Electro Physiological Responses to Kabat Motor Control Re-education on Bell's Palsy: A Randomized Controlled Study
Primary Purpose
Facial Nerve Palsy, Bell's Palsy
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Kabat motor control re-education therapy
conventional selected program
Sponsored by
About this trial
This is an interventional treatment trial for Facial Nerve Palsy
Eligibility Criteria
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
Sites / Locations
- Lama S Mahmoud
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
study group
control group
Arm Description
the study group received the conventional selected program in addition to Kabat motor control re-education
the control group received the conventional selected program
Outcomes
Primary Outcome Measures
Electroneurography
Measuringthe Facial nerve distal latency measured in millisecond (ms).via the Neuropack S1 MEB9004 EMG device
Electroneurography
Measuring the Facial nerve amplitude measured in (mv).via the Neuropack S1 MEB9004 EMG device
Electroneurography
Measuring the Facial nerve percentage of degenerations measured in(%).via the Neuropack S1 MEB9004 EMG device
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04894513
First Posted
April 13, 2021
Last Updated
August 2, 2021
Sponsor
Lama Saad El-Din Mahmoud
1. Study Identification
Unique Protocol Identification Number
NCT04894513
Brief Title
Electro Physiological Responses to Kabat Motor Control Re-education on Bell's Palsy: A Randomized Controlled Study
Official Title
Electro Physiological Responses to Kabat Motor Control Re-education on Bell's Palsy: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
May 15, 2021 (Actual)
Study Completion Date
May 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lama Saad El-Din Mahmoud
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facial Nerve Palsy, Bell's Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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 therapy
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Description
the study group received the conventional selected program in addition to Kabat motor control re-education
Arm Title
control group
Arm Type
Experimental
Arm Description
the control group received the conventional selected program
Intervention Type
Other
Intervention Name(s)
Kabat motor control re-education therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
conventional selected program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Electroneurography
Description
Measuringthe Facial nerve distal latency measured in millisecond (ms).via the Neuropack S1 MEB9004 EMG device
Time Frame
6 weeks
Title
Electroneurography
Description
Measuring the Facial nerve amplitude measured in (mv).via the Neuropack S1 MEB9004 EMG device
Time Frame
6 weeks
Title
Electroneurography
Description
Measuring the Facial nerve percentage of degenerations measured in(%).via the Neuropack S1 MEB9004 EMG device
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Sunnybrook facial grading system (SBFGS)
Description
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.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Lama S Mahmoud
City
Al Jīzah
State/Province
Select State
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Electro Physiological Responses to Kabat Motor Control Re-education on Bell's Palsy: A Randomized Controlled Study
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