A prospective placebo controlled study of botulilium toxin (BOTOX) on gait disorder induced by spastic equinovarus foot.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-004685-17-BE

Enrollment

Registered

2006-01-31

Start date

2005-11-16

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spastic equinus foot is a common dynamic deformity in patients with cerebral palsy. This dynamic deformity, mainly caused by spasticity of the soleus, gastrocnemius and tibialis posterior muscles, may lead to gait impairment.

Interventions

Trade Name: BOTOX Product Name: BOTOX Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Botox Concentration unit: IU/ml international unit(s)/millilitre Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients will have unilateral spastic hemiplegia due to vascular or traumatic brain injury, with spastic drop foot impairing gait. Moreover, each patient will be included in a functional rehabilitation program (3 to 5 sessions/week of physiotherapy) during the study. The inclusion criteria are : ? Unilateral clinical symptoms ? Equinus foot without fixed contracture ? Cerebral lesion superior to 2 months ? Independent gait with or without orthesis Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: The exclusion criteria are : ? Absence of prior orthopedic surgery in the lower extremities ? Absence of major cognitive disorders (MMS > 24) ? Absence of others factors interfering with gait as judged by investigators

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective is to assess the analytical and functional effects of Botox injected into the muscles of the calf on patients with gait impairment due to spastic equinus foot.;Secondary Objective: The secondary objective is to do an accurate analysis of the gait of patients with gait impairment due to spastic equinus foot. ;Primary end point(s): The primary endpoints are to analyse, on patients with gait impairment due to spastic equinus foot, the effects of Botox on calf spasticity and on gait (temporospatial parameters, kinematic parameters of ankle, auto-assessment index of gait quality). The secondary endpoints are to analyse, on patients with gait impairment due to spastic equinus foot, the effects of Botox on kinematic parameters of knee and hip during gait, kinetic parameters during gait and static balance in standing position.	—

Measure

Time frame

Main Objective: The main objective is to assess the analytical and functional effects of Botox injected into the muscles of the calf on patients with gait impairment due to spastic equinus foot.;Secondary Objective: The secondary objective is to do an accurate analysis of the gait of patients with gait impairment due to spastic equinus foot. ;Primary end point(s): The primary endpoints are to analyse, on patients with gait impairment due to spastic equinus foot, the effects of Botox on calf spasticity and on gait (temporospatial parameters, kinematic parameters of ankle, auto-assessment index of gait quality). The secondary endpoints are to analyse, on patients with gait impairment due to spastic equinus foot, the effects of Botox on kinematic parameters of knee and hip during gait, kinetic parameters during gait and static balance in standing position.

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Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026