Spasticity Clinical Trial
— VALGASOfficial 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
NCT number | NCT01444794 |
Other study ID # | A-92-52120-159 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 2011 |
Est. completion date | February 2013 |
Verified date | November 2020 |
Source | Ipsen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | February 2013 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital de Cruces | Barakaldo | |
Spain | Hospital Clinic i Provincial de Barcelona | Barcelona | |
Spain | Hospital de Bellvitge | Barcelona | |
Spain | Hospital Mutua de Terrassa | Barcelona | |
Spain | Hospital Sant Pau | Barcelona | |
Spain | Hospital Vall Hebron | Barcelona | |
Spain | Hospital Puerta del Mar | Cadiz | |
Spain | Hospital de Magdalena | Castellón De La Plana | |
Spain | Hospital Maritimo de Oza | Coruña | |
Spain | Hospital de Gorliz | Gorraiz | |
Spain | Hospital Dr. Negrín | Las Palmas De Gran Canaria | |
Spain | Hospital Insular | Las Palmas De Gran Canaria | |
Spain | Hospital De la Fundación Jimenez | Madrid | |
Spain | Hospital la Paz | Madrid | |
Spain | Hospital La Princesa | Madrid | |
Spain | Hospital Carlos Haya | Malaga | |
Spain | Hospital Virgen de la Victoria | Malaga | |
Spain | Hospital Morales Meseguer | Murcia | |
Spain | Hospital de Valdecilla | Santander | |
Spain | Hospital Ntra. Sra. De La Candelaria | Tenerife | |
Spain | Hospital La Fe | Valencia | |
Spain | Hospital Valencia al Mar | Valencia | |
Spain | Hospital Povisa | Vigo | |
Spain | Hospital Xeral de Vigo | Vigo |
Lead Sponsor | Collaborator |
---|---|
Ipsen |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale (GAS). | Assessed using the Goal Attainment Scale (GAS). | Between 1 and 3 months from inclusion | |
Secondary | Overall attainment of treatment goals | Assessed using the GAS T-Score. | Between 1 and 3 months from inclusion | |
Secondary | The use of standardized outcome measures and their results (e.g. muscle tone reduction, pain scores, functional tests). | Up to 5 months | ||
Secondary | Description of injection practices (BoNT-A: doses, volume, injection points, electromyography, electrostimulation and ecography). | Up to 5 months | ||
Secondary | Global assessment of benefits by both the investigator and the subject (or guardian). | Assessed using a 5-point scale - much worse/worse/unchanged/better/much better | Up to 5 months |
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