NCT04083586

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 10, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

January 15, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2021

Completed
Last Updated

August 9, 2021

Status Verified

August 1, 2021

Enrollment Period

1 year

First QC Date

August 29, 2019

Last Update Submit

August 5, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • •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

    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

    from Dec15th 2019 to June15th 2020.

  • •Detect pattern and clinical characteristics of patients with different forms of movement disorders attending Assiut University neurology outpatient clinic and internal department as dystonia

    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

    from Dec15th 2019 to June15th 2020.

  • •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

    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

    from Dec15th 2019 to June15th 2020.

Interventions

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with movement disorders attending Assiut University neurology outpatient clinic and internal department, from Jan 2020 to Jan 2021. 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

You may qualify if:

  • Patients with movement disorders attending Assiut University neurology outpatient clinic and internal department, from Jan 2020 to Jan 2021.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AssiutU

Asyut, Egypt

Location

Related Publications (12)

  • Sanger TD, Delgado MR, Gaebler-Spira D, Hallett M, Mink JW; Task Force on Childhood Motor Disorders. Classification and definition of disorders causing hypertonia in childhood. Pediatrics. 2003 Jan;111(1):e89-97. doi: 10.1542/peds.111.1.e89.

    PMID: 12509602BACKGROUND
  • Sanger TD, Chen D, Delgado MR, Gaebler-Spira D, Hallett M, Mink JW; Taskforce on Childhood Motor Disorders. Definition and classification of negative motor signs in childhood. Pediatrics. 2006 Nov;118(5):2159-67. doi: 10.1542/peds.2005-3016.

    PMID: 17079590BACKGROUND
  • Swedo SE. Sydenham's chorea. A model for childhood autoimmune neuropsychiatric disorders. JAMA. 1994 Dec 14;272(22):1788-91. doi: 10.1001/jama.272.22.1788. No abstract available.

    PMID: 7661914BACKGROUND
  • Benabid AL, Benazzouz A, Limousin P, Koudsie A, Krack P, Piallat B, Pollak P. Dyskinesias and the subthalamic nucleus. Ann Neurol. 2000 Apr;47(4 Suppl 1):S189-92.

    PMID: 10762147BACKGROUND
  • Janavs JL, Aminoff MJ. Dystonia and chorea in acquired systemic disorders. J Neurol Neurosurg Psychiatry. 1998 Oct;65(4):436-45. doi: 10.1136/jnnp.65.4.436.

    PMID: 9771763BACKGROUND
  • Cardoso F, Eduardo C, Silva AP, Mota CC. Chorea in fifty consecutive patients with rheumatic fever. Mov Disord. 1997 Sep;12(5):701-3. doi: 10.1002/mds.870120512.

    PMID: 9380051BACKGROUND
  • Morris JG, Jankelowitz SK, Fung VS, Clouston PD, Hayes MW, Grattan-Smith P. Athetosis I: historical considerations. Mov Disord. 2002 Nov;17(6):1278-80. doi: 10.1002/mds.10267. No abstract available.

    PMID: 12465068BACKGROUND
  • Caviness JN, Brown P. Myoclonus: current concepts and recent advances. Lancet Neurol. 2004 Oct;3(10):598-607. doi: 10.1016/S1474-4422(04)00880-4.

    PMID: 15380156BACKGROUND
  • Kennedy CH, Meyer KA, Knowles T, Shukla S. Analyzing the multiple functions of stereotypical behavior for students with autism: implications for assessment and treatment. J Appl Behav Anal. 2000 Winter;33(4):559-71. doi: 10.1901/jaba.2000.33-559.

    PMID: 11214031BACKGROUND
  • Swedo SE, Leonard HL, Garvey M, Mittleman B, Allen AJ, Perlmutter S, Lougee L, Dow S, Zamkoff J, Dubbert BK. Pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections: clinical description of the first 50 cases. Am J Psychiatry. 1998 Feb;155(2):264-71. doi: 10.1176/ajp.155.2.264.

    PMID: 9464208BACKGROUND
  • Meierkord H, Fish DR, Smith SJ, Scott CA, Shorvon SD, Marsden CD. Is nocturnal paroxysmal dystonia a form of frontal lobe epilepsy? Mov Disord. 1992;7(1):38-42. doi: 10.1002/mds.870070107.

    PMID: 1557065BACKGROUND
  • El-Tallawy HN, Farghaly WM, Shehata GA, Rageh TA, Hakeem NM, Hamed MA, Badry R. Prevalence of Parkinson's disease and other types of Parkinsonism in Al Kharga district, Egypt. Neuropsychiatr Dis Treat. 2013;9:1821-6. doi: 10.2147/NDT.S48318. Epub 2013 Nov 26.

    PMID: 24379673BACKGROUND

MeSH Terms

Conditions

Dyskinesias

Interventions

LaboratoriesHealth Services Needs and Demand

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Non-Medical Public and Private FacilitiesHealth FacilitiesHealth Care Facilities Workforce and ServicesHealth Services ResearchHealth PlanningHealth Care Economics and OrganizationsDelivery of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Hamdy El-Tallawy, professor

    Professor of Neurology Faculty of Medicine, Assiut University

    STUDY CHAIR
  • 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

    STUDY DIRECTOR
  • roaa elsabrout, postgraduate

    Resident at neuropsychiatry department Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
post graduate

Study Record Dates

First Submitted

August 29, 2019

First Posted

September 10, 2019

Study Start

January 15, 2020

Primary Completion

January 15, 2021

Study Completion

January 15, 2021

Last Updated

August 9, 2021

Record last verified: 2021-08

Locations