Actively Recruiting

Phase Not Applicable
All Genders
ID06532903

Evaluation of Functional Recovery of Facial Paralysis in People With Different Kinesic Treatment Options

Led by Universidad Nacional del Nordeste, Argentina · Updated on 2024-08-01

50

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

U

Universidad Nacional del Nordeste, Argentina

Lead Sponsor

N

National Council of Scientific and Technical Research, Argentina

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the recovery process of muscle function in people with peripheral facial paralysis, including Bell's palsy and idiopathic facial paralysis. This controlled, single-blind clinical study compares kinesthetic treatment combined with selective muscle electrostimulation to kinesthetic treatment without electrostimulation. The study is conducted at the UNNE University Kinesiology Service from 2023 to 2025, aiming to promote early social reintegration for participants. Participants are divided into two groups: one receives standard facial muscle reeducation exercises in front of a mirror combined with selective muscle electrostimulation using exponential currents, and the other receives the same muscle reeducation without electrostimulation. The electrostimulation parameters are personalized through an "electroevaluation" to identify the optimal pulse width and intensity for visible, selective muscle contraction. Treatment involves daily sessions with guided facial gestures and muscle activation techniques. Participants undergo initial and final evaluations using the House Brackman and Sunnybrook scales, with assessments blinded to treatment. Researchers record facial movements via video and photographic documentation, as well as clinical monitoring sheets. Functional recovery is measured by muscle function, facial symmetry, and recovery time categorized by the number of treatment sessions. The study monitors participants over 24 months, with follow-up visits to assess progress and ensure safety throughout the treatment period.

CONDITIONS

Brief Title

Functional Recovery From Facial Paralysis

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with a medical referral diagnosing peripheral facial paralysis, Bell's palsy, frigori facial paralysis, or idiopathic facial paralysis
  • Patients who have not received prior kinesic (physical therapy) treatment for facial paralysis
Not Eligible

You will not qualify if you...

  • Patients with central facial paralysis related to stroke
  • Patients with peripheral facial paralysis lasting more than 6 months
  • Patients with skin lesions such as open wounds, lacerations, or burns interfering with electrical stimulation
  • Patients with a medical prescription advising against the use of electrostimulation

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 24 months

Participants receive facial muscle reeducation in front of a mirror. Those in the study group also receive selective muscle electrostimulation with exponential currents to aid recovery from facial paralysis.

Number of treatment sessions varies; treatment continues until kinesic discharge which may be short term (up to 7 sessions), medium term (up to 15 sessions), or long term (greater than 15 sessions)

Trial Site Locations

Total: 1 location

1

Servicio Universitario de Kinesiologia

Corrientes, Argentina, 3400

Actively Recruiting

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Research Team

J

JESSICA A ZALAZAR, INVESTIGADOR

L

LAURA E LEYES, INVESTIGADOR

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Efficacy of adding selective electrical muscle stimulation to usual physical therapy for Bell's palsy: immediate and six-month outcomes.

Antonio Di Pietro, Michelle Cameron, Vilma Campana...

https://pubmed.ncbi.nlm.nih.gov/37877154