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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05809505
• Other study ID #: 360 Degree 1
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: June 2023
• Source: Uskudar State Hospital
• Contact: Mustafa H Temel, M.D.
• Phone: +905342714872
• Email: mhuseyintemel[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Diagnostic Test:
• 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.

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Basaksehir Çam ve Sakura City Hospital	Istanbul	Basaksehir

Sponsors (1)

Lead Sponsor	Collaborator
Uskudar State Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day