Effectiveness of upper limb robotic-assisted therapy in the early phase of stroke rehabilitation: A single-blind, randomised, controlled trial

Abstract

Upper limb (UL) robotic assisted therapy (RAT) is a powerful promising tool for stroke rehabilitation, particularly in the early stage. Associated to conventional therapy (CT), studies agreed that RAT decrease UL impairment. When it is provided as substitution, RAT is at least as effective as CT, but it remains uncertain if it is more effective than CT. In addition, studies often confine themselves to a single domains of the International Classification of Functioning framework (ICF). This study aims to perform a single-blind randomized controlled trial to evaluate effectiveness of UL RAT in the acute phase of stroke rehabilitation following ICF, with RAT as partial substitution to CT. Forty-five acute stroke patients were randomized into two groups (CT group, n = 22 and RAT group, n = 23). Both interventions were dose-matched about the duration of treatment and lasted nine weeks. The CT followed a standard rehabilitation. In the RAT group, four sessions of CT (25%) were substituted by RAT each week. RAT consisted of moving the paretic UL along a reference trajectory while the robot provided an assistance-as-needed. A blinded assessor evaluated the patients before and after the intervention and at 6-month post-stroke according to all domains of ICF. Seventeen patients dropped out during the study. The UL motor control (Fugl Meyer +16%; P = 0.05) and gross manual dexterity (Box and Block test +10 blocks/min; P = 0.02) improved significantly more in the RAT group than in the CT group at 6-months post-stroke. The ability to perform activities of daily living and their social participation tend also to improve more in the RAT group than in CT group. RAT is effective for the UL motor rehabilitation in the acute phase of stroke rehabilitation. Thus, a RAT protocol can be included in practice increasing patient intensity of rehabilitation and decreasing patient's impairments.