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

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: Bell Palsy
• Intervention / Treatment: Other: Telerehabilitation; Other: Conventional Education Program

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): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fatih Özden, PhD; Phone Number: +90 5434334593; Email: fatihozden@mu.edu.tr

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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	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	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	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	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

• 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 Özkeskin, PhD, Ege University

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2022
• Primary Completion (Actual): July 30, 2023
• Study Completion (Actual): August 5, 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): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Telerehabilitation; Proprioceptive Neuromuscular Facilitation; Bells Pasly; Peripheral Facial Paralysis
• Additional Relevant MeSH Terms: Nervous System Diseases; Virus Diseases; Infections; Neurologic Manifestations; Stomatognathic Diseases; Mouth Diseases; DNA Virus Infections; Cranial Nerve Diseases; Herpesviridae Infections; Paralysis; Facial Nerve Diseases; Bell Palsy; Facial Paralysis
• Other Study ID Numbers: EGE1

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