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. 2020 Sep 28;10(9):e039650. doi: 10.1136/bmjopen-2020-039650

Table 2.

A summary of assessments and data collection

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.