Early intensive hand rehabilitation is not more effective than usual care plus one-to-one hand therapy in people with sub-acute spinal cord injury ('Hands On'): a randomised trial.

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.