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

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 Overview

• Status: Terminated
• Conditions: Cerebral Palsy
• Intervention / Treatment: Device: HIBBOT; Other: Standard Care

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium, 2160
    • University of Antwerp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Care	Other: Standard Care; Standard care involves the standard physiotherapy the child would get during clinical care.
Experimental: Hibbot	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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Universiteit Antwerpen

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: November 18, 2019
• First Submitted That Met QC Criteria: November 20, 2019
• First Posted (Actual): November 21, 2019

Study Record Updates

• Last Update Posted (Actual): October 14, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: gait; biomechanics
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 18/44/509

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
• IPD Sharing Time Frame: At finalisation of the study and for a period of 5 years
• IPD Sharing Access Criteria: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
• IPD Sharing Supporting Information Type: ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No