Electro Physiological Responses to Kabat Motor Control Re-education on Bell's Palsy: A Randomized Controlled Study

To investigate the Effect of Kabat motor control re-education therapy on facial nerve Electro physiological responses and facial muscles function in bell's palsy.

BACKGROUND: facial nerve recovery in children could be improved through facilitation of nerve regeneration which can be enhanced through Kabat motor control re-education therapy.

Study Overview

• Status: Completed
• Conditions: Bell's Palsy; Facial Nerve Palsy
• Intervention / Treatment: Other: Kabat motor control re-education therapy; Other: conventional selected program

Detailed Description

Thirty children with bell's palsy will participate in this study. The patients will randomly be divided into two equal groups; the control group received the conventional selected program, and the study group received the same exercise training program in addition to Kabat motor control re-education therapy. The program of treatment will be three times per week for six weeks.

The evaluation methods: Facial nerve distal latency, amplitude, and percentage of degenerations via the Neuropack S1 MEB9004 EMG device, the Facial Disability Index, and Sunnybrook facial grading system (SBFGS) all the assessment methods before the program and after finishing the program

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Select State
    • Al Jīzah, Select State, Egypt
      • Lama S Mahmoud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 16 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Thirty child diagnosed as acquired bell's palsy with unilateral peripheral facial paralysis
• Both gender
• Their age ranged from 12:16 years old.

Exclusion Criteria:

• difficulty to communicate or to understand program instructions
• Oral dentures, Skin infection and metal implants on face
• Sensory loss over the face, Recurrent facial paralysis
• any other disorders or neurological deficits,
• a history of surgical intervention for the ear and facial nerve palsy
• pain of any other origin
• non co-operative patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: study group; the study group received the conventional selected program in addition to Kabat motor control re-education	Other: Kabat motor control re-education therapy; Kabat motor control re-education therapy that includes specific movements with predefined patterns of facial muscles exercises, which is spiral and diagonal movements involve the facial muscles, which are brought to train in global patterns. The program of treatment for three times per week for six weeks.; Other: conventional selected program; the conventional selected program in the form of electrical stimulation (Faradic current) of affected muscles, facial muscle exercise program in front of the mirror, and home advices.
EXPERIMENTAL: control group; the control group received the conventional selected program	Other: conventional selected program; the conventional selected program in the form of electrical stimulation (Faradic current) of affected muscles, facial muscle exercise program in front of the mirror, and home advices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electroneurography	Measuringthe Facial nerve distal latency measured in millisecond (ms).via the Neuropack S1 MEB9004 EMG device	6 weeks
Electroneurography	Measuring the Facial nerve amplitude measured in (mv).via the Neuropack S1 MEB9004 EMG device	6 weeks
Electroneurography	Measuring the Facial nerve percentage of degenerations measured in(%).via the Neuropack S1 MEB9004 EMG device	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sunnybrook facial grading system (SBFGS)	it is a clinical grading system of facial function in facial palsy. It consists of 13 items-3 resting, 5 voluntary movement and 5 synkinesis items-answered on categorical answering scales. A SB composite score (range 0-100) and resting symmetry (range 0-20), voluntary movement (range 20-100) and synkinesis subscores (0-15) can be calculated.	6 weeks

Collaborators and Investigators

• Sponsor: Lama Saad El-Din Mahmoud

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 15, 2021
• Primary Completion (ACTUAL): May 15, 2021
• Study Completion (ACTUAL): May 30, 2021

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (ACTUAL): May 20, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 9, 2021
• Last Update Submitted That Met QC Criteria: August 2, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Virus Diseases; Infections; Neurologic Manifestations; Stomatognathic Diseases; Mouth Diseases; DNA Virus Infections; Cranial Nerve Diseases; Herpesviridae Infections; Paralysis; Bell Palsy; Facial Paralysis; Facial Nerve Diseases
• Other Study ID Numbers: P.T./REC /012/003143

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No