ABSTRACT
Question: What is the effect of adding an intensive task-specific hand-training program involving
functional electrical stimulation to a combination of usual care plus three 15-minute sessions per week of
one-to-one hand therapy in people with sub-acute tetraplegia? Design: A parallel group, randomised,
controlled trial. Participants were randomly assigned (1:1) via a computer-generated concealed block
randomisation procedure to either a control or experimental intervention. Participants: Seventy people
with C2 to T1 motor complete or incomplete tetraplegia within 6 months of injury. Participants were
recruited from seven spinal units in Australia and New Zealand. Intervention: Experimental participants
received intensive training for one hand. Intensive training consisted of training with an instrumented
exercise workstation in conjunction with functional electrical stimulation for 1 hour per day, 5 days per
week for 8 weeks. Both groups received usual care and 15 minutes of one-to-one hand therapy three times
per week without functional electrical stimulation. Outcome measures: The primary outcome was the
modified Action Research Arm Test reflecting arm and hand function, which was assessed at the end of the
intervention, that is, 11 weeks after randomisation. Secondary outcomes were measured at 11 and
26 weeks. Results: Sixty-six (94%) participants completed the post-intervention assessment and were
included in the primary intention-to-treat analysis. The mean modified Action Research Arm Test score for
experimental and control participants at the post-intervention assessment was 36.5 points (SD 16.0) and
33.2 points (SD 17.5), respectively, with an adjusted mean between-group difference of 0.9 points (95% CI –
4.1 to 5.9). Conclusion: Adding an intensive task-specific hand-training program involving functional
electrical stimulation to a combination of usual care plus three 15-minute sessions per week of one-to-one
hand therapy does not improve hand function in people with sub-acute tetraplegia. Registration:
Australian and New Zealand Trial Registry ACTRN12609000695202 and ClinicalTrials.gov NCT01086930.
[Harvey LA, Dunlop SA, Churilov L, GaleaMP, Spinal Cord Injury Physical Activity (SCIPA) Hands On Trial
Collaborators (2016) Early intensive hand rehabilitation is notmore effective than usual care plus oneto-one
hand therapy in people with sub-acute spinal cord injury (‘Hands On’): a randomised trial.
Journal of Physiotherapy 62: 88–95]