Effects of higher-frequency out-of-bed mobilization training on the recovery of acute stroke patients: study protocol for a randomized controlled trial

Abstract

Background Out-of-bed mobilization is a significant component within the rehabilitation of people early after stroke. A top priority in acute stroke rehabilitation research is determining the optimal dose of out-of-bed mobilization exercises, such as frequency and timing. However, there is little evidence of the appropriate frequency out-of-bed mobilization for acute stroke patients. Aims The aim of the study described in this protocol is to investigate the effect of higher-frequency out-of-bed mobilization on the functional recovery of acute stroke patients. Methods This is a prospective randomized three-arm trial with the assessor blinded to the study intervention. 45 patients met the inclusion criteria will be randomly allocated to three groups, which are separately usual care (1 mobilization session/d), Frequency 1 group (2 mobilization sessions/d) and Frequency 2 group (4 mobilization sessions/d). Outcomes: The primary outcome is the modified Rankin Scale and the secondary outcomes are Rivermead Mobility Index, Fugl-Meyer (Lower Limb), Barthel Index and adverse events incidence. Outcomes will be measured at three time points. Summary: The proposed study will be beneficial for determining the frequency of out-of-bed mobilization, filling the gaps in the acute rehabilitation research field and optimising the recovery of people early after stroke. Trial registration: The proposed study has been registered at Chinese Clinical Trial on 11/03/2022, registry ID: ChiCTR2200057404.