Adult Subjects Suffering From Lower Limb Spasticity Following Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-02-28

Brief Summary

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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

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Conditions

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Spasticity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Vigo, , Spain

Site Status

Countries

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Spain

Other Identifiers

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A-92-52120-159

Identifier Type: -

Identifier Source: org_study_id

Adult Subjects Suffering From Lower Limb Spasticity Following Stroke

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Ipsen

Responsible Party

Principal Investigators

Ipsen Medical Director

Locations

Hospital Maritimo de Oza

Hospital de Cruces

Hospital Clinic i Provincial de Barcelona

Hospital de Bellvitge

Hospital Mutua de Terrassa

Hospital Sant Pau

Hospital Vall Hebron

Hospital Puerta del Mar

Hospital de Magdalena

Hospital de Gorliz

Hospital Dr. Negrín

Hospital Insular

Hospital De la Fundación Jimenez

Hospital la Paz

Hospital La Princesa

Hospital Carlos Haya

Hospital Virgen de la Victoria

Hospital Morales Meseguer

Hospital Ntra. Sra. De La Candelaria

Hospital de Valdecilla

Hospital La Fe

Hospital Valencia al Mar

Hospital Povisa

Hospital Xeral de Vigo

Countries

Other Identifiers

A-92-52120-159