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OpenTrials
Completed

NCT Number: NCT01444794

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Maritimo de Oza, A Coruña, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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).

Secondary outcomes

  1. Overall attainment of treatment goals

    Time frame: Between 1 and 3 months from inclusion

    Assessed using the GAS T-Score.

  2. The use of standardized outcome measures and their results (e.g. muscle tone reduction, pain scores, functional tests).

    Time frame: Up to 5 months

  3. Description of injection practices (BoNT-A: doses, volume, injection points, electromyography, electrostimulation and ecography).

    Time frame: Up to 5 months

  4. 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

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study 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

Acronym: VALGAS

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Oct 3, 2011
Registry last updated
Nov 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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