- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04083586
Pattern and Frequency of Non-epileptic Involuntary Movements
Pattern and Frequency of Non-epileptic Involuntary Movements. Hospital-based Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Movement disorders are conventionally divided into major categories: 1) Hyperkinetic movement disorders (also called dyskinesias) refer to excessive, often repetitive, involuntary movements that intrude into the normal flow of motor activity. This category includes chorea, dystonia, myoclonus, stereotypies, tics, and tremor. 2) Hypokinetic movement 3) Ataxia.
Hyperkinetic movements any unwanted excess movement. Together with hypertonia (abnormally increased resistance to externally imposed movement) and negative signs (insufficient muscle activity or insufficient control of muscle activity).
Tremor: Tremor is a rhythmic back-and-forth or oscillating purposeless involuntary movement about a joint axis. Tremor occurs at rest (the pill-rolling tremor of Parkinsonism). Postural tremor (the fine tremor of hyperthyroidism), Action tremor (intention tremor) occurs near the end of a goal-directed movement.
Chorea : is a series of brief, jerky, explosive ongoing random-appearing sequence of one or more discrete involuntary movements, or "fidgeting; there are different causes of chorea, Sydenham's chorea. Lesions in the sub thalamic nucleus. Encephalitis with diffuse gray-matter. Motor impersistence is a common association.
Athetosis is a slow, continuous, writhing, sinuous movement, especially marked in the digits and extremities, prevents maintenance of a stable posture.
Myoclonus consists of sequence of repeated, often non-rhythmic sudden brief twitches or jerks or involuntary contraction or relaxation of one or more muscles as seen in metabolic encephalopathies such as uremic encephalopathy. It can be categorized as "action myoclonus", "postural myoclonus", or "rest myoclonus" based on the condition when it is observed Asterixis :is an intermittency of sustained posture, illustrated by "flapping" of the hands when the arms are outstretched and wrists dorsiflexed, as in hepatic encephalopathy.
Stereotypies are repetitive, simple movements that can be voluntarily suppressed. Stereotypies do not necessarily hold the person's attention.
Tics are repeated, individually recognizable, intermittent movements that are almost always briefly suppressible and are usually associated with awareness of an urge to perform the movement.
Dystonia: a movement disorder in which involuntary sustained or intermittent muscle contractions cause twisting and repetitive movements, abnormal postures, or both. Dystonic postures are often triggered by attempts at voluntary movement or voluntary posture, as may occur in task-specific dystonia.
Hypokinetic movements: include bradykinesia (slowness of movement) and hypokinesia (poverty of movement, and movements that are smaller than intended), but also crucially and fundamentally the progressive fatiguing and decrement of repetitive alternating movements seen during finger or foot tapping. The best known cause and example is Parkinson's disease.
Ataxia: Ataxia is a degenerative disorder affecting the brain, brainstem or spinal cord. This can result in clumsiness, inaccuracy, instability, imbalance, tremor or a lack of coordination while performing voluntary movements. Ataxia also can affect speech and movement of the eyes.
Previous epidemiological studies in Egypt showed that the Overall the recorded Crude Prevalence Rate (CPR) of Parkinson's disease in Egypt was varied in different governorates and ranged from 53 to 557/105 inhabitants Another study was planned to estimate the prevalence and to study the aetiological factors of chorea, dystonia, athetosis and hemiballismus in Assiut. The prevalence rate for rheumatic chorea was 62/100,000 population, whereas Huntington's chorea had a prevalence rate of 21/100,000. The other two common types of chorea were reported with prevalence rates of 12/100,000 for the encephalitic type and 17/100,000 for the atherosclerotic type. No single case of generalized dystonia was recorded and all cases were of the focal type of dystonia with a prevalence rate of 26/100,000 population, but there's no available data about other movement disorders in Egypt
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Assiut, Egypt
- AssiutU
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
Description
Inclusion Criteria:
- Patients with movement disorders attending Assiut University neurology outpatient clinic and internal department, from Jan 2020 to Jan 2021.
Exclusion Criteria:
- 1) involuntary movements epileptic in origin 2) refusal of patient to give consent to join the study
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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•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 Dec15th 2019 to June15th 2020.
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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
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from Dec15th 2019 to June15th 2020.
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•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 Dec15th 2019 to June15th 2020.
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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
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from Dec15th 2019 to June15th 2020.
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•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 Dec15th 2019 to June15th 2020.
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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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from Dec15th 2019 to June15th 2020.
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Collaborators and Investigators
Sponsor
Investigators
- 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 and helpful links
General Publications
- 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. Erratum In: Am J Psychiatry 1998 Apr;155(4):578.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- frequency involuntary movement
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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