Treatment of Gait Disorders in Children With Dravet Syndrome (T-GaiD)
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ClinicalTrials.gov Identifier: NCT03857451 |
Recruitment Status :
Completed
First Posted : February 28, 2019
Last Update Posted : April 14, 2022
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Condition or disease | Intervention/treatment |
---|---|
Dravet Syndrome Severe Myoclonic Epilepsy of Infancy | Diagnostic Test: Clinical gait analysis |

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 |
Actual Study Completion Date : | December 31, 2020 |

- 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
- 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
- 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.
- 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.
- 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.
- 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.
- 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)
- 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.
- 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
- 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
- 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
- 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
- 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
- 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.

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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 |
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

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
Belgium | |
University Hospital Antwerp | |
Antwerp, Belgium, 2160 | |
University of Antwerp | |
Antwerp, Belgium, 2160 | |
KU Leuven | |
Leuven, Belgium, 3000 |
Principal Investigator: | Ann Hallemans, PhD | Rehabilitation Sciences and Physiotherapy, University of Antwerp |
Documents provided by Ann Hallemans, Universiteit Antwerpen:
Other Publications:
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: | April 14, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Dravet syndrome severe myoclonic epilepsy of infancy intellectual disabilities |
movement disorders gait biomechanics |
Epilepsy Epilepsies, Myoclonic Syndrome Disease Pathologic Processes |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Epilepsy, Generalized Epileptic Syndromes |