The Effect Vitamin D on the Recovery Rate of Bell Palsy

Study Overview
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Brief Summary
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Patients aged between 18-65 who visit the Physical Medicine and Rehabilitation outpatient clinic diagnosed with Bell Palsy will be included in the study. The patients' Bell Palsy grade will be evaluated by Houseman Brahman (HB) Scale and their disability level will be evaluated by Facial Disability Index (FDI). Their serum vitamin D level will be noted. The patients having vitamin D deficiency will be randomized into two groups. Group 1 will be given 50.000 IU/week vitamin D replacement for 8 weeks. All the patients will be included in a standard physical therapy and home exercise program. Both groups will be asked for a control visit at weeks 8.Their clinical recovery will be evaluated by HB staging and FDI by the Physical Medicine and Rehabilitation specialist who is blind to the randomization.

Detailed Description
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Patients aged between 18-65 who visit the Physical Medicine and Rehabilitation outpatient clinic diagnosed with Bell Palsy will be included in the study. Facial palsy stages of patients will be graded from 1 to 6 according to the Houseman Brahman (HB) staging system. In order to determine the disability criteria of the patients, a form called Facial Disability Index (FDI)-Facial Disability Index will be filled. This scale consists of 10 questions and is a validated test evaluating the physical and social function of the patient. The patients having vitamin D deficiency will be randomized into two groups. One group will be getting a vitamin d replacement treatment for 8 weeks. A physical therapy program in the form of a standard exercise program including electrical stimulation and facial paralysis exercises will be organized for all the patients. The patients will be evaluated at 8th week by HB and FDI.

Official Title
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The Effect of Serum Vitamin D on the Recovery Rate of Bell Palsy

Conditions
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Bell Palsy, Vitamin D Deficiency, Facial Paralysis

Intervention / Treatment
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* Dietary Supplement: Vitamin D replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being cooperative-orientated Willing to participate in the Physical Therapy home exercise program Exclusion Criteria: Being Non cooperative, disorientated Failure to comply with the Physical Therapy home exercise program History of malignancy Additional neurological disease Having cranial pathologies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Patients with vitamin D deficiency and having Vitamin D Replacement | Dietary Supplement: Vitamin D replacement<br>* Group 1 with vitamin D deficiency will be getting a standart vitamin D replacement of 50.000 IU/week for 8 weeks.<br>|
| Group 2<br>Control Group. Patients with vitamin D deficiency but not getting Vitamin D replacement | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Houseman Brahman (HB) Level | Facial palsy stages of patients will be graded from 1 to 6 according to the Houseman Brahman (HB) staging system. Grade 1 refers to normal facial nerve function whereas 6 refer to complete paralysis. | HB stages of the patients will be recorded at week 8. | 
| Facial Disability Index (FDI) | This scale consists of 10 questions and is a validated test evaluating the physical and social function of the patient. It is scored out of 100. Higher score is the best result. | FDI of the patients will be recorded at week 8. |