Functional evaluation of two therapy concepts: dynamic orthoses and BoNT
Phase 1
- Conditions
- Infantile cerebral palsyTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2013-002896-17-AT
- Lead Sponsor
- Orthopädisches Spital Speising
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
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
Surgical achilles tendon or calf muscle intervention
Structural injury within the lower leg
Additional orthosis for the leg region
Non compliance
Athetosis
Ataxia
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Ankle joint angle at initial contact<br>passive dorsalflexion at the ankle joint<br>maximum dorsiflexion during stance phase;Secondary Objective: Several gait kinematic parameters<br>Walking speed<br>Power generation during push off<br>Wearing time of the orthosis<br>Force needed to reach a passive ankle joint<br>Position of 0 degree (knee joint at 0 degree and 90 degree)<br>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 Outcome Measures
Name Time Method Secondary end point(s): after 16 weeks still<br>initial contact with forefoot<br>;Timepoint(s) of evaluation of this end point: 16 weeks