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

• Sponsor: Lama Saad El-Din Mahmoud (Other)
• Overall Status: Completed
• CT.gov ID: NCT04894513
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.4
• Patients Per Site Per Month: 8.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Facial Nerve Palsy; Bell's Palsy	Other: Kabat motor control re-education therapy; Other: conventional selected program	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: control group which received conventional selected program, and study group received the same exercise training program in addition to Kabat motor control re-education therapycontrol group which received conventional selected program, and study group received the same exercise training program in addition to Kabat motor control re-education therapy
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Electro Physiological Responses to Kabat Motor Control Re-education on Bell's Palsy: A Randomized Controlled Study
• Actual Study Start Date: Feb 15, 2021
• Actual Primary Completion Date: May 15, 2021
• Actual Study Completion Date: May 30, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Electroneurography [6 weeks]

   Measuringthe Facial nerve distal latency measured in millisecond (ms).via the Neuropack S1 MEB9004 EMG device

2. Electroneurography [6 weeks]

   Measuring the Facial nerve amplitude measured in (mv).via the Neuropack S1 MEB9004 EMG device

3. Electroneurography [6 weeks]

   Measuring the Facial nerve percentage of degenerations measured in(%).via the Neuropack S1 MEB9004 EMG device

Secondary Outcome Measures

1. Sunnybrook facial grading system (SBFGS) [6 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 16 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lama S Mahmoud	Al Jīzah	Select State	Egypt

Sponsors and Collaborators

• Lama Saad El-Din Mahmoud

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lama Saad El-Din Mahmoud, Lecturer of physical therapy, Department of Neuromuscular disorders and its surgery, faculty of physical therapy, october 6 univerisity, October 6 University
• ClinicalTrials.gov Identifier: NCT04894513
• Other Study ID Numbers: P.T./REC /012/003143
• First Posted: May 20, 2021
• Last Update Posted: Aug 9, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Bell Palsy; Facial Paralysis; Facial Nerve Diseases; Paralysis

Study Results

No Results Posted as of Aug 9, 2021