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Trials
Published in: Trials 1/2011

Open Access 01-12-2011 | Study protocol

Early intensive hand rehabilitation after spinal cord injury ("Hands On"): a protocol for a randomised controlled trial

Authors: Lisa A Harvey, Sarah A Dunlop, Leonid Churilov, Ya-Seng Arthur Hsueh, Mary P Galea

Published in: Trials | Issue 1/2011

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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/design

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.

Discussion

The results of this trial will determine the effectiveness of an 8-week program of intensive hand training with functional electrical stimulation.

Trial registration

NCT01086930 (12th March 2010)
ACTRN12609000695​202 (12th August 2009)
Appendix
Available only for authorised users
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Metadata
Title
Early intensive hand rehabilitation after spinal cord injury ("Hands On"): a protocol for a randomised controlled trial
Authors
Lisa A Harvey
Sarah A Dunlop
Leonid Churilov
Ya-Seng Arthur Hsueh
Mary P Galea
Publication date
01-12-2011
Publisher
BioMed Central
Published in
Trials / Issue 1/2011
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-12-14

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