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

Bell Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05251558
• Other study ID #: EGE1
• Status: Completed
• Phase: N/A
• Start date: April 15, 2022
• Est. completion date: August 5, 2023

Study information

• Verified date: August 2023
• Source: Mugla Sitki Koçman University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 5, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bell Palsy
• Facial Paralysis

Intervention

Other:
• Telerehabilitation
The telerehabilitation platform is used to deliver the home exercise program.
• Conventional Education Program
The patient is given education about the points to be considered for the disease and the exercises to be applied.

Locations

Country	Name	City	State
Turkey	Mugla Sitki Kocman University Hospital Emergency Service	Mugla	Mentese

Sponsors (1)

Lead Sponsor	Collaborator
Mugla Sitki Koçman University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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