Adult Subjects Suffering From Lower Limb Spasticity Following Stroke

NCT01444794 | Completed

• 1 other identifier: A-92-52120-159
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 24

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.

Conditions

Spasticity

Keywords

Lower limb spasticity

Outcome Measures

Primary Outcomes (1)

• Responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale (GAS).

  Assessed using the Goal Attainment Scale (GAS).

  Between 1 and 3 months from inclusion

Secondary Outcomes (4)

• Overall attainment of treatment goals

  Between 1 and 3 months from inclusion

• 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

• Global assessment of benefits by both the investigator and the subject (or guardian).

  Up to 5 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

You may qualify if:

• Suffering from lower limb spasticity following stroke
• Decision already been agreed to inject BoNT-A

You may not qualify if:

• 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

Sponsors & Collaborators

• Ipsen: lead

Study Sites (24)

Hospital Maritimo de Oza

A Coruña, Spain

Location

Hospital de Cruces

Barakaldo, Spain

Location

Hospital Clinic i Provincial de Barcelona

Barcelona, Spain

Location

Hospital de Bellvitge

Barcelona, Spain

Location

Hospital Mutua de Terrassa

Barcelona, Spain

Location

Hospital Sant Pau

Barcelona, Spain

Location

Hospital Vall Hebron

Barcelona, Spain

Location

Hospital Puerta del Mar

Cadiz, Spain

Location

Hospital de Magdalena

Castellon, Spain

Location

Hospital de Gorliz

Gorraiz, Spain

Location

Hospital Dr. Negrín

Las Palmas de Gran Canaria, Spain

Location

Hospital Insular

Las Palmas de Gran Canaria, Spain

Location

Hospital De la Fundación Jimenez

Madrid, Spain

Location

Hospital la Paz

Madrid, Spain

Location

Hospital La Princesa

Madrid, Spain

Location

Hospital Carlos Haya

Málaga, Spain

Location

Hospital Virgen de la Victoria

Málaga, Spain

Location

Hospital Morales Meseguer

Murcia, Spain

Location

Hospital Ntra. Sra. De La Candelaria

Santa Cruz de Tenerife, Spain

Location

Hospital de Valdecilla

Santander, Spain

Location

Hospital La Fe

Valencia, Spain

Location

Hospital Valencia al Mar

Valencia, Spain

Location

Hospital Povisa

Vigo, Spain

Location

Hospital Xeral de Vigo

Vigo, Spain

Location

MeSH Terms

Conditions

Muscle Spasticity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2011
• First Posted: October 3, 2011
• Study Start: September 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: February 1, 2013
• Last Updated: November 5, 2020

Record last verified: 2020-11

Locations

ES (24)