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

Primary Purpose

Bell Palsy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Telerehabilitation
Conventional Education Program
Sponsored by
Muğla Sıtkı Koçman University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bell Palsy focused on measuring Bells Pasly, Telerehabilitation, Peripheral Facial Paralysis, Proprioceptive Neuromuscular Facilitation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mugla Sıtkı Kocman University Hospital Emergency Service

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telerehabilitation (TR)

Conventional Education Program (CEP)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 31, 2022
Last Updated
August 7, 2023
Sponsor
Muğla Sıtkı Koçman University
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1. Study Identification

Unique Protocol Identification Number
NCT05251558
Brief Title
Efficacy of Telerehabilitation Based Exercises in Patients With Bell's Palsy
Official Title
The Efficacy of Telerehabilitation Based Self Proprioceptive Neuromuscular Facilitation Exercises on Clinical and Psychosocial Parameters in Bell's Palsy Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
April 15, 2022 (Actual)
Primary Completion Date
July 30, 2023 (Actual)
Study Completion Date
August 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Muğla Sıtkı Koçman University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bell Palsy
Keywords
Bells Pasly, Telerehabilitation, Peripheral Facial Paralysis, Proprioceptive Neuromuscular Facilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised Controlled Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telerehabilitation (TR)
Arm Type
Experimental
Arm Description
Self PNF exercises determined for facial muscles (M. Frontalis, M. Orbicularis Oculi, M. Orbicularis Oris, M. Risorius etc.) will be applied.
Arm Title
Conventional Education Program (CEP)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Telerehabilitation
Intervention Description
The telerehabilitation platform is used to deliver the home exercise program.
Intervention Type
Other
Intervention Name(s)
Conventional Education Program
Intervention Description
The patient is given education about the points to be considered for the disease and the exercises to be applied.
Primary Outcome Measure Information:
Title
FDI
Description
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
Title
FaCE
Description
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
Title
SF-12
Description
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
Title
HADS
Description
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
Title
H-B
Description
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 Outcome Measure Information:
Title
TSUQ
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatih Özden, PhD
Organizational Affiliation
Muğla Sıtkı Koçman University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mehmet Özkeskin, PhD
Organizational Affiliation
Ege University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
İsmet Tümtürk, MSc
Organizational Affiliation
Süleyman Demirel University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yalçın Gölcük, MD
Organizational Affiliation
Muğla Sıtkı Koçman University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mugla Sıtkı Kocman University Hospital Emergency Service
City
Muğla
State/Province
Menteşe
ZIP/Postal Code
48000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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