Walking in the HIBBOT: is Gait Improved?

Not Applicable

Terminated

• Conditions: Cerebral Palsy
• Interventions: Device: HIBBOT; Other: Standard Care

• Registration Number: NCT04172324
• Lead Sponsor: Universiteit Antwerpen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-01
• Primary Completion: 2019-06-30
• Study Completion: 2019-09-30
• Study First Submitted: 2019-11-18
• Study First Submitted QC: 2019-11-20
• Study First Posted: 2019-11-21
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-05
• Last Update Posted: 2021-10-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hibbot	HIBBOT	-
Hibbot	Standard Care	-
Standard Care	Standard Care	-

Primary Outcome Measures

Name	Time	Method
Change in Lower limb kinematics during walking in degrees	baseline (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 microvolts	baseline (at intake, T0) and after the intervention period (3 months, T1)	Surface electromyography signals will be recorded during gait

Secondary Outcome Measures

Name	Time	Method
Lower limb kinematics during walking in degrees	at 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.
Muscle activation patterns during gait in microvolts	at follow up (12 months after intake, T2)	Surface electromyography signals will be recorded during gait

Trial Locations

Locations (1)

University of Antwerp; 🇧🇪 Antwerp, Belgium