Walking in the HIBBOT: is Gait Improved?

Universiteit Antwerpen10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cerebral Palsy

Interventions

HIBBOTDEVICE

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.

Standard CareOTHER

Standard care involves the standard physiotherapy the child would get during clinical care.

Eligibility

Sex: ALLMin age: 18 MonthsMax age: 6 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Antwerp

Antwerp, Belgium

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: baseline (at intake, T0) and after the intervention period (3 months, T1)

Secondary Outcomes

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.

Time frame: at follow up (12 months after intake, T2)

Muscle activation patterns during gait in microvolts

Surface electromyography signals will be recorded during gait

Time frame: at follow up (12 months after intake, T2)

Data from ClinicalTrials.gov

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