul University
Contact Serkan Ozakbas, MD
Phone 0232 412 4964
Email serkan.ozakbas@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Multiple sclerosis (MS) is an inflammatory, demyelinating, neurodegenerative disease of the central nervous system of unknown etiology. The most common clinical signs and symptoms are motor dysfunction, fatigue, spasticity, impaired mobility, cognitive impairment, chronic pain, depression, decreased quality of life, and bladder and bowel dysfunction. 66% of people with MS have impaired upper extremity function. As a result of the deterioration in upper extremity function, the performance of many daily living activities affects performance. As a result of this influence, there is a decrease in the functional independence of people, quality of life, and participation in activities in the community. Exercise training represents an existing behavioral treatment approach to safely manage many functional, symptomatic, and quality-of-life outcomes in MS. Telerehabilitation has been defined as "the delivery of rehabilitation services through information and communication technologies." Telerehabilitation has proven to be useful for people with MS by increasing physical activity and reducing fatigue. In the studies, telerehabilitation and face-to-face rehabilitation services were compared, and stated that they had similar results. At the same time, it was stated that telerehabilitation provides people with gains in terms of time and cost. In addition to all these, the researchers emphasized the benefits they received from telerehabilitation from the people's statements. Therefore, the results of this study, which will be performed on MS patients, will enable the evaluation of telerehabilitation strategies from the patient's point of view. The participants was included in the study titled 'Investigation of the Effects of the Synchronized Telerehabilitation-based Upper Extremity Training Program on Hand-arm Function, Pain, Fatigue, Quality of Life, and Participation in People With Multiple Sclerosis (ClinicalTrials.gov Identifier: NCT05073731)' will be included in this study. Questionnaires that will enable individuals to evaluate their telerehabilitation service will be administered once. Physicians and physiotherapists will make evaluations.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date November 1, 2023
Est. primary completion date October 1, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Having a definitive diagnosis of MS according to the 2017 McDonald criteria - Being over 18 years old - Volunteering to participate in the study - To have received exercise training based on synchronous or asynchronous telerehabilitation Exclusion Criteria: - Having a neurological disease other than MS - Having an MS attack 30 days before or during the study - Cognitive disability at a level that hinders assessment and treatment.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
telerehabilitation
No specific treatments will be applied. The persons who experienced telerehabilitation interventions will be included.

Locations

Country Name City State
Turkey Dokuz Eylul University Izmir

Sponsors (1)

Lead Sponsor Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Telehealth Usability Questionnaire Telehealth Usability Questionnaire was developed by Bakken et al. in 2006. The 21-item questionnaire evaluated the satisfaction and usability of people receiving telemedicine services. A 5-item Likert scale is used in the evaluation. The total score ranges from 21 to 105. Turkish validity and reliability were established. Baseline
Primary Telemedicine Satisfaction Questionnaire Demiris et al. Developed by It consist of 17 items in total. A 5-item Likert-type scale is used to evaluate telemedicine service, expectation, satisfaction, and usability of people. The total score is scored between 17 and 85. Turkish validity and reliability were established. Baseline
Secondary Expanded Disability Status Scale Expanded Disability Status Scale is a method of quantifying disability in multiple sclerosis. The Expanded Disability Status Scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Baseline
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