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

NCT05251558 | Completed

• 1 other identifier: BELLS1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bell Palsy

Keywords

Bells Pasly; Telerehabilitation; Peripheral Facial Paralysis; Proprioceptive Neuromuscular Facilitation

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• TSUQ

  Change from Baseline TSUQ at 4 weeks

Study Arms (2)

Telerehabilitation (TR)

EXPERIMENTAL

Self PNF exercises determined for facial muscles (M. Frontalis, M. Orbicularis Oculi, M. Orbicularis Oris, M. Risorius etc.) will be applied.

Other: Telerehabilitation

Conventional Education Program (CEP)

ACTIVE COMPARATOR

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

Interventions

Telerehabilitation OTHER

The telerehabilitation platform is used to deliver the home exercise program.

Telerehabilitation (TR)

Conventional Education Program OTHER

The patient is given education about the points to be considered for the disease and the exercises to be applied.

Conventional Education Program (CEP)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

Study Sites (1)

Mugla Sıtkı Kocman University Hospital Emergency Service

Muğla, Menteşe, 48000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bell Palsy; Facial Paralysis

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Mouth Diseases; Stomatognathic Diseases; Facial Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Fatih Özden, PhD

  Muğla Sıtkı Koçman University

  STUDY DIRECTOR

• Mehmet Özkeskin, PhD

  Ege University

  PRINCIPAL INVESTIGATOR

• İsmet Tümtürk, MSc

  Süleyman Demirel University

  PRINCIPAL INVESTIGATOR

• Yalçın Gölcük, MD

  Muğla Sıtkı Koçman University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomised Controlled Trial

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 22, 2022
• Study Start: March 23, 2023
• Primary Completion: August 15, 2023
• Study Completion: August 30, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)