Walking in the HIBBOT: is Gait Improved?

Universiteit Antwerpen

Status: Terminated

Conditions: Cerebral Palsy

Treatments: Other: Standard Care; Device: HIBBOT

Study type: Interventional

Funder types: Other

Identifiers

NCT04172324

18/44/509

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 months to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Hibbot

Experimental group

Treatment:

Other: Standard Care

Device: HIBBOT

Standard Care

Active Comparator group

Treatment:

Other: Standard Care