The Impact of an Evidence-Informed Spinal Cord Injury Activities of Daily Living Education Manual (SADL-eM): Protocol for a Randomized Controlled Trial

Abstract

Background Spinal cord injury (SCI) is a catastrophic injury associated with functional loss and life-threatening complications. Many people with SCI in the Gaza Strip of Palestine are discharged from inpatient rehabilitation to the community while still lacking many daily life skills. This randomized controlled trial (RCT) seeks to test the impact of the Spinal Cord Injury Activities of Daily Living Education Manual (SADL-eM)—an evidence-based occupational therapy patient educational intervention—on rehabilitation outcomes. Objective The proposed trial aims to evaluate the SADL-eM intervention compared with standard treatment among people with SCI. Methods This is a parallel RCT with two study arms: intervention and control. A total of 90 patients treated in inpatient rehabilitation settings will be randomly allocated to two study groups. Both groups will receive standard care. The intervention group will also use the SADL-eM with their treating occupational therapist during rehabilitation. The SADL-eM is a comprehensive activities of daily living (ADL) educational tool that was codeveloped with people with SCI and stakeholders across Gaza. The self-report version of the Spinal Cord Independence Measure will be used on admission (ie, baseline measure) and after 6 weeks as the primary outcome measure. Secondary outcomes include the third version of the Spinal Cord Independence Measure, the Private Religiousness Practices Scale, the Organizational Religiousness Short-Form, additional ADL domains covered by the education manual, and adherence to the intervention. The effect of the intervention will be determined using repeated-measures analysis of variance. Results This study will be conducted from April 2021 through December 2022, with results expected to be available in January 2023. Conclusions If the SADL-eM is demonstrated as clinically effective, this will have significant implications for occupational therapy interventions in low- and middle-income countries. Trial Registration ClinicalTrials.gov NCT04735887; https://clinicaltrials.gov/ct2/show/NCT04735887