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The Effect Vitamin D Level on the Recovery Rate of Bell Palsy

Sponsor
Umraniye Education and Research Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05997199
Collaborator
(none)
25
Enrollment
1
Location
3.5
Anticipated Duration (Months)
7.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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. All the patients will be included in a standard physical therapy program. The patients will be asked for a control visit at weeks 4 and 8. Their clinical recovery will be evaluated by HB staging and FDI by the Physical Medicine and Rehabilitation specialist who is blind to the serum vitamin D results.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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. A physical therapy program in the form of a standard exercise program including facial paralysis exercises and mirror exercises will be organized for the patients. The patients will be evaluated at 4th and 8th week by HB and FDI. Their Vitamin D level and the recovery rate will be compared.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    25 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Effect of Serum Vitamin D Level on the Recovery Rate of Bell Palsy
    Actual Study Start Date :
    Jun 1, 2023
    Anticipated Primary Completion Date :
    Sep 1, 2023
    Anticipated Study Completion Date :
    Sep 15, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Houseman Brahman (HB) Level [HB stages of the patients will be recorded at week 0,4 and 8.]

      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.

    2. Facial Disability Index (FDI) [FDI of the patients will be recorded at week 0,4 and 8.]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Özlem Kaleoğlu Istanbul Üsküdar Turkey 34000

    Sponsors and Collaborators

    • Umraniye Education and Research Hospital

    Investigators

    • Principal Investigator: Özlem Kaleoğlu, M.D, Umraniye Education and Research Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Özlem Kaleoğlu Aslan, Principle Investigator, Umraniye Education and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT05997199
    Other Study ID Numbers:
    • B.10.1.THK.4.34.H.GP.0.01/76
    First Posted:
    Aug 18, 2023
    Last Update Posted:
    Aug 23, 2023
    Last Verified:
    Aug 1, 2023
    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
    Vitamin D Deficiency

    Study Results

    No Results Posted as of Aug 23, 2023