Clinical trial NCT01444794: Adult Subjects Suffering From Lower Limb Spasticity Following Stroke
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spasticity
Keywords: Lower limb spasticity
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2011-10-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

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.


Eligibility 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

Primary outcomes:
measure: Responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale (GAS).
timeFrame: Between 1 and 3 months from inclusion
Secondary outcomes:
measure: Overall attainment of treatment goals
timeFrame: Between 1 and 3 months from inclusion
measure: The use of standardized outcome measures and their results (e.g. muscle tone reduction, pain scores, functional tests).
timeFrame: Up to 5 months
measure: Description of injection practices (BoNT-A: doses, volume, injection points, electromyography, electrostimulation and ecography).
timeFrame: Up to 5 months
measure: Global assessment of benefits by both the investigator and the subject (or guardian).
timeFrame: Up to 5 months
Other outcomes:
Locations:
city: Barakaldo
country: Spain
facility: Hospital de Cruces
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
city: Barcelona
country: Spain
facility: Hospital de Bellvitge
city: Barcelona
country: Spain
facility: Hospital Mutua de Terrassa
city: Barcelona
country: Spain
facility: Hospital Sant Pau
city: Barcelona
country: Spain
facility: Hospital Vall Hebron
city: Cadiz
country: Spain
facility: Hospital Puerta del Mar
city: Castellón De La Plana
country: Spain
facility: Hospital de Magdalena
city: Coruña
country: Spain
facility: Hospital Maritimo de Oza
city: Gorraiz
country: Spain
facility: Hospital de Gorliz
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Dr. Negrín
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Insular
city: Madrid
country: Spain
facility: Hospital De la Fundación Jimenez
city: Madrid
country: Spain
facility: Hospital la Paz
city: Madrid
country: Spain
facility: Hospital La Princesa
city: Malaga
country: Spain
facility: Hospital Carlos Haya
city: Malaga
country: Spain
facility: Hospital Virgen de la Victoria
city: Murcia
country: Spain
facility: Hospital Morales Meseguer
city: Santander
country: Spain
facility: Hospital de Valdecilla
city: Tenerife
country: Spain
facility: Hospital Ntra. Sra. De La Candelaria
city: Valencia
country: Spain
facility: Hospital La Fe
city: Valencia
country: Spain
facility: Hospital Valencia al Mar
city: Vigo
country: Spain
facility: Hospital Povisa
city: Vigo
country: Spain
facility: Hospital Xeral de Vigo
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: