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VALGAS: Adult Subjects Suffering From Lower Limb Spasticity Following Stroke

Sponsor
Ipsen (Industry)
Overall Status
Completed
CT.gov ID
NCT01444794
Collaborator
(none)
100
Enrollment
24
Locations
17.1
Duration (Months)
4.2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    100 participants
    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
    Study Start Date :
    Sep 1, 2011
    Actual Primary Completion Date :
    Sep 1, 2012
    Actual Study Completion Date :
    Feb 1, 2013

    Outcome Measures

    Primary Outcome Measures

    1. Responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale (GAS). [Between 1 and 3 months from inclusion]

      Assessed using the Goal Attainment Scale (GAS).

    Secondary Outcome Measures

    1. Overall attainment of treatment goals [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). [Up to 5 months]

    3. Description of injection practices (BoNT-A: doses, volume, injection points, electromyography, electrostimulation and ecography). [Up to 5 months]

    4. Global assessment of benefits by both the investigator and the subject (or guardian). [Up to 5 months]

      Assessed using a 5-point scale - much worse/worse/unchanged/better/much better

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Hospital de Cruces Barakaldo Spain
    2 Hospital Clinic i Provincial de Barcelona Barcelona Spain
    3 Hospital de Bellvitge Barcelona Spain
    4 Hospital Mutua de Terrassa Barcelona Spain
    5 Hospital Sant Pau Barcelona Spain
    6 Hospital Vall Hebron Barcelona Spain
    7 Hospital Puerta del Mar Cadiz Spain
    8 Hospital de Magdalena Castellón De La Plana Spain
    9 Hospital Maritimo de Oza Coruña Spain
    10 Hospital de Gorliz Gorraiz Spain
    11 Hospital Dr. Negrín Las Palmas De Gran Canaria Spain
    12 Hospital Insular Las Palmas De Gran Canaria Spain
    13 Hospital De la Fundación Jimenez Madrid Spain
    14 Hospital la Paz Madrid Spain
    15 Hospital La Princesa Madrid Spain
    16 Hospital Carlos Haya Malaga Spain
    17 Hospital Virgen de la Victoria Malaga Spain
    18 Hospital Morales Meseguer Murcia Spain
    19 Hospital de Valdecilla Santander Spain
    20 Hospital Ntra. Sra. De La Candelaria Tenerife Spain
    21 Hospital La Fe Valencia Spain
    22 Hospital Valencia al Mar Valencia Spain
    23 Hospital Povisa Vigo Spain
    24 Hospital Xeral de Vigo Vigo Spain

    Sponsors and Collaborators

    • Ipsen

    Investigators

    • Study Director: Ipsen Medical Director, Ipsen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ipsen
    ClinicalTrials.gov Identifier:
    NCT01444794
    Other Study ID Numbers:
    • A-92-52120-159
    First Posted:
    Oct 3, 2011
    Last Update Posted:
    Nov 5, 2020
    Last Verified:
    Nov 1, 2020
    Keywords provided by Ipsen
    Lower limb spasticity
    Additional relevant MeSH terms:
    Muscle Spasticity

    Study Results

    No Results Posted as of Nov 5, 2020