Quality of Life Assessment Using the Leg Activity Measure in Ambulatory Individuals with Leg Spasticity: Findings from a Longitudinal, Observational Study Evaluating the Effectiveness of AbobotulinumtoxinA in Routine Practice

Objective:To evaluate the effect of repeat abobotulinumtoxinA treatment on quality of life (QOL) in patients with leg spasticity. Design:Secondary analysis of the prospective, longitudinal (16mo), observational AboLiSh study. Setting:Specialist neurorehabilitation centers across 9 countries. Participants:Ambulatory adults (66.4% men, mean age 53.9y) with unilateral lower limb spasticity able to take ≥5 steps with or without assistance. Interventions:Patients were treated with abobotulinumtoxinA (up to 6 cycles) per local guidelines to achieve individualized treatment goals. Main Outcome Measures:QOL was assessed at the start of each cycle using the symptom-specific Leg Activity measure (LegA; Parts A: passive function, B: active function, C: QOL impact) and the generic EQ-5D-5L scale. Results:At the population level, QOL improved on both scales across the first 4 treatment cycles. LegA Part C scores decreased and EQ-5D-5L index values increased with repeat treatment. LegA Part C scores showed moderate-to-strong inverse correlations with EQ-5D-5L index values at each cycle (Pearson's R: Cycle 1: -0.66; Cycle 2: -0.57; Cycle 3: -0.60; Cycle 4: -0.59; all P<.0001). LegA Part A scores were moderately-to-strongly correlated with EQ-5D-5L self-care domain scores across cycles 1-3 (Pearson's R: Cycle 1: 0.60; Cycle 2: 0.58; Cycle 3: 0.50; Cycle 4: 0.34; all P<.0001). LegA Part B scores were moderately-to-strongly correlated with EQ-5D-5L mobility domain scores across all cycles (Pearson's R: Cycle 1, 0.58; Cycle 2, 0.57; Cycle 3, 0.57; Cycle 4, 0.59; all P<.0001). Conclusions:Repeat lower limb treatment with abobotulinumtoxinA improved QOL as assessed by both symptom-specific and generic instruments. The significant correlations between LegA Part C and EQ-5D-5L support validity of the LegA to assess the impact of treatment on QOL in patients with leg spasticity.