To measure the intervention fidelity of the SCI-MT trial. The purpose of this study is to determine whether the intervention has been delivered as intended by the trial protocol.
Indirect and direct measures have been used to measure intervention fidelity. The indirect measures include audits of practice sheets (i.e. exercise training logs) and trial charts. The direct measures include spot audits, involving observations of SCI-MT intervention sessions. The audits have been completed using checklists, which reflect key aspects of the SCI-MT intervention based on the trial protocol.
The protocol dictated that intervention participants receive 120 hours of intensive Motor Training over a 10-week period. According to the audits of 43 randomly selected trial charts and practice sheets, the participants attended a median (IQR) of 106.0 (97.9 to 115.0) hours of additional training over a median of 10 (9.4 to 10.4) weeks. In that time, they spent a median of 74.7 (63.5 to 92.0) hours actively exercising. Audits of practice sheets found strong evidence that therapists set weekly goals, used exercises that involved contractions below the level of injury, and progressed the difficulty of exercises during 10-week trial period. Spot audits suggested that the SCI-MT intervention was delivered with high levels of fidelity, adhering to most key components of Motor Training. The median (IQR) fidelity of all observed sessions was 87% (78% to 91%).
It was feasible to deliver intensive Motor Training to participants as part of the SCI-MT Trial. The intervention was largely delivered as intended.
Monitoring and evaluating the fidelity of complex interventions of trials prior to knowing the results provides an unbiased measure of how closely the protocol was followed. This helps the future interpretation of trial results and the possible future rollout of the intervention.
Spinal Cord Injury
Intervention fidelity
