Adult Subjects Suffering From Lower Limb Spasticity Following Stroke (VALGAS)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Ipsen

ClinicalTrials.gov Identifier:

NCT01444794

First received: September 27, 2011

Last updated: January 31, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

September 27, 2011

Last Updated Date

January 31, 2013

Start Date ^ICMJE

September 2011

Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale (GAS). [ Time Frame: Between 1 and 3 months from inclusion ] [ Designated as safety issue: No ]

Assessed using the Goal Attainment Scale (GAS).

Original Primary Outcome Measures ^ICMJE

Responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale (GAS). [ Time Frame: Between 1 and 3 months from inclusion ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01444794 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Overall attainment of treatment goals [ Time Frame: Between 1 and 3 months from inclusion ] [ Designated as safety issue: No ]
Assessed using the GAS T-Score.
The use of standardized outcome measures and their results (e.g. muscle tone reduction, pain scores, functional tests). [ Time Frame: Up to 5 months ] [ Designated as safety issue: No ]
Description of injection practices (BoNT-A: doses, volume, injection points, electromyography, electrostimulation and ecography). [ Time Frame: Up to 5 months ] [ Designated as safety issue: No ]
Global assessment of benefits by both the investigator and the subject (or guardian). [ Time Frame: Up to 5 months ] [ Designated as safety issue: No ]
Assessed using a 5-point scale - much worse/worse/unchanged/better/much better

Original Secondary Outcome Measures ^ICMJE

Assessment of the overall attainment of treatment goals using GAS T-Score. [ Time Frame: Between 1 and 3 months from inclusion ] [ Designated as safety issue: No ]
Document the use of standardized outcome measures and their results (e.g. muscle tone reduction, pain scores, functional tests). [ Time Frame: Up to 5 months ] [ Designated as safety issue: No ]
Description of injection practices (BoNT-A: doses, volume, injection points, electromyography, electrostimulation and ecography). [ Time Frame: Up to 5 months ] [ Designated as safety issue: No ]
Global assessment of benefits by both the investigator and the subject (or guardian). [ Time Frame: Up to 5 months ] [ Designated as safety issue: No ]
Assessed using a 5-point scale - much worse/worse/unchanged/better/much better

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Adult Subjects Suffering From Lower Limb Spasticity Following Stroke

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic

Condition ^ICMJE

Spasticity

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

100

Estimated Completion Date

May 2013

Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Spain

Administrative Information

NCT Number ^ICMJE

NCT01444794

Other Study ID Numbers ^ICMJE

A-92-52120-159

Has Data Monitoring Committee

Not Provided

Responsible Party

Ipsen

Study Sponsor ^ICMJE

Ipsen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Elena Hernandez

Ipsen

Information Provided By

Ipsen

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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