Participation Education Intervention for People With SCI From LMIC: A Pilot Randomized Clinical Trial.

Abstract

Introduction: Spinal cord injury (SCI) is associated with inequality-related participation restrictions. Participation education has been proposed as an intervention to promote participation in daily occupations. This pilot randomized clinical trial (RCT) evaluates the feasibility and minimal effect of the SADL-eM, a participation educational intervention, on the participation of people with spinal cord injury (PW-SCI) in daily occupations.

Methods: A two-arm pilot RCT included 32 PW-SCI from three inpatient rehabilitation settings in the Gaza Strip aged 18-65 years. Eligible cases were randomized equally into two groups. Both groups received standard care. The intervention group also used the SADL-eM during occupational therapy sessions. Participation and adherence were assessed at baseline and after 6 weeks. The Arabic version of the Spinal Cord Independence Measure-Self Reported (SCIM-SR-Ar) was the primary outcome measure.

Results: Demographic and injury characteristics were homogenous at baseline (p > 0.05). There was no difference between groups at baseline (p < 0.05). Comparing intervention to standard care, the SADL-eM was insignificant after 6 weeks of intervention (p > 0.05) while the inpatient rehabilitation improved participation in daily occupations (16.06%-17.00%) in the total sample (p ≤ 0.001).

Conclusion: There was an improvement in all outcome measures used; however, the SADL-eM did not reach significance. The intended RCT has major barriers, for example, a low recruitment rate. Community settings can be unique for such an RCT.

Trial registration: ClinicalTrials.gov identifier: NCT04735887.