Multiple SclerosisNCT05809505
Feasibility and Safety of the 360-degree Turn Test Delivered Via Telehealth
A study testing 360-degree Turn Test, Expanded Disability Status Scale and Perceived Exertion in people with Multiple Sclerosis, run by Uskudar State Hospital at 1 site in Turkey (Türkiye).
Trial summary
Walking, balance problems and falls are common in patients with multiple sclerosis. The 360-degree turn test is a test used to evaluate balance. Telerehabilitation is a rehabilitation system that has been increasingly used in recent years. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- 360-degree Turn Test, Expanded Disability Status Scale and Perceived Exertion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 1 Jan 2025
- Phase
- Interventional
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of multiple sclerosis
- EDSS score ≤ 5.5
Who cannot join
- Not giving consent
- History of dislocation or surgery in the lower limbs
- History of fall within six months
- Any other disease, medication or intervention that can cause balance disturbance
- Patients who cannot use devices that is required for teleconference
- Patients that cannot understand English/ Turkish
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Başakşehir Çam ve Sakura City Hospital
Istanbul, Başakşehir, 34000
Fatih Bağcıer, Assoc. Prof.
Fatih Bağcıer, Assoc. Prof.
About this study
Walking, balance problems and falls are common in patients with multiple sclerosis. The 360-degree turn test is a test used to evaluate balance. Telerehabilitation is a rehabilitation system that has been increasingly used in recent years. Still, there is a need for studies on whether there is any difference between face-to-face evaluations with patients and telehealth methods. This study aims to investigate the feasibility and safety of the 360-degree turn test delivered via telehealth.
Read the detailed description
The 360-degree turn test will be performed in the participant's home environment using a standardized protocol from previously published literature. Exercise professionals will administer the test during a single videoconferencing exercise appointment. Prior to the study commencement, clinicians will be given a 30-minute education session and written protocol to facilitate the standardized and safe performance of the test.
The test will be performed in the participant's home environment using videoconferencing. The clinician will explain the 360-degree turn test. Clinicians will record the device used by the participant. Where possible, participants will be instructed to adjust their device or camera to improve clinician visibility. The test will be stopped immediately if the participant reports increased pain, a moderate-significant increase in breathlessness, or is unsteady.
- Conditions
- Multiple Sclerosis
- Being tested
- 360-degree Turn Test, Expanded Disability Status Scale, Perceived Exertion
- Keywords
- telehealth, multiple sclerosis, 360-degree Turn Test
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
360-degree Turn TestDiagnostic test
The 360-degree turn test is a measure of dynamic balance. The person tested turns in a complete circle (360 degrees) while the time to complete and/or the number of steps to complete the turn is recorded.
Expanded Disability Status ScaleOther
The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of people with multiple sclerosis. The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability.
Perceived ExertionOther
Also called Borg Scale
The Borg Rating of Perceived Exertion (RPE) is a way of measuring physical activity intensity level. Perceived exertion is how hard you feel like your body is working. It is based on the physical sensations a person experiences during physical activity, including increased heart rate, increased respiration or breathing rate, increased sweating, and muscle fatigue. Although this is a subjective measure, your exertion rating based on a 6 to 20 rating scale, may provide a fairly good estimate of your actual heart rate during physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Multiple Sclerosis Patients | Experimental | Patients with a diagnosis of multiple sclerosis. Receives: Diagnostic Test: 360-degree Turn Test; Other: Expanded Disability Status Scale; Other: Perceived Exertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who safely completed the 360-degree turn test and completed the measurement in a way that could be used in clinical trials or follow-up
Feasibility and safety of the 360-degree turn test delivered via telehealth will be measured by the percived safety from researchers and results of the tests obtained from procedure.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start1 May 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The 360-degree turn test will be applied to patients first in the hospital environment and then by teleconference method, and the results will be recorded.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uskudar State Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mustafa Hüseyin Temel, Uskudar State Hospital
- Investigators
- Mustafa H Temel, M.D., Principal investigator, Uskudar State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809505
- Sponsor's protocol ID
- 360 Degree 1
- Status last verified
- Jun 2023
- First submitted
- 9 Mar 2023
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be shared upon reasonable request by the co-author.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of the 360-degree Turn Test Delivered Via Telehealth
- ClinicalTrials.gov ID
- NCT05809505
- Acronym / sponsor ID
- 360 Degree 1
- Conditions
- Multiple Sclerosis
- Keywords
- telehealth, multiple sclerosis, 360-degree Turn Test
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Uskudar State HospitalOther government
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 12 Apr 2023 (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.
Walking, balance problems and falls are common in patients with multiple sclerosis. The 360-degree turn test is a test used to evaluate balance. Telerehabilitation is a rehabilitation system that has been increasingly used in recent years. Still, there is a need for studies on whether there is any difference between face-to-face evaluations with patients and telehealth methods. This study aims to investigate the feasibility and safety of the 360-degree turn test delivered via telehealth.
Detailed description
The 360-degree turn test will be performed in the participant's home environment using a standardized protocol from previously published literature. Exercise professionals will administer the test during a single videoconferencing exercise appointment. Prior to the study commencement, clinicians will be given a 30-minute education session and written protocol to facilitate the standardized and safe performance of the test.
The test will be performed in the participant's home environment using videoconferencing. The clinician will explain the 360-degree turn test. Clinicians will record the device used by the participant. Where possible, participants will be instructed to adjust their device or camera to improve clinician visibility. The test will be stopped immediately if the participant reports increased pain, a moderate-significant increase in breathlessness, or is unsteady.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The 360-degree turn test will be applied to patients first in the hospital environment and then by teleconference method, and the results will be recorded.
| Arm | Type | Receives |
|---|---|---|
| Multiple Sclerosis Patients | Experimental | Diagnostic Test: 360-degree Turn Test, Other: Expanded Disability Status Scale, Other: Perceived ExertionPatients with a diagnosis of multiple sclerosis. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of multiple sclerosis
- EDSS score ≤ 5.5
Key exclusion criteria (6 listed)
- Not giving consent
- History of dislocation or surgery in the lower limbs
- History of fall within six months
- Any other disease, medication or intervention that can cause balance disturbance
- Patients who cannot use devices that is required for teleconference
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 360-degree Turn TestThe 360-degree turn test is a measure of dynamic balance. The person tested turns in a complete circle (360 degrees) while the time to complete and/or the number of steps to complete the turn is recorded. | Diagnostic test | Multiple Sclerosis Patients |
| Expanded Disability Status ScaleThe Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of people with multiple sclerosis. The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. | Other | Multiple Sclerosis Patients |
| Perceived ExertionAlso: Borg ScaleThe Borg Rating of Perceived Exertion (RPE) is a way of measuring physical activity intensity level. Perceived exertion is how hard you feel like your body is working. It is based on the physical sensations a person experiences during physical activity, including increased heart rate, increased respiration or breathing rate, increased sweating, and muscle fatigue. Although this is a subjective measure, your exertion rating based on a 6 to 20 rating scale, may provide a fairly good estimate of your actual heart rate during physical activity. | Other | Multiple Sclerosis Patients |
Primary outcome
Number of patients who safely completed the 360-degree turn test and completed the measurement in a way that could be used in clinical trials or follow-up
Time frame: 1 day
Feasibility and safety of the 360-degree turn test delivered via telehealth will be measured by the percived safety from researchers and results of the tests obtained from procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Individual participant dataSharing planned: Yes. Individual participant data will be shared upon reasonable request by the co-author.
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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.
Mustafa H Temel, M.D. principal investigator
Uskudar State Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 360-degree Turn Test, Expanded Disability Status Scale and Perceived Exertion in people with Multiple Sclerosis, run by Uskudar State Hospital 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 7 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mustafa H Temel, M.D. (+905342714872, mhuseyintemel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who safely completed the 360-degree turn test and completed the measurement in a way that could be used in clinical trials or follow-up (time frame: 1 day). 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 7 Jun 2023.