TerminatedNot Applicable

Walking in the HIBBOT: is Gait Improved?

Stopped: lack of funding

Belgium10 participantsStarted 2018-10-01

Plain-language 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.

Who can participate

Age range

18 Months – 6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Lower limb kinematics during walking in degrees

Timeframe: baseline (at intake, T0) and after the intervention period (3 months, T1)

Change in Muscle activation patterns during gait in microvolts

Timeframe: baseline (at intake, T0) and after the intervention period (3 months, T1)

Trial details

NCT IDNCT04172324

SponsorUniversiteit Antwerpen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-06-30

View on ClinicalTrials.gov More Cerebral Palsy trials

Who can participate

Age range

18 Months – 6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.