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Completed

NCT Number: NCT04050527

Study to Assess the Effectiveness of AboBoNT-A Injections for Adult Lower Limb Spasticity in a Real Life Cohort

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.

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Key information

Conditions

Adult Lower Limb Spasticity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Princess Alexandra Hospital, Ipswich, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Subject centred Goal Attainment Scaling Leg T score (GASleg T)

    Time frame: 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 outcomes

  1. Muscle tone

    Time frame: 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).

  2. Severity of different aspects of impairment

    Time frame: 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.

  3. Total dose injected per cycle

    Time frame: 16 months

  4. Report muscles injected

    Time frame: 16 months

  5. Report dose per muscle

    Time frame: 16 months

  6. Assess correlations of subject centered goals

    Time frame: 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.

  7. Evolution of Quality of Life

    Time frame: 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".

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

International, Multicentre, Observational, Prospective, Longitudinal Study to Assess the Effectiveness of AboBoNT-A Injections for Adult Lower Limb Spasticity in a Real Life Cohort (AboLiSh)

Acronym: AboLiSh

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 8, 2019
Registry last updated
Aug 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.