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

Bell's Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04894513
• Other study ID #: P.T./REC /012/003143
• Status: Completed
• Phase: N/A
• Start date: February 15, 2021
• Est. completion date: May 30, 2021

Study information

• Verified date: August 2021
• Source: October 6 University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 30, 2021
• Est. primary completion date: May 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Bell Palsy
• Bell's Palsy
• Facial Nerve Diseases
• Facial Nerve Palsy
• Facial Paralysis
• Paralysis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Lama S Mahmoud	Al Jizah	Select State

Sponsors (1)

Lead Sponsor	Collaborator
Lama Saad El-Din Mahmoud

Country where clinical trial is conducted

Egypt, 

Outcome

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