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Functional electrical stimulation of the ankle dorsiflexors during walking in children with unilateral spastic cerebral palsy: a randomized crossover intervention study.

Phase 4
Recruiting
Conditions
infantile encephalopathy
spastic paresis
10010335
Registration Number
NL-OMON55409
Lead Sponsor
Medisch Universitair Ziekenhuis Maastricht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
25
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
- In the case that more than 3 dropouts occur, more than 25 patients will be
included, in order to have at least 22 patients finishing the study.

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Participation level:<br /><br>Do patients achieve individual goals, measured by the goal-attainment-scale<br /><br>(GAS)?<br /><br>What do patients gain at the levels of activities and participation at the long<br /><br>term (3 years), measured using the Canadian Occupational Performance Measure<br /><br>(COPM)? </p><br>
Secondary Outcome Measures
NameTimeMethod
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