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Walking in the HIBBOT: is Gait Improved?

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04172324
Enrollment
10
Registered
2019-11-21
Start date
2018-10-01
Completion date
2019-09-30
Last updated
2021-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy

Keywords

gait, biomechanics

Brief summary

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.

Interventions

DEVICEHIBBOT

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.

OTHERStandard Care

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

Sponsors

Universiteit Antwerpen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Months to 6 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Lower limb kinematics during walking in degreesbaseline (at intake, T0) and after the intervention period (3 months, T1)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.
Change in Muscle activation patterns during gait in microvoltsbaseline (at intake, T0) and after the intervention period (3 months, T1)Surface electromyography signals will be recorded during gait

Secondary

MeasureTime frameDescription
Muscle activation patterns during gait in microvoltsat follow up (12 months after intake, T2)Surface electromyography signals will be recorded during gait
Lower limb kinematics during walking in degreesat follow up (12 months after intake, T2)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.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026