Tele-Assessment and Face-to-Face Evaluation of Balance in MS

March 19, 2024 updated by: Ayse Zengin Alpozgen, Istanbul University - Cerrahpasa (IUC)

The Agreement Between Face-to-Face and Tele-Assessment of Balance Tests in Patient With Multiple Sclerosis

MS is characterized by clinical symptoms caused by lesions of the brain, spinal cord, or optic nerves that can affect balance, gait, and risk of falls. 50-80% of patients with MS have different levels of balance-related pathological findings. In addition, the imbalance is one of the most complained about findings by MS patients.

Balance and postural control disorders are the most common signs in patients with cerebellar tract damage. Many patients have reported problems with balance and gait causing serious disability. Therefore, disorders of balance and postural control in patients with MS are associated with difficulty in standing and performing functional activities. Effective quantitative methods are needed to assess postural imbalance to help clinicians assess the progression of this disorder.

Current literature suggests that home tele-rehabilitation and tele-medicine practices may be an alternative method effective enough to be equivalent to face-to-face physiotherapy treatments for patients with Ms. The advantages of Tele-medicine over normal care include increased social support, participant engagement, quality of care, cost-effectiveness, access to services (due to lack of transportation), and reducing the burden on healthcare professionals to make services easier to deploy. In cases such as Pandemic conditions, where face-to-face service is disrupted in clinics, tele-rehabilitation can be applied as a suitable alternative treatment method accessible to patients. The effectiveness of Tele-rehabilitation raises the question of whether tele-evaluation is as effective and accurate as in the clinic. Studies examining the effectiveness of Tele-assesment are still insufficient. The study is planned to address this deficiency.

The aim of this study is to compare the results of MS patients by applying valid and reliable methods used in balance assessment with face-to-face and online access methods, thereby investigating the effectiveness of balance assessment through online access.

The hypothesis in this study is that the results of the balance assessment with online access in MS patients will be consistent with the results of the balance assessment conducted face-to-face.

H0: Tele-assessments of balance do not give the same results as face-to-face balance assessments in MS patients.

H1: Tele-assessments of balance do not give the same results as face-to-face balance assessments in MS patients.

Study Overview

Status

Completed

Conditions

Detailed Description

Voluntary patients who have been diagnosed with MS will be included in the study. Signed voluntary consent will be obtained from participants. Participants will be divided into two groups. Tele-assessment will be applied to one group first, and face-to-face assessment will be applied to the other group first.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Istanbul University Cerrahpasa, Faculty of Health Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients who have been diagnosed with MS

Description

Inclusion Criteria:

  • 18-65 years
  • Patients diagnosed with MS according to McDonald diagnostic criteria with an EDSS score of 0-6
  • Internet presence in the environment where they will perform the evaluation
  • Having an internet-based technological tool or having access to this tool
  • Having someone to accompany the patient during the evaluation
  • Agree to participate in the study
  • Ability to understand and speak Turkish

Exclusion Criteria:

  • Having had a new attack in the last 3 months
  • Use high-dose corticosteroid therapy in the last 2 weeks
  • Presence of orthopedic problems/problems that can cause balance problems
  • Having cognitive disorders that will prevent him from communicating
  • Having a level of visual and auditory problems that will prevent communication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
tele-assessment
The balance evaluations will be applied by the tele-assessment method.
face-to-face assessment
The balance evaluations will be applied by the face-to-face assessment method in a clinical setting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Berg Balance Test
Time Frame: change from baseline at 3rd day
It is a scale containing 14 instructions and a score of 0-4 is given by observing the patient's performance for each instruction. 0 points are given in cases where the patient cannot perform the activity at all, while 4 points are given when the patient completes the activity independently. The highest score is 56 and 0-20 points indicate balance disorder, 21-40 points indicate an acceptable balance, 41-56 points indicate the presence of a good balance. It takes between 10 and 20 minutes to complete the scale.
change from baseline at 3rd day
Dynamic Gait Index
Time Frame: change from baseline at 3rd day
The scale measures mobility function and dynamic balance. The eight tasks of this scale include walking, walking with head turns, turning, walking over objects, walking around objects, and climbing up stairs. The performance is rated on a 4-point scale.
change from baseline at 3rd day
Timed Up and Go Test
Time Frame: change from baseline at 3rd day
The test is a measure of dynamic balance. It requires individuals to get up from a chair, walk 3 feet, turn and sit. The time from the moment the individual lifts the pelvis from the chair until he or she returns with the pelvis in the chair is recorded in seconds.
change from baseline at 3rd day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Investigators

  • Principal Investigator: Ayşe Zengin Alpözgen, Asst.Prof., Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2021

Primary Completion (Actual)

January 16, 2022

Study Completion (Actual)

March 7, 2022

Study Registration Dates

First Submitted

February 3, 2021

First Submitted That Met QC Criteria

February 5, 2021

First Posted (Actual)

February 8, 2021

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-71938118-604.01.01-52315

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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