Feasibility and Safety of the 360-degree Turn Test Delivered Via Telehealth

NCT ID: NCT05809505

Last Updated: 2023-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2025-01-01

Brief 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. 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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Multiple Sclerosis Patients

Patients with a diagnosis of multiple sclerosis.

Group Type: EXPERIMENTAL

360-degree Turn Test

Intervention Type: DIAGNOSTIC_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 Scale

Intervention Type: OTHER

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 Exertion

Intervention Type: OTHER

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.

Interventions

360-degree Turn 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.

Intervention Type: DIAGNOSTIC_TEST

Expanded Disability Status Scale

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.

Intervention Type: OTHER

Perceived Exertion

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.

Intervention Type: OTHER

Other Intervention Names

Borg Scale

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of multiple sclerosis
• EDSS score ≤ 5.5

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uskudar State Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Mustafa Hüseyin Temel

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mustafa H Temel, M.D.

Role: PRINCIPAL_INVESTIGATOR

Uskudar State Hospital

Locations

Başakşehir Çam ve Sakura City Hospital

Istanbul, Başakşehir, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Mustafa H Temel, M.D.

Role: CONTACT

mhuseyintemel@gmail.com

+905342714872

Fatih Bağcıer, M.D.

Role: CONTACT

bagcier_42@hotmail.com

+905442429042

Facility Contacts

Fatih Bağcıer, Assoc. Prof.

Role: primary

Other Identifiers

360 Degree 1

Identifier Type: -

Identifier Source: org_study_id