Adult Subjects Suffering From Lower Limb Spasticity Following Stroke

Spasticity Clinical Trial

— VALGAS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01444794
• Other study ID #: A-92-52120-159
• Status: Completed
• Start date: September 2011
• Est. completion date: February 2013

Study information

• Verified date: November 2020
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Muscle Spasticity
• Spasticity

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

Spain, 

Outcome

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