Rehabilitation nursing for motor functional recovery of acute ischaemic stroke: study protocol for a randomised controlled trial

Abstract

Introduction: Stroke is the second-leading cause of death and disability in the world, and patients with stroke often suffer from functional impairments and need rehabilitation. Notably, there is much evidence that rehabilitation can lead to better mortality and morbidity outcomes. The evidence for the effectiveness of rehabilitation nursing, however, is limited. Thus, this study seeks to explore whether rehabilitation nursing is not inferior to usual rehabilitation for motor functional recovery in patients with acute ischaemic stroke.

Methods and analysis: We will conduct an assessor-blinded parallel randomised controlled trial of patients who meet the inclusion criteria after stratification by weighted corticospinal tract lesion load. The experimental group will receive rehabilitation nursing by trained and qualified nurses (seven consecutive days, two sessions per day, 30 min each session). The control group will receive usual rehabilitation provided by therapists (seven consecutive days, two sessions per day, 30 min each session). The primary outcome measures are the Motor Assessment Scale, the Fugl-Meyer Assessment and the Action Research Arm Test. The secondary outcome measures are the modified Rankin Scale, the modified Barthel Index and the National Institute of Health Stroke Scale. Primary and secondary outcome assessment will be performed before and after the intervention, and secondary outcome be assessed at 4 and 12 weeks follow-up. We will recruit 224 patients within a period of 12-18 months from a hospital in southeastern China.

Ethics and dissemination: The study was approved by the Human Research Ethics Committee from the corresponding author's hospital (approval Number is Ethical Review Study No. 2018 - 112). Peer-reviewed journals and presentations at national and international conferences will be used to disseminate the results.

Trial registration number: NCT03702452.

Keywords: motor function; nursing; rehabilitation; stroke.

Figure 1

Flow diagram of study protocol. wCST-LL, weighted corticospinal tract lesion load; primary outcomes measures: MAS, Motor Assessment Scale; FMA, fugl-meyer assessment; ARAT, action research arm test; secondary outcomes measures: MBI, modified Barthel Index; mRS, modified Rankin Scale; NIHSS: National Institute of Health Stroke Scale;

Figure 2

Schedule of enrolment, intervention and assessments. -t0: admitted but not grouped; t0: baseline, day of enrolment; ta: 3 days post-intervention, reevaluated Modified Barthel Index to adjust protocol; t1: 7 days post-intervention; td: on the day of discharge; t2: 4 weeks post-intervention; t3: 12 weeks post-intervention.