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A pilot study to investigate the combined use of botulinum toxin A and functional electrical stimulation, with physiotherapy, in the treatment of spastic dropped foot in sub-acute stroke

A pilot study to investigate the combined use of botulinum toxin A and functional electrical stimulation, with physiotherapy, in the treatment of spastic dropped foot in sub-acute stroke
A pilot study to investigate the combined use of botulinum toxin A and functional electrical stimulation, with physiotherapy, in the treatment of spastic dropped foot in sub-acute stroke
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
stroke
0160-564X
263-266
Johnson, Catherine A.
7148454f-72a8-45fc-9d75-6b57402c20c3
Wood, Duncan E.
03d805f5-6192-4fa0-846d-a42caa809231
Swain, Ian D.
d050385a-f6e3-4534-9c93-86ddd10924ef
Tromans, Anthony M.
b1d0c7eb-c25f-494f-a46f-e9f30e559d05
Strike, Paul
3c33eda8-2ba9-43ce-b66e-3d3e5003c96d
Burridge, Jane H.
0110e9ea-0884-4982-a003-cb6307f38f64
Johnson, Catherine A.
7148454f-72a8-45fc-9d75-6b57402c20c3
Wood, Duncan E.
03d805f5-6192-4fa0-846d-a42caa809231
Swain, Ian D.
d050385a-f6e3-4534-9c93-86ddd10924ef
Tromans, Anthony M.
b1d0c7eb-c25f-494f-a46f-e9f30e559d05
Strike, Paul
3c33eda8-2ba9-43ce-b66e-3d3e5003c96d
Burridge, Jane H.
0110e9ea-0884-4982-a003-cb6307f38f64

Johnson, Catherine A., Wood, Duncan E., Swain, Ian D., Tromans, Anthony M., Strike, Paul and Burridge, Jane H. (2001) A pilot study to investigate the combined use of botulinum toxin A and functional electrical stimulation, with physiotherapy, in the treatment of spastic dropped foot in sub-acute stroke. Artificial Organs, 26 (3), 263-266. (doi:10.1046/j.1525-1594.2002.06948.x).

Record type: Article

Abstract

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

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More information

Published date: 2001
Keywords: stroke

Identifiers

Local EPrints ID: 17926
URI: http://eprints.soton.ac.uk/id/eprint/17926
ISSN: 0160-564X
PURE UUID: 5242ab57-a0d4-4630-a818-856d7238f8b8
ORCID for Jane H. Burridge: ORCID iD orcid.org/0000-0003-3497-6725

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Date deposited: 18 Jun 2007
Last modified: 16 Mar 2024 02:57

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Contributors

Author: Catherine A. Johnson
Author: Duncan E. Wood
Author: Ian D. Swain
Author: Anthony M. Tromans
Author: Paul Strike

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