Functional Electrical Stimulation During Walking in Cerebral Palsy
Cerebral Palsy, Spastic, Foot Drop
About this trial
This is an interventional treatment trial for Cerebral Palsy
Eligibility Criteria
Inclusion Criteria:
- Unilateral foot drop of central origin, particularly the absence of initial heel contact
- Participants are currently treated with ankle-foot orthoses or (adapted) shoes to wear on a daily basis
- Participants ambulate independently, and thus classified as Gross Motor Function Classification System (GMFCS) levels I or II and have a gait type 1 according to Winters et al (4).
- Participants are able to walk for at least 15 minutes
- Confirmed cerebral abnormality with MRI (showing medial infarction, maldevelopment of the brain, or porencephaly).
- Participants are aged 4-18 years at time of inclusion
Exclusion Criteria:
- Plantarflexion ankle contracture of more than 5 degrees plantarflexion with the knee extended
- Botulinum toxin A injection to the plantar or dorsiflexor muscle groups within the 6 months before the study
- Orthopaedic surgery to the legs in the previous year
- Uncontrolled epilepsy with daily seizures
Sites / Locations
- Maastricht University Medical Center
Arms of the Study
Arm 1
Arm 2
Other
Other
FES start
Conventional start
Start: 4 weeks 'adaptation phase' and 8 weeks 'FES phase'. Adaption phase: the stimulus (in Volt) will gradually be increased up to an effective level and the wear time has to be increased from 30 minutes to 6 hours a day. FES phase: the participants have to wear the FES device for minimal 6 hours a day during walking. Usual physiotherapy can be continued during the FES phase. Second: after the FES phase, this group will enter the 'wash-out' period of 6 weeks for fading of the therapeutic effects, in which they return to their conventional therapy. Afterwards, 12 weeks of conventional therapy (orthoses/shoes and usual physiotherapy) with measurements at start and end will follow.
Start: wearing usual orthoses/shoes on a daily basis for the first 12 weeks of the study. Usual physiotherapy can be continued. Second: after 12 weeks this group will enter a 6 week watch out phase, and next be switched to FES treatment for 12 weeks, consisting of: 4 weeks 'adaptation phase' with gradual increase of the treatment and 8 weeks 'FES phase'.