Walking in the HIBBOT: is Gait Improved?

NCT04172324 | Terminated

• 1 other identifier: 18/44/509
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

gait; biomechanics

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Lower limb kinematics during walking in degrees

  at follow up (12 months after intake, T2)

• Muscle activation patterns during gait in microvolts

  at follow up (12 months after intake, T2)

Study Arms (2)

Hibbot

EXPERIMENTAL

Device: HIBBOT; Other: Standard Care

Standard Care

ACTIVE COMPARATOR

Other: Standard Care

Interventions

HIBBOT DEVICE

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.

Hibbot

Standard Care OTHER

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

Hibbot; Standard Care

Eligibility Criteria

• Age: 18 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Hip dysplasia
• Fixed contractures in the lower limb
• Insufficient understanding of the interventon and tests (based on mental level assessment)
• Refractary epilepsia

Sponsors & Collaborators

• Universiteit Antwerpen: lead

Study Sites (1)

University of Antwerp

Antwerp, 2160, Belgium

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistent Professor, Research Group MOVANT, Department of Rehabilitation Sciences and Physiotherapy - Head of the Multidisciplinary Motor Center Antwerp

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 21, 2019
• Study Start: October 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: September 30, 2019
• Last Updated: October 14, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: At finalisation of the study and for a period of 5 years
• Access Criteria: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Locations

BE (1)