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Treatment of Gait Disorders in Children With Dravet Syndrome (T-GaiD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03857451
Recruitment Status : Active, not recruiting
First Posted : February 28, 2019
Last Update Posted : January 21, 2020
Sponsor:
Collaborators:
University Hospital, Antwerp
KU Leuven
Universitaire Ziekenhuizen Leuven
Research Foundation Flanders
Information provided by (Responsible Party):
Ann Hallemans, Universiteit Antwerpen

Brief Summary:
Dravet syndrome is a severe infantile onset epilepsy syndrome with a prevalence of 1/15.000 to 1/30.000. An infant with an apparently normal development presents around 6 months of age with a convulsive status epilepticus. Seizures can be triggered by fever, illness or vaccination. Because of its drug-resistance, in the past, most attention has been paid to seizure control. However, developmental and behavioural problems also become a serious concern during the second year of life. Outcome is poor, with intellectual disability and ongoing seizures. On the long term, the deterioration in gait is very characteristic. A crouch gait pattern develops that largely impacts the daily life functioning. Most children maintain the ability to walk around the house, but for longer distances they must rely on wheelchair use, which further negatively affects their mobility. Gait analysis, when combined with physical examination, provides quantitative information to guide treatment of gait disorders and assess its outcome. The goal of this project is the development of a clinical decision framework based upon 3D gait analysis to diagnose and treat mobility problems in children with Dravet syndrome. Two major university hospitals in Flanders (UZA and UZ Leuven) are partners in this project. The parent organisation "Stichting Dravetsyndroom Nederland/Vlaanderen" will also participate, as intermediate partner to facilitate contacts between all parties being patients and their caregivers, clinical gait labs and treating physicians.

Condition or disease Intervention/treatment
Dravet Syndrome Severe Myoclonic Epilepsy of Infancy Diagnostic Test: Clinical gait analysis

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment of Gait Disorders in Children With Dravet Syndrome
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020



Intervention Details:
  • Diagnostic Test: Clinical gait analysis
    Three dimensional gait analysis consisting of joint kinematics, kinetics and dynamic EMG data will be introduced into the diagnostic scheme


Primary Outcome Measures :
  1. Lower limb kinematics during walking in degrees [ Time Frame: baseline (at intake in year 1 of the study, T0) ]
    The gait pattern is assessed by instrumented 3D gait analysis using the standardized Vicon Clinical Gait Model. Joint rotation angles of the major joints of the lower limbs will be described during walking


Secondary Outcome Measures :
  1. Lower limb kinematics during walking in degrees [ Time Frame: after 12 months (T1), after 24 months (T2) and after 36 months (T3) from intake ]
    The gait pattern is assessed by instrumented 3D gait analysis using the standardized Vicon Clinical Gait Model. Joint rotation angles of the major joints of the lower limbs will be described during walking.

  2. Lower limb kinetics during walking [ Time Frame: baseline (at intake in year 1 of the study, T0), after 12 months (T1), after 24 months (T2) and after 36 months (T3) from intake ]
    The gait pattern is assessed by instrumented 3D gait analysis using the standardized Vicon Clinical Gait Model. Net forces acting around the major joints of the lower limbs will be calculated.

  3. Muscle activation patterns during gait in microvolts [ Time Frame: baseline (at intake in year 1 of the study, T0), after 12 months (T1), after 24 months (T2) and after 36 months (T3) from intake ]
    Surface electromyography signals (microvolts) will be recorded during gait.

  4. Functional strength on the Functional Strength Measurement. [ Time Frame: baseline (at intake in year 1 of the study, T0), after 12 months (T1), after 24 months (T2) and after 36 months (T3) from intake ]
    Functional muscle strength will be assessed during clinical examination using the Functional Strength Measurement (FSM). The FSM consists of eight items: overarm throwing (centimeters), chest pass (centimeters), standing long jump (centimeters), sit to stand (number of repetitions in 30 seconds), underarm throwing (centimeters), lifting a box (number of repetitions in 30 seconds), lateral step-up (numer of repetitions in 30 seconds) and stair climbing (number of steps in 30 seconds). Norm reference values are available.

  5. Functional Mobility Scale [ Time Frame: baseline (at intake in year 1 of the study, T0), after 12 months (T1), after 24 months (T2) and after 36 months (T3) from intake ]
    Functional mobility will be assessed during parent interview using the Functional Mobility Scale (FMS). The FMS is a 6-point scale with maximum score of 6 being the most functional outcome (independent on all surfaces) and minimum score of 1 being the least functional outcome (uses wheelchair)

  6. Mobility Questionnaire 28 [ Time Frame: baseline (at intake in year 1 of the study, T0), after 12 months (T1), after 24 months (T2) and after 36 months (T3) from intake ]
    Mobility limitations during daily activities inside and outside of the house will be assessed during parent interview using the validated Dutch translation of the Mobility Questionnaire 28 (MobQuest28), Dutch version: MobiliteitsVragenlijst 28 (MoVra28). The MobQuest28/MoVra28 consists of 28 items with a 5-point rating scale (0 = without any difficulties to 4 = impossible without help). A total score (0-100) indicates the mobility limitations.


Other Outcome Measures:
  1. heigth in meters [ Time Frame: baseline (at intake in year 1 of the study, T0), after 12 months (T1), after 24 months (T2) and after 36 months (T3) from intake ]
    Total body height will be measured during clinical examination

  2. body weigth in kilogram [ Time Frame: baseline (at intake in year 1 of the study, T0), after 12 months (T1), after 24 months (T2) and after 36 months (T3) from intake ]
    Body weight will be measured during clinical examination

  3. passive joint range of motion in degrees [ Time Frame: baseline (at intake in year 1 of the study, T0), after 12 months (T1), after 24 months (T2) and after 36 months (T3) from intake ]
    Passive joint range of motion (°) will be measured during clinical examination using a goniometer

  4. skeletal alignment in degrees [ Time Frame: baseline (at intake in year 1 of the study, T0), after 12 months (T1), after 24 months (T2) and after 36 months (T3) from intake ]
    Skeletal alignment will be measured during clinical examination using a goniometer

  5. Muscle length in degrees [ Time Frame: baseline (at intake in year 1 of the study, T0), after 12 months (T1), after 24 months (T2) and after 36 months (T3) from intake ]
    Hamstrings length (popliteal angle in degrees) and iliopsoas length (Thomas test in degrees) will be measured during clinical examination using a goniometer

  6. Selective muscle strength on the Medical Research Council muscle scale [ Time Frame: baseline (at intake in year 1 of the study, T0), after 12 months (T1), after 24 months (T2) and after 36 months (T3) from intake ]
    The Medical Research Council muscle scale is a 6-point scale with minimum score 0 = no muscle contraction and maximum score 5 = normal muscle power.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All children and adolescents with Dravet syndrome living in Flanders and the Netherlands
Criteria

Inclusion Criteria:

  • diagnosed with Dravet syndrome according to the criteria of Ceulemans and Cras (2004)
  • aged minimum 3 years and maximum 25 years at inclusion
  • having minimum 1 year of walking experience

Exclusion Criteria:

  • severe epileptic seizure (status epilepticus or tonic-clonic insult over 3 min) within the 24 hours before the assessment
  • insufficient cooperation to perform 3D gait analysis
  • comorbidities of other neurological and/or orthopedic disorders not linked to Dravet syndrome

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): NCT03857451


Locations
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Belgium
University Hospital Antwerp
Antwerp, Belgium, 2160
University of Antwerp
Antwerp, Belgium, 2160
KU Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Universiteit Antwerpen
University Hospital, Antwerp
KU Leuven
Universitaire Ziekenhuizen Leuven
Research Foundation Flanders
Investigators
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Principal Investigator: Ann Hallemans, PhD Rehabilitation Sciences and Physiotherapy, University of Antwerp
  Study Documents (Full-Text)

Documents provided by Ann Hallemans, Universiteit Antwerpen:
Informed Consent Form  [PDF] March 29, 2019
Study Protocol  [PDF] February 7, 2017

Publications:
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Responsible Party: Ann Hallemans, Assistent Professor, Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Science, Head of the Multidisciplinary Motor Center Antwerp, Universiteit Antwerpen
ClinicalTrials.gov Identifier: NCT03857451    
Other Study ID Numbers: 34264
T003116N ( Other Grant/Funding Number: Research Foundation - Flanders )
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: January 21, 2020
Last Verified: January 2020
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
Keywords provided by Ann Hallemans, Universiteit Antwerpen:
Dravet syndrome
severe myoclonic epilepsy of infancy
intellectual disabilities
movement disorders
gait
biomechanics
Additional relevant MeSH terms:
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Epilepsy
Epilepsies, Myoclonic
Syndrome
Disease
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epilepsy, Generalized
Epileptic Syndromes