Efficacy of Telerehabilitation Based Exercises in Patients With Bell's Palsy

September 11, 2024 updated by: Fatih Ozden, Muğla Sıtkı Koçman University

The Efficacy of Telerehabilitation Based Self Proprioceptive Neuromuscular Facilitation Exercises on Clinical and Psychosocial Parameters in Bell's Palsy Patients

The study will be carried out with volunteer patients who are diagnosed with Bell's Palsy and comply with the study criteria.The aim of the study is to compare the home PNF exercise program with video-based telerehabilitation and the conventional training program in terms of outcome measures in patients with Bell's Palsy lesions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

With the telerehabilitation program, it is aimed that patients can easily adapt to home exercise programs and be followed up remotely. In this way, the most effective treatment of the disease will provide the patient with both motor function gain and psychosocial gain. This study was planned to examine the effectiveness of telerehabilitation in patients with Bell's Palsy.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

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
    • Menteşe
      • Muğla, Menteşe, Turkey, 48000
        • Mugla Sıtkı Kocman University Hospital Emergency Service

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

Description

Inclusion Criteria:

  • Male and female patients aged 18 - 65 years
  • Being diagnosed with Bell's Palsy by a specialist physician
  • Having a lower motor neuron lesion
  • Non-traumatic cases
  • Not having any other neurological deficits
  • Having signed the consent form

Exclusion Criteria:

  • Situations that will prevent assessments or communication with the individual
  • Bilateral involvement
  • Having an operation for facial palsy
  • Having an upper motor neuron lesion
  • Neurological problems that would preclude evaluation and/or treatment.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telerehabilitation (TR)
Self PNF exercises determined for facial muscles (M. Frontalis, M. Orbicularis Oculi, M. Orbicularis Oris, M. Risorius etc.) will be applied.
Other: Telerehabilitation
The telerehabilitation platform is used to deliver the home exercise program.
Active Comparator: Conventional Education Program (CEP)
Education will be given to cases with Bell's Palsy. Some exercises will be suggested in front of the mirror. Patients will be advised to gently massage upwards with their fingertips after applying a warm towel with a towel on the facial muscles.
Other: Conventional Education Program
The patient is given education about the points to be considered for the disease and the exercises to be applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FDI
Time Frame: Change from Baseline FDI at 4 weeks
The Facial Disability Index is a questionnaire that provides information about the impact of facial paralysis and the physical and social well-being impairment it causes. FDI is scored from 0 to 100. Higher scores indicate better function.
Change from Baseline FDI at 4 weeks
FaCE
Time Frame: Change from Baseline FaCE at 4 weeks
It consists of 15 items with responses on a 5-point Likert scale in 6 sub-categories: facial movements, social function, facial comfort, tear control, eye comfort, and mouth function. FaCE is scored from 0 to 100. Higher scores indicate better function.
Change from Baseline FaCE at 4 weeks
SF-12
Time Frame: Change from Baseline SF-12 at 4 weeks
SF 12 is a self-evaluation scale. It consists of seven items. SF-12 is scored from 0 to 100. Higher scores indicate better quality of life.
Change from Baseline SF-12 at 4 weeks
HADS
Time Frame: Change from Baseline HADS at 4 weeks
The scale includes anxiety and depression subscales. The purpose of the scale is not to diagnose, but to determine the risk group by scanning anxiety and depression in a short time in patients with physical illness. HADS is scored from 0 to 21. Higher scores indicate higher depression and anxiety.
Change from Baseline HADS at 4 weeks
H-B
Time Frame: Change from Baseline H-B at 4 weeks
The scale evaluates the four facial regions separately and also assesses the presence of synkinesis. H-B is scored from 4 to 24. Higher scores indicate worse clinical status.
Change from Baseline H-B at 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TSUQ
Time Frame: Change from Baseline TSUQ at 4 weeks
With this survey, the satisfaction levels and usability of individuals using the telemedicine service are evaluated. TSUQ is scored from 21 to 105. Higher scores indicate higher satisfaction and usability.
Change from Baseline TSUQ at 4 weeks

Collaborators and Investigators

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

Sponsor

Muğla Sıtkı Koçman University

Investigators

  • Study Director: Fatih Özden, PhD, Muğla Sıtkı Koçman University
  • Principal Investigator: İsmet Tümtürk, MSc, Suleyman Demirel University
  • Principal Investigator: Yalçın Gölcük, MD, Muğla Sıtkı Koçman University
  • Principal Investigator: Mehmet Ozkeskin, PhD, Ege University

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 23, 2023

Primary Completion (Actual)

August 15, 2023

Study Completion (Actual)

August 30, 2023

Study Registration Dates

First Submitted

January 31, 2022

First Submitted That Met QC Criteria

February 13, 2022

First Posted (Actual)

February 22, 2022

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 11, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BELLS1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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