Treatment of gait problems caused by spastic tightening of the calf muscles in children with cerebral palsy. A randomized, placebo controlled Botulinum toxin type A volume/response study.

Treatment of equinus gait caused by dynamic tightening of the calf muscles in children with cerebral palsy. A randomized, placebo controlled Botulinum toxin type A volume/response study.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004474-42-DK

Enrollment

Registered

2015-03-11

Start date

2015-05-07

Completion date

Unknown

Last updated

2017-10-30

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

Conditions

Treatment of equinus gait caused by dynamic tightening of the calf muscles in children with cerebral palsy. MedDRA version: 18.0 Level: LLT Classification code 10015112 Term: Equinus deformity of foot, acquired System Organ Class: 100000004859

Interventions

Trade Name: BOTOX® (onabotulinumtoxinA) Product Name: BOTOX® (onabotulinumtoxinA) Pharmaceutical Form: Injection INN or Proposed INN: Botulinum toxin A Other descriptive name: BOTULINUM TOXIN A - HAEM

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Spastic cerebral palsy diagnosed by a neuro-pediatrician - Spasticity/increased tone in m. triceps surae - 3-8 years of age - GMFCS level I or II Are the trial subjects under 18? yes Number of subjects for this age range: 26 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: Lacking ability to cooperate and take part in three-dimensional gait analysis - More than five previous BoNT-A treatments or insufficient effect of the latest treatment - Hypersensitivity caused by BoNT-A or one or more of the ancillary substances - Infection at the intended injection site - Injection treatment with BoNT-A within the previous four months - Operations in the lower extremities within the previous year - Planned operations in the lower extremities, that is deemed to interfere with research outcome parametres during the project period

Design outcomes

Primary

Measure	Time frame
Main Objective: To examine how two different volumes of botox in the triceps surae (mm. gastrocnemii lateralis et medialis and if necessary m. soleus) affect the efficacy of the treatment compared to placebo measured by improved gait function (three dimensional gait analysis).;Secondary Objective: Non applicable.;Primary end point(s): Three-dimensional gait analysis: - Maximum dorsiflexion in the ankle joint during stance ;Timepoint(s) of evaluation of this end point: 1: 1-2 weeks before first injection 2: 4-6 weeks after first injection 3: 1-2 weeks before second injection 4: 4-6 weeks after second injection 5: 1-2 weeks before third injection 6: 4-6 weeks after third injection	—

Measure

Time frame

Main Objective: To examine how two different volumes of botox in the triceps surae (mm. gastrocnemii lateralis et medialis and if necessary m. soleus) affect the efficacy of the treatment compared to placebo measured by improved gait function (three dimensional gait analysis).;Secondary Objective: Non applicable.;Primary end point(s): Three-dimensional gait analysis: - Maximum dorsiflexion in the ankle joint during stance ;Timepoint(s) of evaluation of this end point: 1: 1-2 weeks before first injection 2: 4-6 weeks after first injection 3: 1-2 weeks before second injection 4: 4-6 weeks after second injection 5: 1-2 weeks before third injection 6: 4-6 weeks after third injection

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Secondary

Measure	Time frame
Secondary end point(s): Three-dimensional gait analysis: - Maximum gastrocnemius length - Changes in external knee extension and internal ankle plantarflexor moments - Walking speed, step length, symmetry Others: - Foot function (pedobarography) - Muscle activity (EMG) - PROM/AROM (ankle, knee and hip joints) - Spasticity (modified Ashworth, Portable Spasticity Assessment Device*) - Gross Motor Function Measure, dimension D & E. - Pediatric Evaluation of Disability Inventory (PEDI) - Muscle volume/thickness (m. gastrocnemius and m. soleus) measured by ultrasound before each injection.;Timepoint(s) of evaluation of this end point: 1: 1-2 weeks before first injection 2: 4-6 weeks after first injection 3: 1-2 weeks before second injection 4: 4-6 weeks after second injection 5: 1-2 weeks before third injection 6: 4-6 weeks after third injection - Muscle volume/thickness (m. gastrocnemius and m. soleus) will be measured by ultrasound before each injection. The measurement will be performed with reference to the anatomical levels described by Berweck et Heinen (2005).	—

Measure

Time frame

Secondary end point(s): Three-dimensional gait analysis: - Maximum gastrocnemius length - Changes in external knee extension and internal ankle plantarflexor moments - Walking speed, step length, symmetry Others: - Foot function (pedobarography) - Muscle activity (EMG) - PROM/AROM (ankle, knee and hip joints) - Spasticity (modified Ashworth, Portable Spasticity Assessment Device*) - Gross Motor Function Measure, dimension D & E. - Pediatric Evaluation of Disability Inventory (PEDI) - Muscle volume/thickness (m. gastrocnemius and m. soleus) measured by ultrasound before each injection.;Timepoint(s) of evaluation of this end point: 1: 1-2 weeks before first injection 2: 4-6 weeks after first injection 3: 1-2 weeks before second injection 4: 4-6 weeks after second injection 5: 1-2 weeks before third injection 6: 4-6 weeks after third injection - Muscle volume/thickness (m. gastrocnemius and m. soleus) will be measured by ultrasound before each injection. The measurement will be performed with reference to the anatomical levels described by Berweck et Heinen (2005).

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Countries

Denmark

Contacts

Public ContactChristian Wong

Copenhagen University Hospital Hvidovre

chwoforsk@gmail.com004538826966

Outcome results

None listed

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