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

Not Applicable

Recruiting

• Conditions: Multiple Sclerosis
• Interventions: Diagnostic Test: 360-degree Turn Test; Other: Expanded Disability Status Scale; Other: Perceived Exertion

• Registration Number: NCT05809505
• Lead Sponsor: Uskudar State Hospital

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.

Study Timeline

• Study First Submitted: 2023-03-09
• Study First Submitted QC: 2023-04-09
• Study First Posted: 2023-04-12
• Study Start: 2023-05-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-05
• Last Update Posted: 2023-06-07
• Primary Completion: 2024-12-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Multiple Sclerosis Patients	Expanded Disability Status Scale	Patients with a diagnosis of multiple sclerosis.
Multiple Sclerosis Patients	360-degree Turn Test	Patients with a diagnosis of multiple sclerosis.
Multiple Sclerosis Patients	Perceived Exertion	Patients with a diagnosis of multiple sclerosis.

Primary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

Başakşehir Çam ve Sakura City Hospital; 🇹🇷 Istanbul, Başakşehir, Turkey