Teleassessment in Ataxic Multiple Sclerosis

Completed

• Conditions: Multiple Sclerosis; Ataxia

• Registration Number: NCT05585541
• Lead Sponsor: Hacettepe University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-10-13
• Study First Submitted QC: 2022-10-14
• Study First Posted: 2022-10-19
• Study Start: 2022-10-24
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SARA	up to 6 months	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.
ICARS	up to 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Montreal Cognitive Assessment (MoCA)	up to 6 months	It will be used in the cognitive status assessment. Montreal Cognitive Assessment \< 21 is among the exclusion criteria. At the beginning of the study, all patients will be given a MOCA, and patients who do not meet the criteria will not be included in the study. It assesses different cognitive dimensions including attention and concentration, executive functions, memory, language, visuospatial skills, abstract thinking, calculation, and orientation. The lowest score that can be obtained from the scale is 0, and the highest score is 30. Higher scores indicate a better cognitive levels. It is a reliable scale used for cognitive screening for MS patients. The assessment will take 10 minutes.
Telehealth Usability Questionnaire	up to 6 months	It will be used to evaluate the usability of the teleassessment method by patients. After the tele-assesment is over, the questionnaire will be applied. The questionnaire consists of 21 items and patients are asked to rate each item from 1 to 7.The lowest score is 21 and the highest score is 147. A higher score indicates a higher level of usability. It is a reliable and valid questionnaire in MS patients.
Expanded Disability Status Scale (EDSS)	up to 6 months	Being between Expanded Disability Status Scale 3-5 and having a pyramidal system score below 3 are among the inclusion criteria. At the beginning of the study, all patients will be evaluated for EDSS, and patients who do not meet the criteria will not be included in the study. The assessment will take 15 minutes. The EDSS ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. EDSS steps 1.0 to 4.5 refer to people with MS who are able to walk without any aid. EDSS steps 5.0 to 9.5 are defined by the impairment to walking.
Telemedicine Satisfaction Questionnaire	up to 6 months	It will be used to assess patients' satisfaction of the tele assessment method. After the tele-assesment is over, the questionnaire will be applied. The questionnaire consists of 14 items and patients are asked to rate each item from 1 to 5. The lowest score is 14 and the highest score is 70. A higher score indicates a higher level of satisfaction. It is a reliable and valid questionnaire for MS patients.

Trial Locations

Locations (1)

Hacettepe University; 🇹🇷 Ankara, Turkey