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An International, Multicentre, Prospective, Single Arm Study to Assess the Effect on Voluntary Movements of AbobotulinumtoxinA 1500 U Administered in Both Upper and Lower Limbs in Conjunction with a G...

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Reference: EUCTR2016-001989-29

An International, Multicentre, Prospective, Single Arm Study to Assess the Effect on Voluntary Movements of AbobotulinumtoxinA 1500 U Administered in Both Upper and Lower Limbs in Conjunction with a Guided Self Rehabilitation Contract in Adult Subjects with Spastic Hemiparesis

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Extract

The primary objective is to assess the responder rate as defined by the improvement of composite active range of motion (AROM) in the primary targeted limb, either upper limb (UL) or lower limb (LL), depending on which one has been selected as a primary treatment target (TT), following two consecutive AbobotulinumtoxinA injections combined with a Guided Self rehabilitation Contract (GSC) in subjects with spastic hemiparesis following acquired brain injury (ABI).

Inclusion criteria

  • Spastic Hemiparesis

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