Back to resultsWalking in the HIBBOT: is Gait Improved?
Primary Purpose
Cerebral Palsy
Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
HIBBOT
Standard Care
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring gait, biomechanics
Eligibility Criteria
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
Sites / Locations
- University of Antwerp
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hibbot
Standard Care
Arm Description
Outcomes
Primary Outcome Measures
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.
Change in Muscle activation patterns during gait in microvolts
Surface electromyography signals will be recorded during gait
Secondary Outcome Measures
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.
Muscle activation patterns during gait in microvolts
Surface electromyography signals will be recorded during gait
Full Information
NCT ID
NCT04172324
First Posted
November 18, 2019
Last Updated
October 5, 2021
Sponsor
Universiteit Antwerpen
1. Study Identification
Unique Protocol Identification Number
NCT04172324
Brief Title
Walking in the HIBBOT: is Gait Improved?
Official Title
The Effect of a Novel Gait Trainer, the Hibbot, on the Development of Crouch Gait in Children With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
lack of funding
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiteit Antwerpen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
gait, biomechanics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hibbot
Arm Type
Experimental
Arm Title
Standard Care
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
HIBBOT
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Care
Intervention Description
Standard care involves the standard physiotherapy the child would get during clinical care.
Primary Outcome Measure Information:
Title
Change in Lower limb kinematics during walking in degrees
Description
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.
Time Frame
baseline (at intake, T0) and after the intervention period (3 months, T1)
Title
Change in Muscle activation patterns during gait in microvolts
Description
Surface electromyography signals will be recorded during gait
Time Frame
baseline (at intake, T0) and after the intervention period (3 months, T1)
Secondary Outcome Measure Information:
Title
Lower limb kinematics during walking in degrees
Description
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.
Time Frame
at follow up (12 months after intake, T2)
Title
Muscle activation patterns during gait in microvolts
Description
Surface electromyography signals will be recorded during gait
Time Frame
at follow up (12 months after intake, T2)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Antwerp
City
Antwerp
ZIP/Postal Code
2160
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Walking in the HIBBOT: is Gait Improved?
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