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A Pilot Study to Investigate the Combined Use of Botulinum Neurotoxin Type A and Functional Electrical Stimulation, with Physiotherapy, in the Treatment of Spastic Dropped Foot in Subacute Stroke
Author(s) -
Johnson Catherine A.,
Wood Duncan E.,
Swain Ian D.,
Tromans Anthony M.,
Strike Paul,
Burridge Jane H.
Publication year - 2002
Publication title -
artificial organs
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.684
H-Index - 76
eISSN - 1525-1594
pISSN - 0160-564X
DOI - 10.1046/j.1525-1594.2002.06948.x
Subject(s) - medicine , randomized controlled trial , functional electrical stimulation , physical therapy , spastic , physical medicine and rehabilitation , transcutaneous electrical nerve stimulation , stroke (engine) , stimulation , cerebral palsy , surgery , mechanical engineering , alternative medicine , pathology , engineering
The objective was to inform sample size calculations for a full randomized controlled trial (RCT). The design included an RCT pilot trial with a 16 week study period, including a 4 week baseline phase. The subjects were adults within 1 year of first stroke, ambulant with a spastic dropped foot. Twenty‐one participants were recruited from the stroke services of 4 centers. For intervention all participants received physiotherapy; the treatment group also received botulinum neurotoxin Type A (BoNTA) intramuscular injections to triceps surae (800 U Dysport) and functional electrical stimulation (FES) of the common peroneal nerve to assist walking. The main outcome measure was walking speed. The result was a significant upward trend in median walking speed for both the control (p = 0.02) and treatment groups (nonstimulated p = 0.004, stimulated p = 0.042). Trend lines were different in location (p = 0.04 and p = 0.009, respectively). In conclusion, there is evidence of an additional, beneficial effect of BoNTA and FES. Sufficient information has been gained on the variability of the primary outcome measure to inform sample size calculations for a full RCT to quantify the treatment effect with precision.