Bell PalsyNCT05251558

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

A study testing Telerehabilitation and Conventional Education Program in people with Bell Palsy, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Bell Palsy
What is being tested?: Telerehabilitation and Conventional Education Program
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 23 Mar 2023to 30 Aug 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Mugla Sıtkı Kocman University Hospital Emergency Service
Muğla, Menteşe, 48000

Other trials in Turkey (Türkiye)

About this study

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

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.

Conditions: Bell Palsy
Being tested: Telerehabilitation, Conventional Education Program
Keywords: Bells Pasly, Telerehabilitation, Peripheral Facial Paralysis, Proprioceptive Neuromuscular Facilitation
Medical subject headings: Bell Palsy, Facial Paralysis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TelerehabilitationOther
The telerehabilitation platform is used to deliver the home exercise program.
Conventional Education ProgramOther
The patient is given education about the points to be considered for the disease and the exercises to be applied.

Study groups in NCT05251558
Study group	Role	What they receive
Telerehabilitation (TR)	Experimental	Self PNF exercises determined for facial muscles (M. Frontalis, M. Orbicularis Oculi, M. Orbicularis Oris, M. Risorius etc.) will be applied. Receives: 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. Receives: Other: Conventional Education Program

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline TSUQ at 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Mar 202330 Aug 2023

First posted22 Feb 2022
Study start23 Mar 2023
Primary completion15 Aug 2023
Study completion30 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Bell PalsyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomised Controlled Trial
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05251558
Sponsor's protocol ID: BELLS1
Status last verified: Sep 2024
First submitted: 31 Jan 2022
Last updated: 19 Sep 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Deep-plane Facelift As A Staged Adjunct To Facial Reanimation : Functional And Aesthetic Outcomes in Comparison to Facial Reanimation Alone
Facial Palsy
RecruitingPhase 3
Steroids for Facial Nerve Function Protection in Post-surgical Vestibular Schwannoma Patients
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Recruiting
Eye-Tracking FP "A Pilot Study of the Quantitative Evaluation of the Attention Paid to Faces With Facial Palsy by the Eye-tracking Technology.
Eye-tracking, Facial Palsy
Not yet recruiting
Mindfulness in Nonflaccid Facial Paralysis
Facial Paralysis
Recruiting
Treatment for "Asymmetric Crying Facies"
Hemifacial Microsomia, Facial Nerve Paralysis

All Bell Palsy trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Efficacy of Telerehabilitation Based Self Proprioceptive Neuromuscular Facilitation Exercises on Clinical and Psychosocial Parameters in Bell's Palsy Patients
ClinicalTrials.gov ID: NCT05251558
Acronym / sponsor ID: BELLS1
Conditions: Bell Palsy
Keywords: Bells Pasly, Telerehabilitation, Peripheral Facial Paralysis, Proprioceptive Neuromuscular Facilitation
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Muğla Sıtkı Koçman UniversityUniversity, hospital or other
Study start: 23 Mar 2023 (actual)
Primary completion: 15 Aug 2023 (actual)
Study completion: 30 Aug 2023 (actual)
First posted: 22 Feb 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Randomised Controlled Trial

Arm	Type	Receives
Telerehabilitation (TR)	Experimental	Other: TelerehabilitationSelf PNF exercises determined for facial muscles (M. Frontalis, M. Orbicularis Oculi, M. Orbicularis Oris, M. Risorius etc.) will be applied.
Conventional Education Program (CEP)	Active comparator	Other: Conventional Education ProgramEducation 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TelerehabilitationThe telerehabilitation platform is used to deliver the home exercise program.	Other	Telerehabilitation (TR)
Conventional Education ProgramThe patient is given education about the points to be considered for the disease and the exercises to be applied.	Other	Conventional Education Program (CEP)

Primary outcome

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.
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.
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.
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.
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.

1 secondary outcome

TSUQ
Time frame: Change from Baseline TSUQ at 4 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Individual participant dataSharing planned: No

Related trials for Bell Palsy

Not yet recruiting
Deep-plane Facelift As A Staged Adjunct To Facial Reanimation : Functional And Aesthetic Outcomes in Comparison to Facial Reanimation Alone
Facial Palsy
RecruitingPhase 3
Steroids for Facial Nerve Function Protection in Post-surgical Vestibular Schwannoma Patients
Vestibular Schwannoma, Facial Nerve Paralysis
Recruiting
Eye-Tracking FP "A Pilot Study of the Quantitative Evaluation of the Attention Paid to Faces With Facial Palsy by the Eye-tracking Technology.
Eye-tracking, Facial Palsy
Not yet recruiting
Mindfulness in Nonflaccid Facial Paralysis
Facial Paralysis
Recruiting
Treatment for "Asymmetric Crying Facies"
Hemifacial Microsomia, Facial Nerve Paralysis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Fatih Özden, PhD study director

Muğla Sıtkı Koçman University

Mehmet Özkeskin, PhD principal investigator

Ege University

İsmet Tümtürk, MSc principal investigator

Süleyman Demirel University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Telerehabilitation and Conventional Education Program in people with Bell Palsy, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FDI (time frame: Change from Baseline FDI at 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05251558.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.