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

September 27, 2011
June 19, 2013
September 2011
September 2012   (final data collection date for primary outcome measure)
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).
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 ]
Complete list of historical versions of study NCT01444794 on ClinicalTrials.gov Archive Site
  • 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
  • Assessment of the overall attainment of treatment goals using GAS T-Score. [ Time Frame: Between 1 and 3 months from inclusion ] [ Designated as safety issue: No ]
  • Document 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
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Adult Subjects Suffering From Lower Limb Spasticity Following Stroke
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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Primary care clinic

Spasticity
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
February 2013
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01444794
A-92-52120-159
Not Provided
Ipsen
Ipsen
Not Provided
Study Director: Elena Hernandez Ipsen
Ipsen
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP