- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05571826
Effectiveness of Telerehabilitation Interventions in Multiple Sclerosis
Effectiveness of Telerehabilitation Interventions in Persons With Multiple Sclerosis: Patient Perspective
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Serkan Ozakbas, MD
- Phone Number: 0232 412 4964
- Email: serkan.ozakbas@gmail.com
Study Locations
-
-
-
İzmir, Turkey
- Recruiting
- Dokuz Eylul University
-
Contact:
- Serkan Ozakbas, MD
- Phone Number: 0232 412 4964
- Email: serkan.ozakbas@gmail.com
-
Contact:
- Asiye Tuba Ozdogar, PhD
- Email: tuba.ozdogar@yahoo.com
-
Sub-Investigator:
- Ozge Ertekin, PhD
-
Sub-Investigator:
- Turhan Kahraman, PhD
-
Sub-Investigator:
- Asiye Tuba Ozdogar, PhD
-
Sub-Investigator:
- Cavid Baba, MD
-
Sub-Investigator:
- Seda Dastan, Bachelor
-
Principal Investigator:
- Serkan Ozakbas, MS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
telerehabilitation
Assessments, no specific intervention
|
No specific treatments will be applied.
The persons who experienced telerehabilitation interventions will be included.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Telehealth Usability Questionnaire
Time Frame: 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.
|
Baseline
|
|
Telemedicine Satisfaction Questionnaire
Time Frame: 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.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Expanded Disability Status Scale
Time Frame: 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.
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Serkan Ozakbas, MD, Dokuz Eylul University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7409-GOA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Multiple Sclerosis
-
University Hospital, Basel, SwitzerlandSwiss National Science FoundationRecruitingMultiple Sclerosis (MS) | Relapsing-remitting Multiple Sclerosis (RRMS) | Secondary-progressive Multiple Sclerosis (SPMS) | Primary Progressive Multiple Sclerosis (PPMS)Switzerland
-
University of California, Los AngelesUnknownRelapsing-remitting Multiple Sclerosis | Secondary-progressive Multiple Sclerosis | Primary-progressive Multiple SclerosisUnited States
-
BiogenCompletedMultiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Remittent ProgressiveJapan
-
Cabaletta BioNot yet recruitingProgressive Multiple Sclerosis | Multiple Sclerosis | Multiple Sclerosis (Relapsing Remitting) | Relapsing Multiple Sclerosis (RMS) | Progressive Multiple Sclerosis (PMS) | Multiple Sclerosis (MS) - Relapsing-remitting | Multiple Sclerosis - Relapsing Remitting
-
The Cleveland ClinicUniversity Hospitals Cleveland Medical CenterCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Progressive Relapsing Multiple SclerosisUnited States
-
Icahn School of Medicine at Mount SinaiColumbia University; New York Stem Cell Foundation Research InstituteCompletedClinically Isolated Syndrome | Relapsing-Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
Novartis PharmaceuticalsCompletedRelapsing-remitting Multiple Sclerosis | Active Secondary Progressive Multiple SclerosisJapan
-
Banc de Sang i TeixitsVall d'Hebron Research Institute (VHIR)CompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple SclerosisSpain
-
BiogenElan PharmaceuticalsCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
Rigshospitalet, DenmarkOdense University Hospital; Aarhus University Hospital; University of Copenhagen and other collaboratorsActive, not recruitingRelapsing Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisDenmark
Clinical Trials on telerehabilitation
-
University of SalernoAzienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'AragonaRecruiting
-
Saglik Bilimleri UniversitesiCompletedQuality of Life | Fatigue | Muscle Weakness | Pulmonary Disease | COPD | Respiratory Disease | Dyspnea | Muscle Strength | Functional Capacity | Severe Chronic Obstructive Pulmonary Disease | Motor Imagery | Muscle; AccessoryTurkey
-
Biruni UniversityNot yet recruitingPremature Birth of Newborn | Motor Delay | Risky BabyTurkey (Türkiye)
-
Marmara UniversityCompletedHemiparetic Cerebral PalsyTurkey
-
Bright Cloud International CorpNational Cancer Institute (NCI); Rutgers, The State University of New JerseyRecruitingCognitive Impairment, MildUnited States
-
University of Eastern FinlandOulu University Hospital; Kuopio University HospitalRecruiting
-
Sakarya Applied Sciences UniversityNot yet recruitingMusculoskeletal Diseases | Postural; Defect | DriveTurkey
-
King Saud UniversityRecruitingKnee OsteoarthritisSaudi Arabia
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaRecruitingCoronavirus Infections | Quality of Life | Covid19 | Respiratory Failure | ARDS | Dyspnea | Respiratory Rehabilitation | Sars-CoV-2 | Interstitial PneumoniaItaly
-
SOS Oxygene MediterraneeRecruitingExercise | Chronic Respiratory DiseaseFrance