Cerebral PalsyNCT04172324
Walking in the HIBBOT: is Gait Improved?
A study testing HIBBOT in people with Cerebral Palsy, run by Universiteit Antwerpen at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 months to 6 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- HIBBOT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2018to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cerebral Palsy
- Being tested
- HIBBOT, Standard Care
- Keywords
- gait, biomechanics
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIBBOTDevice
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.
Standard CareOther
Standard care involves the standard physiotherapy the child would get during clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Hibbot | Experimental | Not described Receives: Device: HIBBOT; Other: Standard Care |
| Standard Care | Active comparator | Not described Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: baseline (at intake, T0) and after the intervention period (3 months, T1)
Secondary outcomes (2)
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.
Measured: at follow up (12 months after intake, T2)
Muscle activation patterns during gait in microvolts
Surface electromyography signals will be recorded during gait
Measured: at follow up (12 months after intake, T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start1 Oct 2018
- Primary completion30 Jun 2019
- Study completion30 Sep 2019
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ann Hallemans, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172324
- Sponsor's protocol ID
- 18/44/509
- Status last verified
- Oct 2021
- First submitted
- 18 Nov 2019
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Novel Gait Trainer, the Hibbot, on the Development of Crouch Gait in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04172324
- Acronym / sponsor ID
- 18/44/509
- Conditions
- Cerebral Palsy
- Keywords
- gait, biomechanics
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of funding
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 21 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hibbot | Experimental | Device: HIBBOT, Other: Standard Care |
| Standard Care | Active comparator | Other: Standard Care |
Who may qualify
- Ages
- 18 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIBBOTHibbot 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. | Device | Hibbot |
| Standard CareStandard care involves the standard physiotherapy the child would get during clinical care. | Other | Hibbot, Standard Care |
Primary outcome
Change in Lower limb kinematics during walking in degrees
Time frame: 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
Time frame: baseline (at intake, T0) and after the intervention period (3 months, T1)
Surface electromyography signals will be recorded during gait
2 secondary outcomes
Lower limb kinematics during walking in degrees
Time frame: at follow up (12 months after intake, T2)
Muscle activation patterns during gait in microvolts
Time frame: at follow up (12 months after intake, T2)
Results and safety
The study was stopped early (reason given: lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Individual participant dataSharing planned: Yes. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIBBOT in people with Cerebral Palsy, run by Universiteit Antwerpen at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: lack of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Lower limb kinematics during walking in degrees (time frame: baseline (at intake, T0) and after the intervention period (3 months, T1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021.