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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01444794
First received: September 27, 2011
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

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.


Condition
Spasticity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Further study details as provided by Ipsen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Assessed using the Goal Attainment Scale (GAS).


Secondary Outcome Measures:
  • Overall attainment of treatment goals [ Time Frame: Between 1 and 3 months from inclusion ] [ Designated as safety issue: No ]
    Assessed using the GAS T-Score.

  • The use of standardized outcome measures and their results (e.g. muscle tone reduction, pain scores, functional tests). [ Time Frame: Up to 5 months ] [ Designated as safety issue: No ]
  • Description of injection practices (BoNT-A: doses, volume, injection points, electromyography, electrostimulation and ecography). [ Time Frame: Up to 5 months ] [ Designated as safety issue: No ]
  • Global assessment of benefits by both the investigator and the subject (or guardian). [ Time Frame: Up to 5 months ] [ Designated as safety issue: No ]
    Assessed using a 5-point scale - much worse/worse/unchanged/better/much better


Enrollment: 100
Study Start Date: September 2011
Study Completion Date: February 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01444794

Locations
Spain
Hospital Vall Hebron
Barcelona, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain
Hospital de Bellvitge
Barcelona, Spain
Hospital Sant Pau
Barcelona, Spain
Hospital Mutua de Terrassa
Barcelona, Spain
Hospital Puerta del Mar
Cadiz, Spain
Hospital de Magdalena
Castellon, Spain
Hospital Maritimo de Oza
Coruña, Spain
Hospital Dr. Negrín
Gran Canaria, Spain
Hospital Insular
Gran Canaria, Spain
Hospital La Princesa
Madrid, Spain
Hospital la Paz
Madrid, Spain
Hospital De la Fundación Jimenez
Madrid, Spain
Hospital Carlos Haya
Malaga, 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 Xeral de Vigo
Vigo, Spain
Hospital Povisa
Vigo, Spain
Hospital de Cruces
Vizcaya, Spain
Hospital de Gorliz
Vizcaya, Spain
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Elena Hernandez Ipsen
  More Information

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01444794     History of Changes
Other Study ID Numbers: A-92-52120-159
Study First Received: September 27, 2011
Last Updated: June 19, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Ipsen:
Lower limb spasticity

Additional relevant MeSH terms:
Muscle Spasticity
Muscle Hypertonia
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014