ClinicalTrials.gg
CompletedNCT05251558Updated Sep 19, 2024

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

An interventional study of Telerehabilitation and Conventional Education Program in Bell Palsy, sponsored by Muğla Sıtkı Koçman University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Muğla Sıtkı Koçman University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Bell Palsy

Keywords

  • Bells Pasly
  • Telerehabilitation
  • Peripheral Facial Paralysis
  • Proprioceptive Neuromuscular Facilitation
03

In context

Bell Palsy

85 studies on the registry are indexed under Bell Palsy; 30 are open to participants now.

This study's enrollment of 40 is close to the median of 42 across 70 interventional studies indexed under Bell Palsy.

Browse Bell Palsy studies →

Lead sponsor

Muğla Sıtkı Koçman University is the lead sponsor of 114 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherTelerehabilitation

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

  • OtherConventional Education Program

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Change from Baseline FDI at 4 weeks

  2. 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.

    Time frame: Change from Baseline FaCE at 4 weeks

  3. 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.

    Time frame: Change from Baseline SF-12 at 4 weeks

  4. 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.

    Time frame: Change from Baseline HADS at 4 weeks

  5. 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.

    Time frame: Change from Baseline H-B at 4 weeks

Secondary outcomes

  1. 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.

    Time frame: Change from Baseline TSUQ at 4 weeks

07

Study locations

1 site
  • Mugla Sıtkı Kocman University Hospital Emergency Service
    Muğla, Menteşe 48000, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05251558
Responsible party
Fatih Ozden (Principal Investigator, Muğla Sıtkı Koçman University) — Principal investigator
First posted
Feb 22, 2022
Start date
Mar 23, 2023
Primary completion
Aug 15, 2023
Completion
Aug 30, 2023
Last update
Sep 19, 2024

Study contacts

Fatih Özden, PhD
study director · Muğla Sıtkı Koçman University
Mehmet Özkeskin, PhD
principal investigator · Ege University
İsmet Tümtürk, MSc
principal investigator · Süleyman Demirel University
Yalçın Gölcük, MD
principal investigator · Muğla Sıtkı Koçman University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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