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Pattern and Frequency of Non-epileptic Involuntary Movements

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ClinicalTrials.gov Identifier: NCT04083586
Recruitment Status : Not yet recruiting
First Posted : September 10, 2019
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Roaa Almoataz Abdelrazik Zohni Elsabrout, Assiut University

Brief Summary:
We will perform a medical record review of all patients seen in Assiut University hospital, Egypt, to determine the frequency of movement disorders seen, disease characteristics, diagnostic evaluations.

Condition or disease Intervention/treatment
Involuntary Movements Other: All investigations; laboratory and radiological, needed for diagnosis

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: Pattern and Frequency of Non-epileptic Involuntary Movements. Hospital-based Study
Estimated Study Start Date : September 15, 2019
Estimated Primary Completion Date : March 15, 2020
Estimated Study Completion Date : March 15, 2020

Intervention Details:
  • Other: All investigations; laboratory and radiological, needed for diagnosis
    mri brain, ct brain, drug screening


Primary Outcome Measures :
  1. •Detect pattern and clinical characteristics of patients with different forms of movement disorders attending Assiut University neurology outpatient clinic and internal department as parkinson's disease [ Time Frame: from Sep 15th 2019 to March15th 2020. ]
    Using MDS- Unified Parkinson's Disease Rating Scale (UPDRS) (Goetz et al., 2008) for PD. (parts 3) III: Motor Examination, The investigator should "rate what you see.concurrent medical problems and orthopedic problems may interfere with individual items in the motor examination. In situations where it is absolutely impossible to test use the notation "UR" for Unable to Rate. Otherwise, rate the performance of each task as the patient performs in the context of co-morbidities.Do higher values represent a worse outcome

  2. •Detect pattern and clinical characteristics of patients with different forms of movement disorders attending Assiut University neurology outpatient clinic and internal department as dystonia [ Time Frame: from Sep 15th 2019 to March15th 2020. ]
    using Fahn-Marsden rating scale (FMRS), for dystonia. The FMDRS is composed of two clinician-rated subscales: a movement subscale, based on patient examination, and a disability subscale, based on the patient's report of disability in activities of daily living.The movement subscale rates dystonia severity and provoking factors in nine body areas, All items have a 5-point score. The provoking factor rates the relation of dystonia to action, from 0 (no dystonia at rest or with action) to 4 (dystonia at rest).The maximal total FMDRS score is 120. The disability subscale is composed of 7 items for activities of daily living,providing a maximum disability sub- score of 30. Do higher values represent a worse outcome

  3. •Detect pattern and clinical characteristics of patients with different forms of movement disorders attending Assiut University neurology outpatient clinic and internal department as essential tremors [ Time Frame: from Sep 15th 2019 to March15th 2020. ]
    Using • Tremor assessment form (TAF) for tremor: A questionnaire related to hand tremor consisting of 12 items was prospectively applied to patients with PD or ET in three movement-disorder clinics. Each question was analyzed, and a query-based scoring system was evaluated for differentiating hand tremors between PD and ET



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with movement disorders attending Assiut University neurology outpatient clinic and internal department, from Sep 15th 2019 to March15th 2020.

sample size: regarding previously estimated prevalence in (kwon KY et al,2019), was 292, so our sample size as calculated: Sample Size(n) for Various Confidence Levels ________________________________________ Confidence Level(%) Sample Size 95% 167 80% 106 90% 141 97% 181 99% 203 99.9% 231 99.99% 245

________________________________________ Equation Sample size n = [DEFF*Np(1-p)]/ [(d2/Z21-α/2*(N-1)+p*(1-p)]

Results from OpenEpi, Version 3, open source calculator--SSPropor

Criteria

Inclusion Criteria:

  • Patients with movement disorders attending Assiut University neurology outpatient clinic and internal department, from Sep 15th 2019 to March15th 2020.

Exclusion Criteria:

  • 1) involuntary movements epileptic in origin 2) refusal of patient to give consent to join the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04083586


Contacts
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Contact: roaa elsabrout, postgraduate 00201064982780 rosana6@ymail.com
Contact: mohamed abdelhameed, assist prof 00201002629734 moh78_abdelhamed@yahoo.com

Sponsors and Collaborators
Assiut University
Investigators
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Study Chair: Hamdy El-Tallawy, professor Professor of Neurology Faculty of Medicine, Assiut University
Study Director: Ali Shalash, professor Professor of Neurology Faculty of Medicine, Ain Shams University
Study Director: mohamed abdelhameed, assist prof Assistant professor of Neurology Faculty of Medicine, Assiut University
Principal Investigator: roaa elsabrout, postgraduate Resident at neuropsychiatry department Assiut University
Publications:

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Responsible Party: Roaa Almoataz Abdelrazik Zohni Elsabrout, post graduate, Assiut University
ClinicalTrials.gov Identifier: NCT04083586    
Other Study ID Numbers: frequency involuntary movement
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dyskinesias
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms