Adult Subjects Suffering From Lower Limb Spasticity Following Stroke (VALGAS)

Ipsen

Status: Completed

Conditions: Spasticity

Study type: Observational

Funder types: Industry

Identifiers

NCT01444794

A-92-52120-159

Details and patient eligibility

About

The purpose of the protocol is to assess the responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale following one botulinum toxin type-A (BoNT-A) injection cycle in accordance with routine practices.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Suffering from lower limb spasticity following stroke
• With at least a 12-week interval between the last BoNT-A injection and inclusion
• Decision already been agreed to inject BoNT-A

Exclusion criteria

• Documented positive antigenicity to botulinum toxin
• Any neuromuscular junction indication
• Severe muscle atrophy in any muscle to be injected
• Any other indication that might interfere with rehabilitation or the evaluation of results