Clinical trial NCT05585541: Teleassessment in Ataxic Multiple Sclerosis
Official title: Comparison of the International Cooperative Ataxia Rating Scale (ICARS) and Scale for the Assessment and Rating of Ataxia (SARA) Scores With Face-to-Face and Tele-Assessment Methods in Ataxic Multiple Sclerosis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ataxia
Multiple Sclerosis
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2022-10-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ataxic MS patients with inclusion criteria

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.

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)

Primary outcomes:
measure: ICARS
timeFrame: up to 6 months
measure: SARA
timeFrame: up to 6 months
Secondary outcomes:
measure: Expanded Disability Status Scale (EDSS)
timeFrame: up to 6 months
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: up to 6 months
measure: Telemedicine Satisfaction Questionnaire
timeFrame: up to 6 months
measure: Telehealth Usability Questionnaire
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Muhammed Kılınç, PhD
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Ender Ayvat, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Fatma Ayvat, PhD
role: PRINCIPAL_INVESTIGATOR
References: