Table 2.
Events | Screening visit | Baseline visit | Randomisation | Treatment period | Early termination assessment | |
Interim assessment (after 20th treatment session) | End-of-treatment assessment (after 40th treatment session/14 weeks post first treatment visit) | End-of-study follow-up assessment (24 weeks post first treatment visit) | ||||
Consent | ||||||
Informed consent form | × | |||||
Eligibility | ||||||
Inclusion/exclusion criteria | × | |||||
Enrolment | × | |||||
Interventions | ||||||
MyndMove therapy | ||||||
Intensive conventional therapy | ||||||
Assessments | ||||||
Demographics and social status | × | |||||
General health history | × | |||||
History of injury event | × | |||||
Neurological | × | × | ||||
Blood pressure | × | ×* | ×* | ×* | ×* | |
Functional assessments | ||||||
SCIM | × | × | × | × | × | |
GRASSP | × | × | × | × | ||
TRI-HFT | × | × | × | |||
Participation and quality of life | ||||||
AE/SAE | × | × | × | |||
SCI-QOL | × | × | × | |||
Healthcare resource utilisation questionnaire | × | × | × | × | ||
End of Therapy Questionnaire | × |
×*=blood pressure is only required if the measurement is deemed abnormal or up to investigator’s discretion.
AE, adverse event; GRASSP, Graded Redefined Assessment of Strength, Sensibility and Prehension; SAE, serious adverse event; SCIM, Spinal Cord Independence Measure III; SCI-QOL, Spinal Cord Injury-Quality of Life; TRI-HFT, Toronto Rehab Institute Hand Function Test.