RELIEF Study: Lower Limb Pain Relief After Injection Cycles in Adults Suffering From Lower Limb Spasticity Following Stroke
NCT ID: NCT02020980
Last Updated: 2019-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
186 participants
OBSERVATIONAL
2014-04-30
2018-03-05
Brief Summary
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Treatment goals can vary greatly from one patient to another and there is no unique, single outcome that reflects the treatment benefits in all the cases. Therefore, this study with special focus on the achievement of therapeutic goals, will allow the identification of each patient's specific goals regarding the improvement of the functional outcomes, the quality of life and patient well-being.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Post-stroke lower limb spasticity patients
Botulinum toxin type A
This is an observational study designed to reflect the clinical practice in real life as closely as possible.
Botulinum Toxin Type A (BoNT-A) injection administered according to the local Summary of Product Characteristics (SmPC) and the locally agreed treatment guidelines.
Interventions
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Botulinum toxin type A
This is an observational study designed to reflect the clinical practice in real life as closely as possible.
Botulinum Toxin Type A (BoNT-A) injection administered according to the local Summary of Product Characteristics (SmPC) and the locally agreed treatment guidelines.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Post-stroke lower-limb spasticity
* Prior agreement with the patient to inject BoNT-A
* If previously treated with BoNT-A, (at least 3 months interval between last injection and inclusion).
* Therapeutic goals agreed jointly with the patient
* Functional Ambulation Classification (FAC) score 2-5
* Capacity to comply with the protocol
* Written informed consent
Exclusion Criteria
* Neuromuscular disease
* Use of medications that interfere with neuromuscular transmission
* Severe muscle atrophy in any muscle to be injected
* Any other indication that might interfere with rehabilitation or the evaluation of results
* Any non-stroke spasticity diagnosis
* Pregnancy or nursing mothers
* Previous participation in any study using Goal Attainment Scale (GAS)
18 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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Hospital Marítimo Oza
A Coruña, , Spain
Hospital General de Albacete
Albacete, , Spain
Hospital de Basurto
Bilbao, , Spain
Hospital de Cruces
Bilbao, , Spain
Hospital de Galdácano
Bilbao, , Spain
Hospital Gorliz
Bilbao, , Spain
Hospital Guadalajara
Guadalajara, , Spain
Hospital Dr Negrín
Las Palmas de Gran Canaria, , Spain
Hospital Insular
Las Palmas de Gran Canaria, , Spain
Hospital San Pedro
Logroño, , Spain
Fundación Jimenez Díaz
Madrid, , Spain
Hospital 12 Octubre
Madrid, , Spain
Hospital Alcorcón
Madrid, , Spain
Hospital General de Móstoles
Madrid, , Spain
Hospital Principe de Asturias de Alcalá de Henares
Madrid, , Spain
Hospital Universitario de la Princesa
Madrid, , Spain
Hospital Ourense
Ourense, , Spain
Hospital Son Espases
Palma de Mallorca, , Spain
Clinica Ubarmin
Pamplona, , Spain
Hospital Virgen de la Vega
Salamanca, , Spain
Hospital de Donosti
San Sebastián, , Spain
Hospital de la Candelaria
Santa Cruz de Tenerife, , Spain
Hospital Universitario Canarias
Santa Cruz de Tenerife, , Spain
Hospital Virgen de la Salud
Toledo, , Spain
Hospital Reina Sofía
Tudela, , Spain
Hospital Clinico Valladolid
Valladolid, , Spain
Hospital Xeral de Vigo
Vigo, , Spain
Hospital Universitario de Alaba
Vitoria-Gasteiz, , Spain
Countries
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Other Identifiers
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A-92-52120-181
Identifier Type: -
Identifier Source: org_study_id
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