Teleassessment in Ataxic Multiple Sclerosis

NCT ID: NCT05585541

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-24
• Study Completion Date: 2023-06-30

Brief Summary

Our aim is to compare ICARS and SARA scores with face-to-face and tele-assessment methods in ataxic multiple sclerosis patients.

The hypotheses on which this study is based are; H1: Tele-assessment and face-to-face assessment results of the ICARS differ in patients with ataxic MS.

H2: Tele-assessment and face-to-face assessment results of SARA differ in patients with Ataxic MS.

Detailed Description

Patients will be evaluated both face-to-face and via tele-assessment (video conference call). In these evaluations, ICARS and SARA will be used. Face-to-face and tele-assessments will be applied on the same day, the order of administration will be decided by the randomization method, and a 10-minute rest will be given between the assessments.The interview will be recorded during the tele-assessment and a re-assessment will be made on the same recording 1 week later. Face-to-face assessment will be done as routinely done in the clinic. Face-to-face and tele-assessments will be made by 3 different assessors. Assessors will be blind to each other's assessment. All assessments will be carried out at Hacettepe University Faculty of Physical Therapy and Rehabilitation.

Conditions

Ataxia; Multiple Sclerosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Ataxic multiple sclerosis

In the study, those aged between 18-50 years, diagnosed with MS by a neurologist, Expanded Disability Status Scale (EDSS) score between 3-5, EDSS pyramidal system score ≤ 3 and cerebellar functional system score ≥ 1, patients who have been clinically stable for the last 3 months and have agreed to participate in the study will be included.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• be between the ages of 18-50 years
• Being diagnosed with MS by a neurologist
• Expanded Disability Status Scale (EDSS) score between 3-5
• EDSS pyramidal system score ≤ 3 and cerebellar functional system score ≥ 1
• Being clinically stable for the last 3 months
• agree to participate in the study

Exclusion Criteria

• Having other systemic, orthopedic or neurological disease
• Having a history of attacks in the last 3 months
• having peripheral vestibular complaints
• being mentally affected (Montreal Cognitive Rating Scale Score < 21)
• severe spasticity (Modified Ashworth Scale > 3)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Güngör Beyza ÖZVAR

MSc physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muhammed Kılınç, PhD

Role: STUDY_DIRECTOR

Hacettepe University

Ender Ayvat, PhD

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Fatma Ayvat, PhD

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Locations

Hacettepe University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Tele-Assessment

Identifier Type: -

Identifier Source: org_study_id