infantile encephalopathy spastic paresis
Conditions
Interventions
Current (control) treatment: Individuals suffering from stroke and other
neurological disorders often experience inadequate dorsiflexion during swing
phase of the gait cycle due to dorsiflexor muscl
for instance whether they have properly aligned and fitted
orthoses and shoes. If the orthosis or shoes are not well fitting, we will
first adjust and optimize this before starting the trial. We wil
Innovative Neurotronics,
Austin, Texas, USA) delivers asymmetrical biphasic surface electrical
stimulation to the common fibular (formerly common peroneal) nerve, triggered
by an individually progr
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
2 Years to 17 Years
Inclusion 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 - 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participation level: Do patients achieve individual goals, measured by the goal-attainment-scale (GAS)? What do patients gain at the levels of activities and participation at the long term (3 years), measured using the Canadian Occupational Performance Measure (COPM)? | — |
Secondary
| Measure | Time frame |
|---|---|
| Activity level: • Does FES increase the walking distance? For this purpose we will perform a 6-minute walking test in CAREN, during both the FES and the control phase. (6) Besides that, we will use the functional mobility scale(FMS), which includes a classification of the functional mobility (1-5) and walking distance. Furthermore we will use two activity measurement devices to estimate the number of steps during 7 days at three study points (1 week before start treatment, after 3 months and at 6 months). • Does FES have a positive effect on falls/near falls? We will provide a questionnaire about falling a three time points (1 week before start treatment, after 3 months and at 6 months). • Does FES improve the stability during sustained (10-15 minutes) walking? Function level: • Does FES improve ankle dorsal flexion and toe clearance? Using the gait analysis we will evaluate the ankle dorsal flexion and toe clearance using a specially developed analysis program, which allows automatic detection without user interference. • Does the use of FES influence ankle plantar flexion force of the calf muscles during gait? For this purpose we will use the gait analysis data to calculate net moments of push off during gait. • Does the use of FES modulate the force of the dorsiflexors and plantar flexors of the foot (i.e anterior tibial muscle and fibular muscles)?. For this purpose we measure strength using the Jamar hydrolic hand dynamometer. Output will be provided in kilograms (range 0.0-90 kg; sensitivity 0.1kg). The position of the dynamometer was will be standardized for each measurement. The tester will be setting a constant resistive force for 3 to 5 seconds, directed perpendicular to the long axis of the limb segment to elicit an isometric muscle contraction. A standard instruction of *push as hard as you can* was will be given to each participant for each trial. Ankle plantar flexors: Supine Knee extended and foot held in plantigrade posi | — |
Countries
Netherlands
Outcome results
None listed