AtaxiaNCT05585541
Teleassessment in Ataxic Multiple Sclerosis
An observational study of Ataxia and Multiple Sclerosis, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Ataxia, Multiple Sclerosis
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Oct 2022to 30 Jun 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Ataxic MS patients with inclusion criteria
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Medical subject headings
- Ataxia, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 6 months
Secondary outcomes (4)
Expanded Disability Status Scale (EDSS)
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.
Measured: up to 6 months
Montreal Cognitive Assessment (MoCA)
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.
Measured: up to 6 months
Telemedicine Satisfaction Questionnaire
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.
Measured: up to 6 months
Telehealth Usability Questionnaire
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.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start24 Oct 2022
- Primary completion1 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtaxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Güngör Beyza ÖZVAR, Hacettepe University
- Investigators
- Muhammed Kılınç, PhD, Study director, Hacettepe UniversityEnder Ayvat, PhD, Principal investigator, Hacettepe UniversityFatma Ayvat, PhD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585541
- Sponsor's protocol ID
- Tele-Assessment
- Status last verified
- Feb 2024
- First submitted
- 13 Oct 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05585541
- Acronym / sponsor ID
- Tele-Assessment
- Conditions
- Ataxia, Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 19 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Ataxic MS patients with inclusion criteria
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ICARS
Time frame: 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.
SARA
Time frame: 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.
4 secondary outcomes
Expanded Disability Status Scale (EDSS)
Time frame: up to 6 months
Montreal Cognitive Assessment (MoCA)
Time frame: up to 6 months
Telemedicine Satisfaction Questionnaire
Time frame: up to 6 months
Telehealth Usability Questionnaire
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammed Kılınç, PhD study director
Hacettepe University
Ender Ayvat, PhD principal investigator
Hacettepe University
Fatma Ayvat, PhD principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ataxia and Multiple Sclerosis, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICARS (time frame: up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.