Effectiveness of Telerehabilitation Interventions in Multiple Sclerosis

Sponsor
Dokuz Eylul University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05571826
Collaborator
(none)
30
1
13
2.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: telerehabilitation

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Effectiveness of Telerehabilitation Interventions in Persons With Multiple Sclerosis: Patient Perspective
Actual Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
telerehabilitation

Assessments, no specific intervention

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

Outcome Measures

Primary Outcome Measures

  1. Telehealth Usability Questionnaire [Baseline]

    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.

  2. Telemedicine Satisfaction Questionnaire [Baseline]

    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.

Secondary Outcome Measures

  1. Expanded Disability Status Scale [Baseline]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dokuz Eylul University İzmir Turkey

Sponsors and Collaborators

  • Dokuz Eylul University

Investigators

  • Principal Investigator: Serkan Ozakbas, MD, Dokuz Eylul University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Serkan Ozakbas, MD, Dokuz Eylul University
ClinicalTrials.gov Identifier:
NCT05571826
Other Study ID Numbers:
  • 7409-GOA
First Posted:
Oct 7, 2022
Last Update Posted:
Oct 7, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Serkan Ozakbas, MD, Dokuz Eylul University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 7, 2022