Walking in the HIBBOT: is Gait Improved?

Study Overview
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Brief Summary
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The aim of the study is to assess the impact of the innovative walking aid HIBBOT on the functions, activity and participation of young children with Cerebral Palsy, in comparison with conventional walking aids.

Official Title
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The Effect of a Novel Gait Trainer, the Hibbot, on the Development of Crouch Gait in Children With Cerebral Palsy

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Device: HIBBOT
* Other: Standard Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At risk of or diagnosed with cerebral palsy, based on MRI (uCP 86 - 89 % sensitivity) or HINE (uCP 98% ) or standard motor assessment age 18 months - 6 years GMFCS level II - IV =with potential (=able to stand and walk when supported by a therapist at the level of the pelvis and lower trunk) Sufficient cooperation to complete the tests. Exclusion Criteria: Hip dysplasia Fixed contractures in the lower limb Botox infiltration < 6 months prior to inclusion Surgery < 12 months prior to inclusion Insufficient understanding of the interventon and tests (based on mental level assessment) Refractary epilepsia

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hibbot<br> | Device: HIBBOT<br>* Hibbot is an assistive mechanical device, lightweight and portable. The mechanism of the Hibbot manages to control all degrees of freedom (3x rotation and 3x translation) at the level of the pelvis and lower trunk. The goal is to maximize a child's own muscle activity and postural control while giving as minimal support as needed.<br>Other: Standard Care<br>* Standard care involves the standard physiotherapy the child would get during clinical care.<br>|
| Active Comparator: Standard Care<br> | Other: Standard Care<br>* Standard care involves the standard physiotherapy the child would get during clinical care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Lower limb kinematics during walking in degrees | The gait pattern is assessed by instrumented 3D gait analysis. Joint rotation angles of the major joints of the lower limbs will be described during walking. | baseline (at intake, T0) and after the intervention period (3 months, T1) | 
| Change in Muscle activation patterns during gait in microvolts | Surface electromyography signals will be recorded during gait | baseline (at intake, T0) and after the intervention period (3 months, T1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower limb kinematics during walking in degrees | The gait pattern is assessed by instrumented 3D gait analysis. Joint rotation angles of the major joints of the lower limbs will be described during walking. | at follow up (12 months after intake, T2) | 
| Muscle activation patterns during gait in microvolts | Surface electromyography signals will be recorded during gait | at follow up (12 months after intake, T2) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gait, biomechanics