Feasibility and Safety of the 360-degree Turn Test Delivered Via Telehealth
Primary Purpose
Multiple Sclerosis
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
360-degree Turn Test
Expanded Disability Status Scale
Perceived Exertion
Sponsored by
About this trial
This is an interventional diagnostic trial for Multiple Sclerosis focused on measuring telehealth, multiple sclerosis, 360-degree Turn Test
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
Sites / Locations
- Başakşehir Çam ve Sakura City HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Multiple Sclerosis Patients
Arm Description
Patients with a diagnosis of multiple sclerosis.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05809505
Brief Title
Feasibility and Safety of the 360-degree Turn Test Delivered Via Telehealth
Official Title
Feasibility and Safety of the 360-degree Turn Test Delivered Via Telehealth
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uskudar State Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
telehealth, multiple sclerosis, 360-degree Turn Test
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Masking Description
The researchers who evaluate the results and make statistics will be blinded.
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Multiple Sclerosis Patients
Arm Type
Experimental
Arm Description
Patients with a diagnosis of multiple sclerosis.
Intervention Type
Diagnostic Test
Intervention Name(s)
360-degree Turn Test
Intervention Description
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
Other
Intervention Name(s)
Expanded Disability Status Scale
Intervention Description
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
Intervention Name(s)
Perceived Exertion
Other Intervention Name(s)
Borg Scale
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mustafa H Temel, M.D.
Phone
+905342714872
Email
mhuseyintemel@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fatih Bağcıer, M.D.
Phone
+905442429042
Email
bagcier_42@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mustafa H Temel, M.D.
Organizational Affiliation
Uskudar State Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Başakşehir Çam ve Sakura City Hospital
City
Istanbul
State/Province
Başakşehir
ZIP/Postal Code
34000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatih Bağcıer, Assoc. Prof.
First Name & Middle Initial & Last Name & Degree
Fatih Bağcıer, Assoc. Prof.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data will be shared upon reasonable request by the co-author.
IPD Sharing Time Frame
One year
IPD Sharing Access Criteria
Individual participant data will be shared upon reasonable request by the co-author.
Learn more about this trial
Feasibility and Safety of the 360-degree Turn Test Delivered Via Telehealth
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