AbstractObjectives To determine whether the Motor Training provided to people with spinal cord injury (SCI) in the Early and Intensive Motor Training for people with Spinal Cord Injuries (SCI-MT) Trial was delivered by therapists and received by participants according to the protocol. Intervention delivery and intervention receipt correspond to two fidelity domains of the National Institutes of Health Behaviour Change Consortium (NIH BCC) framework. Design Observational and audit study. Setting Inpatient rehabilitation gymnasiums. Participants Therapists administering, and participants receiving the Motor Training within the SCI-MT Trial. Interventions Not applicable Main Outcome Measures Indirect measures included audits of Practice Sheets (exercise training logs) and Trial Charts. Direct measures comprised 40 spot audits of treatment sessions using a checklist assessing adherence to the key principles of Motor Training. Results The protocol required therapists to provide 12 hours of intensive Motor Training per week for 10 weeks (120 hours total), and participants were expected to spend as much time as possible actively exercising during sessions. The Trial Chart audit showed the participants attended a median of 11.0 (IQR 9.8 to 11.9) hours per week, for a median of 10.0 (IQR 9.4 to 10.4) weeks, equivalent to a median of 105.8 (IQR 89.8 to 113.2) hours. The median adherence of therapists' delivery of Motor Training to the key principles assessed in spot audits was 100% (IQR 87 to100%). Participants actively exercised for a median of 73.7 (IQR 63.0 to 91.3) hours over the 10-week trial period. Conclusion The Motor Training provided as part of the SCI-MT Trial was largely delivered by therapists and received by participants as intended. These findings strengthen confidence in the fidelity of the intervention and will support interpretation of the trial's outcomes.
Ben et al. (Sun,) studied this question.