Teleassessment in Ataxic Multiple Sclerosis

NCT05585541 | Completed

• 1 other identifier: Tele-Assessment
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Ataxia; Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• ICARS

  It will be used to assessment the severity of ataxia. ICARS consists of 4 sub-titles: posture and gait disorders, kinetic functions, speech disorders, and oculomotor disorders. The score range is in the range of 0-100, and higher scores indicate increased disease severity. It is a reliable and valid scale for ataxic MS patients. The assessment will take 20 minutes.

  up to 6 months

• SARA

  It will be used to assess the severity of ataxia. It is a scale that evaluates performance in 8 items as walking, standing, sitting, speech disorder, finger tracking, finger-nose test, rapid alternative hand movements, and heel-tibia test. The score range is 0-40, and an increase in the score indicates increased ataxia severity. It is a reliable and valid scale for ataxic MS patients. The assessment will take 15 minutes.

  up to 6 months

Secondary Outcomes (4)

• Expanded Disability Status Scale (EDSS)

  up to 6 months

• Montreal Cognitive Assessment (MoCA)

  up to 6 months

• Telemedicine Satisfaction Questionnaire

  up to 6 months

• Telehealth Usability Questionnaire

  up to 6 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Ataxic MS patients with inclusion criteria

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ataxia; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Muhammed Kılınç, PhD

  Hacettepe University

  STUDY DIRECTOR

• Ender Ayvat, PhD

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Fatma Ayvat, PhD

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc physiotherapist

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 19, 2022
• Study Start: October 24, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 30, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

TU (1)