Adult Subjects Suffering From Lower Limb Spasticity Following Stroke

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01444794

Acronym

VALGAS

Enrollment

100

Registered

2011-10-03

Start date

2011-09-30

Completion date

2013-02-28

Last updated

2020-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spasticity

Keywords

Lower limb spasticity

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Overall attainment of treatment goals	Between 1 and 3 months from inclusion	Assessed using the GAS T-Score.
The use of standardized outcome measures and their results (e.g. muscle tone reduction, pain scores, functional tests).	Up to 5 months	—
Description of injection practices (BoNT-A: doses, volume, injection points, electromyography, electrostimulation and ecography).	Up to 5 months	—
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

Countries

Spain

Outcome results