E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Infantile cerebral palsy |
Infantile Zerebral Parese |
|
E.1.1.1 | Medical condition in easily understood language |
Infantile cerebral palsy |
Infantile Zerebral Parese |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Ankle joint angle at initial contact
passive dorsalflexion at the ankle joint
maximum dorsiflexion during stance phase |
Sprunggelenkswinkel beim initialen Bodenkontakt
Passive Dorsalflexion im oberen Sprunggelenk
Sprunggelenkswinkel in der Standphase - max. Dorsalflexion |
|
E.2.2 | Secondary objectives of the trial |
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 |
Weitere kinematische und kinetische Parameter aus der Ganganalyse
Ganggeschwindigkeit
Abdruckleistung im Sprunggelenk
Tragedauer der Orthese
Passive Dorsalextension auf 0 Grad mit Kraftsensor in Newton (N), sowohl in 0 Grad und 90 Grad Knieflexion. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
Diagnose einer Infantile Zerebralparese (ICP)
Fachärztliche Verordnung zur Behandlung Botulinumtoxin und Unterschenkelgipsen (Gruppe B)
Passive Korrigierbarkeit im oberen Sprunggelenk (OSG) und Subtalargelenk auf Neutral-Null-Stellung bei gestrecktem Kniegelenk
Patienten der Altersgruppe von 6 bis 10 Jahren GMFCS Level I – II (muss selbstständig gehfähig sein)
männlich/weiblich
|
|
E.4 | Principal 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 |
Zustand nach Eingriffen im Bereich der Achillessehne sowie im Wadenmuskel
Strukturelle Schäden (Knorpel und Knochen) im zu therapierenden Bereich
Parallel versorgt mit anderen Unterschenkel Orthesen
Non Compliance
Athetose
Ataxie |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Flat foot or heel contact during initial contact in gait |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
after 16 weeks still
initial contact with forefoot
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |