Infantile cerebral palsy
Conditions
Interventions
Trade Name: Botulinumtoxin-A (BOTOX)
Product Name: Botulinumtoxin-A
Product Code: 1-23699
Pharmaceutical Form: Powder and solvent for solution for injection
CAS Number: 93384-43-1
Other descriptive na
Sponsors
Orthopädisches Spital Speising
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosis infantil cerebral palsy Medical advice for BoNT therapy Passive correction of the ankle joint (upper, lower) to 0 degree (0 degree knee joint) age between 6-10 years and GMFCS Level I-II male/female Are the trial subjects under 18? yes Number of subjects for this age range: 40 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Surgical achilles tendon or calf muscle intervention Structural injury within the lower leg Additional orthosis for the leg region Non compliance Athetosis Ataxia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Ankle joint angle at initial contact passive dorsalflexion at the ankle joint maximum dorsiflexion during stance phase;Secondary Objective: Several gait kinematic parameters Walking speed Power generation during push off Wearing time of the orthosis Force needed to reach a passive ankle joint Position of 0 degree (knee joint at 0 degree and 90 degree) Passive dorsiflexion of the ankle joint at knee;Primary end point(s): Flat foot or heel contact during initial contact in gait;Timepoint(s) of evaluation of this end point: 16 weeks, 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): after 16 weeks still initial contact with forefoot ;Timepoint(s) of evaluation of this end point: 16 weeks | — |
Countries
Austria
Contacts
Public ContactRobert Csepan
Orthopädisches Spital Speising
Outcome results
None listed