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

November 4, 2020 updated by: Ipsen

A National, Prospective Cohort to Document the Effectiveness of One BoNT-A Injection Cycle Based on Attainment of Individual Person-centred Goals in Adult Subjects Suffering From Lower Limb Spasticity Following Stroke

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barakaldo, Spain
        • Hospital de Cruces
      • Barcelona, Spain
        • Hospital De Bellvitge
      • Barcelona, Spain
        • Hospital Sant Pau
      • Barcelona, Spain
        • Hospital Clinic i Provincial de Barcelona
      • Barcelona, Spain
        • Hospital Vall Hebron
      • Barcelona, Spain
        • Hospital Mútua de Terrassa
      • Cadiz, Spain
        • Hospital Puerta del Mar
      • Castellón De La Plana, Spain
        • Hospital de Magdalena
      • Coruña, Spain
        • Hospital Maritimo de Oza
      • Gorraiz, Spain
        • Hospital de Gorliz
      • Las Palmas De Gran Canaria, Spain
        • Hospital Dr. Negrín
      • Las Palmas De Gran Canaria, Spain
        • Hospital Insular
      • Madrid, Spain
        • Hospital La Paz
      • Madrid, Spain
        • Hospital La Princesa
      • Madrid, Spain
        • Hospital De la Fundación Jimenez
      • Malaga, Spain
        • Hospital Carlos Haya
      • Malaga, Spain
        • Hospital Virgen de la Victoria
      • Murcia, Spain
        • Hospital Morales Meseguer
      • Santander, Spain
        • Hospital de Valdecilla
      • Tenerife, Spain
        • Hospital Ntra. Sra. de la Candelaria
      • Valencia, Spain
        • Hospital La Fe
      • Valencia, Spain
        • Hospital Valencia al Mar
      • Vigo, Spain
        • Hospital Xeral de Vigo
      • Vigo, Spain
        • Hospital Povisa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale (GAS).
Time Frame: Between 1 and 3 months from inclusion
Assessed using the Goal Attainment Scale (GAS).
Between 1 and 3 months from inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall attainment of treatment goals
Time Frame: Between 1 and 3 months from inclusion
Assessed using the GAS T-Score.
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).
Time Frame: Up to 5 months
Up to 5 months
Description of injection practices (BoNT-A: doses, volume, injection points, electromyography, electrostimulation and ecography).
Time Frame: Up to 5 months
Up to 5 months
Global assessment of benefits by both the investigator and the subject (or guardian).
Time Frame: Up to 5 months
Assessed using a 5-point scale - much worse/worse/unchanged/better/much better
Up to 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

September 27, 2011

First Submitted That Met QC Criteria

September 29, 2011

First Posted (Estimate)

October 3, 2011

Study Record Updates

Last Update Posted (Actual)

November 5, 2020

Last Update Submitted That Met QC Criteria

November 4, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-92-52120-159

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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