Study to Assess the Effectiveness of AboBoNT-A Injections for Adult Lower Limb Spasticity in a Real Life Cohort
- Conditions
- Adult Lower Limb Spasticity
- Registration Number
- NCT04050527
- Lead Sponsor
- Ipsen
- Brief Summary
The purpose of the protocol is to assess the longitudinal attainment of person-centered and function related goals of patients who receive AbobotulinumtoxinA (aboBoNT-A) injections for adult lower limb spasticity over a period of 16 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 438
- Adult male and female subjects ≥18 years of age
- Primary diagnosis with unilateral adult lower limb nonprogressive spasticity.
- Subject able to take more than five steps with or without assistance.
- Decision to treat the lower limb with aboBoNT-A by the care provider made prior to, and independently from, the decision to enroll the subject in the observational study as per country label.
- Previously untreated with BoNT-A (i.e. naïve to BoNT-A), or previously treated with a BoNT-A (i.e. non-naïve to BoNT-A). For those who were previously treated with BoNTA, they should have responded to BoNT-A treatment and at least 12 weeks should have elapsed from prior injection.
- Signed informed consent prior to participation in the study.
- Prior history of nonresponsiveness to BoNT-A therapy
- Previous treatment with BoNT-A of less than 12 weeks prior to enrolment in study.
- Current participation in any other clinical study or have participated within the 12 weeks prior to the Inclusion visit (Visit 1) of this study.
- Severe limitations in passive range of motion/contractures in the affected limb (MAS=4 in at least one of the joints in the lower limb).
- Limb surgery or intrathecal baclofen therapy placement for spasticity within 3 months.
- Nonambulatory subject.
- Pregnant and lactating women.
- Progressive neurological conditions or diagnosis of cerebral palsy.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Subject centred Goal Attainment Scaling Leg T score (GASleg T) 16 months Mean individual GASleg T score. Goal attainment for each goal will be recorded clinically on a 5-point verbal rating scale (range -2 to +2) and goal scores combined to give an aggregated T score using a standard formula (GASleg T score). Range meaning is -2 = much less than expected and +2 = much more than expected.
The subject and/or caregiver to identify the main goal areas and establish agreed person centred and function related goals guided by GASleg (usually one primary and up to two secondary goals) at each visit. Goal attainment will be evaluated at the routine follow up visit.
Goals will be redefined and/or newly set at each injection visit or as per routine practice if further injections are not given. Goals will be SMART \[Specific, measurable, attainable, relevant, and time-based\]
- Secondary Outcome Measures
Name Time Method Muscle tone 16 months Muscle tone will be evaluated using the Modified Ashworth Scale (MAS) /Tardieu Scale according to clinical practice. The MAS is a six point scale (with available scores of 0, 1, 1+, 2, 3 and 4) reporting changes in muscle tone during muscle flexion or extension. Tardieu scale quantifies muscle spasticity by assessing the response of the muscle to stretch applied at specified velocities. It can therefore broadly differentiate between the two key factors explaining resistance to passive stretch, namely contracture (non-neural factors) and spasticity (neural factors).
Assess correlations of subject centered goals 16 months Correlations of subject centred goals and related standardised rating scales will be assessed using GASleg and standardised outcome measures selected according to the goals for treatment.
Total dose injected per cycle 16 months Report dose per muscle 16 months Severity of different aspects of impairment 16 months Severity of different aspects of impairment in subjects with neurological injury will be evaluated using the Lower Limb Spasticity adapted Neurological Impairment Scale. (LLS-NIS) Higher LLS-NIS scores indicate more severe impairment (LLS-NIS). Higher LLS-NIS scores indicate more severe impairment.
Report muscles injected 16 months Evolution of Quality of Life 16 months Assess the evolution of QoL at each visit based on the EQ-5D-5L and the QoL element of LegA. This is a descriptive scale that covers 5 dimensions: mobility, self-care, usual activities,pain/discomfort and anxiety/depression. the scale consist of 5 levels, where level one corresponds to "no problems" and level 5 corresponds to "extreme problem".
Trial Locations
- Locations (51)
Wake Forest University Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Riverhills Healthcare
🇺🇸Cincinnati, Ohio, United States
OrthoNeuro
🇺🇸Columbus, Ohio, United States
Good Shepherd Rehabilitation Hospital - Neurology
🇺🇸Allentown, Pennsylvania, United States
University of Texas Southwestern
🇺🇸Dallas, Texas, United States
Beaumont Hospital, Grosse Pointe - Neurology
🇺🇸Grosse Pointe, Michigan, United States
Hospital de Base de São José do Rio Preto at Centro Integrado de Pesquisa (CIP) - Neurology
🇧🇷São José Do Rio Preto, Brazil
McGill University Health Center
🇨🇦Montréal, Canada
Glenrose Rehabilitation Hospital
🇨🇦Edmonton, Canada
Centre Hospitalier Regional Universitaire (CHRU) de Lille - Hopital Pierre Swynghedauw - Neurology
🇫🇷Lille, France
Neurologische Klinik und Poliklinik
🇩🇪Würzburg, Germany
SP ZOZ Szpital Uniwersytecki w Krakowie
🇵🇱Kraków, Poland
Wojewódzki Szpital Specjalistyczny we Wrocławiu
🇵🇱Wroclaw, Poland
Federal State Budgetary Institution "All-Russian Center for Emergency Medicine and Medical Radiology named after A.M. Nikiforov" of the EMERCOM of Russia
🇷🇺Saint-Petersburg, Russian Federation
MedStar National Rehabilitation Hospital
🇺🇸Washington, District of Columbia, United States
Neurology Center of NE,PC - Neurology
🇺🇸Foxboro, Massachusetts, United States
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto (HCFMRP) - Neurology
🇧🇷Ribeirão Preto, Brazil
Università Degli studi della Campania - Luigi Vanvitelli - Neurologica
🇮🇹Napoli, Italy
PO Villa Sofia, AO Ospedali Riuniti Villa Sofia-Cervello
🇮🇹Palermo, Italy
SAHI Interregional Clinical Diagnostic Center
🇷🇺Kazan, Russian Federation
CHU - Hôpital Pellegrin - Neurologie
🇫🇷Bordeau, France
Mazowiecki Szpital Brodnowski w Warszawie Sp. z o.o. Brodnowskie Centrum Kliniczne Poliklinika Brodnowskiego Centrum Klinicznego
🇵🇱Warsaw, Poland
Pavlov First Saint-Petersburg State Medical University - Neurology
🇷🇺Saint-Petersburg, Russian Federation
The University of Utah School of Medicine
🇺🇸Salt Lake City, Utah, United States
CHU RAYMOND POINCARE - Neurology
🇫🇷Garches, France
Pole Saint Helier
🇫🇷Rennes, France
Universitätsklinikum Erlangen
🇩🇪Erlangen, Germany
Istituto Scientifico di Riabilitazione di Veruno, Fondazione
🇮🇹Novara, Italy
Instytut Psychiatrii i Neurologii
🇵🇱Warsaw, Poland
Regional state budget health institution "City Hospital № 5"
🇷🇺Barnaul, Russian Federation
Höpital Sainte-Marie - Neurology
🇫🇷Paris, France
Neurologie und Psychosomatik am Wittenbergplatz
🇩🇪Berlin, Germany
AO S.Camillo-Forlanini
🇮🇹Roma, Italy
Centre Hospitalier Universitaire De Reims - Hopital Maison B
🇫🇷Reims, France
Medizinische Hochschule Hannover - Neurology Neurologische Poliklinik
🇩🇪Hannover, Germany
Universitätsklinikum/Neurologie
🇩🇪Luebeck, Germany
Universita degli Studi di Verona - Centro di Ricerca in Riabilitazione Neuromotoria e Cognitiva (CRRNC) - Neurology
🇮🇹Verona, Italy
FGBOU VO "Ural state medical university"
🇷🇺Ekaterinburg, Russian Federation
Bekhterev National Research Medical Center for Psychiatry
🇷🇺Saint Petersburg, Russian Federation
National Medical Research Treatment and Rehabilitation Center of the Ministry of Health of Russia
🇷🇺Moscow, Russian Federation
Rancho Los Amigos National Rehabilitation Center (RLANRC) - Neurology
🇺🇸Downey, California, United States
Kansas City Bone and Joint Clinic, P.A. (KCBJ) - Overland Pa
🇺🇸Leawood, Kansas, United States
Dayton Center for Neurological Disorders
🇺🇸Centerville, Ohio, United States
Yeshiva University - Albert Einstein College of Medicine - Montefiore Medical Center (MMC) - Neurology
🇺🇸Bronx, New York, United States
MossRehab - Einstein Medical Center
🇺🇸Elkins Park, Pennsylvania, United States
Rehabilitation Associates - Neurology
🇺🇸Paoli, Pennsylvania, United States
Medical College of Wisconsin - Froedtert Hospital
🇺🇸Milwaukee, Wisconsin, United States
Princess Alexandra Hospital
🇦🇺Ipswich, Australia
Royal Prince Alfred Hospital
🇦🇺Rozelle, Australia
River Valley Health - Stan Cassidy Foundation - Stan Cassidy
🇨🇦Fredericton, Canada
Wojew. Wielospecjalistyczne Centrum Onkologii i Traumatologii im.M.Kopernika w Lodzi
🇵🇱Łódź, Poland