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

NCT05809505 | Unknown

• 1 other identifier: 360 Degree 1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

telehealth; multiple sclerosis; 360-degree Turn Test

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Multiple Sclerosis Patients

EXPERIMENTAL

Patients with a diagnosis of multiple sclerosis.

Diagnostic Test: 360-degree Turn Test; Other: Expanded Disability Status Scale; Other: Perceived Exertion

Interventions

360-degree Turn Test 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.

Multiple Sclerosis Patients

Expanded Disability Status Scale 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.

Multiple Sclerosis Patients

Perceived Exertion 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.

Also known as: Borg Scale

Multiple Sclerosis Patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of multiple sclerosis
• EDSS score ≤ 5.5

You may not qualify if:

• 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

Sponsors & Collaborators

• Uskudar State Hospital: lead

Study Sites (1)

Başakşehir Çam ve Sakura City Hospital

Istanbul, Başakşehir, 34000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Mustafa H Temel, M.D.

  Uskudar State Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mustafa H Temel, M.D.

CONTACT

+905342714872; mhuseyintemel@gmail.com

Fatih Bağcıer, M.D.

CONTACT

+905442429042; bagcier_42@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The researchers who evaluate the results and make statistics will be blinded.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: April 12, 2023
• Study Start: May 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: June 7, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: One year
• Access Criteria: Individual participant data will be shared upon reasonable request by the co-author.

Locations

TU (1)