Adult Subjects Suffering From Lower Limb Spasticity Following Stroke

Completed

• Conditions: Spasticity

• Registration Number: NCT01444794
• Lead Sponsor: Ipsen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-27
• Study First Submitted QC: 2011-09-29
• Study First Posted: 2011-10-03
• Primary Completion: 2012-09
• Study Completion: 2013-02
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-04
• Last Update Posted: 2020-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale (GAS).	Between 1 and 3 months from inclusion	Assessed using the Goal Attainment Scale (GAS).

Secondary Outcome Measures

Name	Time	Method
Global assessment of benefits by both the investigator and the subject (or guardian).	Up to 5 months	Assessed using a 5-point scale - much worse/worse/unchanged/better/much better
Overall attainment of treatment goals	Between 1 and 3 months from inclusion	Assessed using the GAS T-Score.
The use of standardized outcome measures and their results (e.g. muscle tone reduction, pain scores, functional tests).	Up to 5 months
Description of injection practices (BoNT-A: doses, volume, injection points, electromyography, electrostimulation and ecography).	Up to 5 months

Trial Locations

Locations (24)

Hospital Xeral de Vigo; 🇪🇸 Vigo, Spain

Hospital de Gorliz; 🇪🇸 Gorraiz, Spain

Hospital Sant Pau; 🇪🇸 Barcelona, Spain

Hospital de Cruces; 🇪🇸 Barakaldo, Spain

Hospital Clinic i Provincial de Barcelona; 🇪🇸 Barcelona, Spain

Hospital de Bellvitge; 🇪🇸 Barcelona, Spain

Hospital Mutua de Terrassa; 🇪🇸 Barcelona, Spain

Hospital Vall Hebron; 🇪🇸 Barcelona, Spain

Hospital Puerta del Mar; 🇪🇸 Cadiz, Spain

Hospital de Magdalena; 🇪🇸 Castellón De La Plana, Spain

Hospital Maritimo de Oza; 🇪🇸 Coruña, Spain

Hospital Insular; 🇪🇸 Las Palmas De Gran Canaria, Spain

Hospital Dr. Negrín; 🇪🇸 Las Palmas De Gran Canaria, Spain

Hospital la Paz; 🇪🇸 Madrid, Spain

Hospital Carlos Haya; 🇪🇸 Malaga, Spain

Hospital La Princesa; 🇪🇸 Madrid, Spain

Hospital Virgen de la Victoria; 🇪🇸 Malaga, Spain

Hospital Morales Meseguer; 🇪🇸 Murcia, Spain

Hospital de Valdecilla; 🇪🇸 Santander, Spain

Hospital Ntra. Sra. De La Candelaria; 🇪🇸 Tenerife, Spain

Hospital La Fe; 🇪🇸 Valencia, Spain

Hospital Valencia al Mar; 🇪🇸 Valencia, Spain

Hospital Povisa; 🇪🇸 Vigo, Spain

Hospital De la Fundación Jimenez; 🇪🇸 Madrid, Spain