title: Early intensive hand rehabilitation after spinal cord injury ("Hands On"): a protocol for a randomised controlled trial.
abstract: BACKGROUND
  Loss of hand function is one of the most devastating consequences of spinal cord injury. Intensive hand training provided on an instrumented exercise workstation in conjunction with functional electrical stimulation may enhance neural recovery and hand function. The aim of this trial is to compare usual care with an 8-week program of intensive hand training and functional electrical stimulation.
  
  
  METHODS
  A multicentre randomised controlled trial will be undertaken. Seventy-eight participants with recent tetraplegia (C2 to T1 motor complete or incomplete) undergoing inpatient rehabilitation will be recruited from seven spinal cord injury units in Australia and New Zealand and will be randomised to a control or experimental group. Control participants will receive usual care. Experimental participants will receive usual care and an 8-week program of intensive unilateral hand training using an instrumented exercise workstation and functional electrical stimulation. Participants will drive the functional electrical stimulation of their target hands via a behind-the-ear bluetooth device, which is sensitive to tooth clicks. The bluetooth device will enable the use of various manipulanda to practice functional activities embedded within computer-based games and activities. Training will be provided for one hour, 5 days per week, during the 8-week intervention period. The primary outcome is the Action Research Arm Test. Secondary outcomes include measurements of strength, sensation, function, quality of life and cost effectiveness. All outcomes will be taken at baseline, 8 weeks, 6 months and 12 months by assessors blinded to group allocation. Recruitment commenced in December 2009.
  
  
  CONCLUSIONS
  The results of this trial will determine the effectiveness of an 8-week program of intensive hand training with functional electrical stimulation.
  
  
  BACKGROUND
  NCT01086930 (12th March 2010)ACTRN12609000695202 (12th August 2009).
authors.affiliation: Rehabilitation Studies Unit, Northern Clinical School, Sydney School of Medicine, University of Sydney, PO Box 6, Ryde, NSW, 1680, Australia. l.harvey@usyd.edu.au
authors.forename: Lisa A
authors.initials: LA
authors.lastname: Harvey
authors.forename: Sarah A
authors.initials: SA
authors.lastname: Dunlop
authors.forename: Leonid
authors.initials: L
authors.lastname: Churilov
authors.forename: Ya-Seng Arthur
authors.initials: YS
authors.lastname: Hsueh
authors.forename: Mary P
authors.initials: MP
authors.lastname: Galea
mesh_terms: D001315:Australia; D003131:Combined Modality Therapy; D003362:Cost-Benefit Analysis; D004185:Disability Evaluation; D004599:Electric Stimulation Therapy / Q000191:economics; D006225:Hand / Q000294:innervation*; D017048:Health Care Costs; D006801:Humans; D009043:Motor Activity; D053580:Muscle Strength; D009460:Neurologic Examination; D009520:New Zealand; D026741:Physical Therapy Modalities / Q000191:economics; D011782:Quadriplegia / Q000175:diagnosis / Q000191:economics / Q000503:physiopathology / Q000534:rehabilitation*; D011788:Quality of Life; D020127:Recovery of Function; D012107:Research Design; D013119:Spinal Cord Injuries / Q000175:diagnosis / Q000191:economics / Q000503:physiopathology / Q000534:rehabilitation*; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome