Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04172324
Other study ID # 18/44/509
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
See also
  Status Clinical Trial Phase
Recruiting NCT05317234 - Genetic Predisposition in Cerebral Palsy N/A
Recruiting NCT05576948 - Natural History of Cerebral Palsy Prospective Study
Completed NCT04119063 - Evaluating Wearable Robotic Assistance on Gait Early Phase 1
Completed NCT03264339 - The Small Step Program - Early Intervention for Children With High Risk of Developing Cerebral Palsy N/A
Completed NCT05551364 - Usability and Effectiveness of the ATLAS2030 Exoskeleton in Children With Cerebral Palsy N/A
Completed NCT03902886 - Independent Walking Onset of Children With Cerebral Palsy
Recruiting NCT05571033 - Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy N/A
Not yet recruiting NCT04081675 - Compliance in Children With Cerebral Palsy Supplied With AFOs
Completed NCT02167022 - Intense Physiotherapies to Improve Function in Young Children With Cerebral Palsy N/A
Completed NCT04012125 - The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy N/A
Enrolling by invitation NCT05619211 - Piloting Movement-to-Music With Arm-based Sprint-Intensity Interval Training Among Children With Physical Disabilities Phase 1
Completed NCT04489498 - Comparison of Somatometric Characteristics Between Cerebral Palsy and Normal Children, Cross-sectional, Multi Center Study
Completed NCT03677193 - Biofeedback-enhanced Interactive Computer-play for Youth With Cerebral Palsy N/A
Recruiting NCT06450158 - Robot-assisted Training in Children With CP N/A
Completed NCT04093180 - Intensive Neurorehabilitation for Cerebral Palsy N/A
Completed NCT02909127 - The Pediatric Eating Assessment Tool
Not yet recruiting NCT06377982 - Human Umbilical Cord Blood Infusion in Patients With Cerebral Palsy Phase 1
Not yet recruiting NCT06007885 - Examining Capacity Building of Youth With Physical Disabilities to Pursue Participation Following the PREP Intervention. N/A
Not yet recruiting NCT03183427 - Corpus Callosum Size in Patients With Pineal Cyst N/A
Active, not recruiting NCT03078621 - Bone Marrow-Derived Stem Cell Transplantation for the Treatment of Cerebral Palsy Phase 1/Phase 2