Was the Motor Training in the SCI-MT Trial Delivered by Therapists and Received by Participants According to the Protocol? A Fidelity Analysis.

OBJECTIVES

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 2 fidelity domains of the National Institutes of Health Behavior Change Consortium framework.

DESIGN

Observational and audit study.

SETTING

Inpatient rehabilitation gymnasiums.

PARTICIPANTS

Therapists administering and participants (n=107) 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 (120h 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 hours (interquartile range [IQR], 9.8-11.9) per week, for a median of 10.0 weeks (IQR, 9.4-10.4), equivalent to a median of 105.8 hours (IQR, 89.8-113.2). The median adherence of therapists' delivery of motor training to the key principles assessed in spot audits was 100% (IQR, 87%-100%). Participants actively exercised for a median of 73.7 hours (IQR, 63.0-91.3) over the 10-week trial period.

CONCLUSIONS

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.