Facial Nerve PalsyNCT04894513
Electro Physiological Responses to Kabat Motor Control Re-education on Bell's Palsy: A Randomized Controlled Study
A study testing conventional selected program in people with Facial Nerve Palsy and Bell's Palsy, run by Lama Saad El-Din Mahmoud at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Facial Nerve Palsy, Bell's Palsy
- What is being tested?
- conventional selected program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2021to 30 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Thirty child diagnosed as acquired bell's palsy with unilateral peripheral facial paralysis
- Both gender
- Their age ranged from 12:16 years old.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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
- Conditions
- Facial Nerve Palsy, Bell's Palsy
- Being tested
- Kabat motor control re-education therapy, conventional selected program
- Medical subject headings
- Bell Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kabat motor control re-education therapyOther
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 programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | the study group received the conventional selected program in addition to Kabat motor control re-education Receives: Other: Kabat motor control re-education therapy; Other: conventional selected program |
| control group | Experimental | the control group received the conventional selected program Receives: Other: conventional selected program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroneurography
Measuringthe Facial nerve distal latency measured in millisecond (ms).via the Neuropack S1 MEB9004 EMG device
Measured: 6 weeks
Electroneurography
Measuring the Facial nerve amplitude measured in (mv).via the Neuropack S1 MEB9004 EMG device
Measured: 6 weeks
Electroneurography
Measuring the Facial nerve percentage of degenerations measured in(%).via the Neuropack S1 MEB9004 EMG device
Measured: 6 weeks
Secondary outcomes (1)
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start15 Feb 2021
- Primary completion15 May 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Facial Nerve PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lama Saad El-Din Mahmoud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lama Saad El-Din Mahmoud, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894513
- Sponsor's protocol ID
- P.T./REC /012/003143
- Status last verified
- Aug 2021
- First submitted
- 13 Apr 2021
- Last updated
- 9 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hamed SA, Saad El-Din Mahmoud L, Magdy ElMeligie M, Zoheiry IM. Electrophysiological responses to Kabat motor control re-education on Bell's Palsy: A randomized controlled study. J Musculoskelet Neuronal Interact. 2023 Mar 1;23(1):90-97.
PubMed 36856104
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electro Physiological Responses to Kabat Motor Control Re-education on Bell's Palsy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04894513
- Acronym / sponsor ID
- P.T./REC /012/003143
- Conditions
- Facial Nerve Palsy, Bell's Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Lama Saad El-Din MahmoudUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 20 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Other: Kabat motor control re-education therapy, Other: conventional selected programthe study group received the conventional selected program in addition to Kabat motor control re-education |
| control group | Experimental | Other: conventional selected programthe control group received the conventional selected program |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Thirty child diagnosed as acquired bell's palsy with unilateral peripheral facial paralysis
- Both gender
- Their age ranged from 12:16 years old.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kabat motor control re-education therapyKabat 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 | study group |
| conventional selected programthe 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. | Other | control group, study group |
Primary outcome
Electroneurography
Time frame: 6 weeks
Measuringthe Facial nerve distal latency measured in millisecond (ms).via the Neuropack S1 MEB9004 EMG device
Electroneurography
Time frame: 6 weeks
Measuring the Facial nerve amplitude measured in (mv).via the Neuropack S1 MEB9004 EMG device
Electroneurography
Time frame: 6 weeks
Measuring the Facial nerve percentage of degenerations measured in(%).via the Neuropack S1 MEB9004 EMG device
1 secondary outcome
Sunnybrook facial grading system (SBFGS)
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Derived from this study: PubMed 36856104Hamed SA, Saad El-Din Mahmoud L, Magdy ElMeligie M, Zoheiry IM. Electrophysiological responses to Kabat motor control re-education on Bell's Palsy: A randomized controlled study. J Musculoskelet Neuronal Interact. 2023 Mar 1;23(1):90-97.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional selected program in people with Facial Nerve Palsy and Bell's Palsy, run by Lama Saad El-Din Mahmoud at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electroneurography (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04894513, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.