Treatment of Spastic Equinovarus Foot After Stroke

Treatment of Spastic Equinovarus Foot After Stroke. Efficacy: Association Between Ankle Foot Orthosis and Botulinum Toxin A (BTA) Injection

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00199589

Enrollment

Registered

2005-09-20

Start date

2002-10-31

Completion date

2007-12-31

Last updated

2008-12-30

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

Conditions

Spastic Equinovarus

Keywords

Spastic equinovarus, Botox, Ankle foot orthosis

Brief summary

This study evaluates treatment for spastic foot after stroke using ankle foot orthosis with or without selective injection of BTA (Botox).

Detailed description

This prospective, multicentric open trial evaluates the efficacy of a combined treatment for spastic foot after stroke using ankle foot orthosis with or without selective injection of BTA (Botox) into the tibialis anterior and/or posterior and/or the long toe flexor, and/or medial and lateral gastrocnemius, and/or soleus muscles \[300 BTA U per injection (Botox - Allergan), diluted with saline to a concentration of 5U/0,1 mL, with electromyography guided injection\]. The patients are followed for one year after treatment.

Interventions

DRUGBotulinic toxin (Botox)

Patients may benefit, depending on the draw, in addition to their orthosis, intramuscular injections of botulinum toxin.These injections are among 6 in the muscles posterior (rear) of the leg paralyzed with tracking electromyographic to ensure the accuracy of the injection.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Stroke patient with equinovarus foot due to severe lower limb extensor spasticity with impaired foot contact during walking * Ability to walk for at least 10 meters with or without aid * Stroke interval \< 12 months * Age \> 18 years old * Weight \> 30 kg and \< 100 kg * Written informed consent

Exclusion criteria

* Stroke interval \> 12 months * Age \< 18 years old * Pregnancy * Neuromuscular disease * Previous treatment with BTA * Fixed contractures impairing mobility * Mini-Mental Status Examination \< 25 * Aminosides treatment.

Design outcomes

Primary

Measure	Time frame
Plantar contact during walking	—

Secondary

Measure	Time frame
Barthel index	—
MIF	—
Gait velocity	—
Asworth scale	—
Ankle range of motion	—
Autosatisfaction by EVA	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026