Walking in the HIBBOT: is Gait Improved?

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04172324
• Other study ID #: 18/44/509
• Status: Terminated
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: October 2021
• Source: Universiteit Antwerpen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: September 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Device:
• HIBBOT
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.

Other:
• Standard Care
Standard care involves the standard physiotherapy the child would get during clinical care.

Locations

Country	Name	City	State
Belgium	University of Antwerp	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	Muscle activation patterns during gait in microvolts	Surface electromyography signals will be recorded during gait	at follow up (12 months after intake, T2)