NCT05571826

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

October 7, 2022

Status Verified

October 1, 2022

Enrollment Period

1 year

First QC Date

October 6, 2022

Last Update Submit

October 6, 2022

Conditions

Keywords

multiple sclerosisupper extremitytelerehabilitationpatient perspective

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Expanded Disability Status Scale

    Baseline

Study Arms (1)

telerehabilitation

Assessments, no specific intervention

Behavioral: telerehabilitation

Interventions

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

telerehabilitation

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The people with multiple sclerosis who have received exercise training based on synchronous or asynchronous telerehabilitation

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University

Izmir, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Serkan Ozakbas, MD

    Dokuz Eylul University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Serkan Ozakbas, MD

CONTACT

Asiye Tuba Ozdogar, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 6, 2022

First Posted

October 7, 2022

Study Start

October 1, 2022

Primary Completion

October 1, 2023

Study Completion

November 1, 2023

Last Updated

October 7, 2022

Record last verified: 2022-10

Locations