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NCT Number: NCT05251558

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mugla Sıtkı Kocman University Hospital Emergency Service

Muğla, Menteşe, 48000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

telerehabilitation

Other

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

Conventional Education Program

Other

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

Primary outcomes

  1. FDI

    Time frame: Change from Baseline FDI at 4 weeks

    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.

  2. FaCE

    Time frame: Change from Baseline FaCE at 4 weeks

    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.

  3. SF-12

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

    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.

  4. HADS

    Time frame: Change from Baseline HADS at 4 weeks

    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.

  5. H-B

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

    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 outcomes

  1. TSUQ

    Time frame: Change from Baseline TSUQ at 4 weeks

    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.

Sponsors and collaborators

Lead sponsor

Muğla Sıtkı Koçman University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 22, 2022
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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