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. 2006 Apr 19;2006(2):CD003241. doi: 10.1002/14651858.CD003241.pub2

Burridge 1997.

Methods Design: Randomised controlled trial, parallel group 
 Randomisation: Block randomisation. Before recruitment of participants a list of 34 numbers were randomly allocated to experimental or control. List not held by researchers and allocated to groups as recruited to study. 
 Dropouts: None reported.
Participants n = 32. 
 Participants recruited from consultants, GP and physiotherapy referrals. 
 Some participants referred themselves after reading an article in the 'Independent' newspaper. 
 Experimental: n = 16, 10 male and 9 right hemiparesis. Mean age was 52 years 3 months (SD 14 years 3 months) and a mean time after stroke of 3 years 7 months. 
 Control: n = 16, 13 male and 8 right hemiparesis. Mean age was 61 years 3 months (SD 8 years 6 months) and mean time after stroke was 4 years 11 months. 
 Study criteria: (1) hemiplegia of at least 6 months duration; (2) a single foot drop as a result of a CVA; (3) sufficient dorsiflexion of the ankle with electrical stimulation to enable heel strike when walking and without undue discomfort; (4) unimpaired cognition; (5) understanding of the use of the device; (6) positive motivation; (7) able to stand unsupported and able to walk 10 metres (walking aids allowed but not use of another person); (8) able to stand from sitting without help and walk a minimum of 50 metres before the CVA; (9) no other medical conditions severe enough to impair walking; (10) no hypersensitivity to the sensation of the stimulation.
Interventions Duration: 4/5 weeks (1 month). 
 Experimental: 
 Category = 7. Electrical stimulation was provided externally to the common peroneal nerve to produce tibialis anterior contraction during the swing phase of gait. The level of stimulation was controlled by the participants who were taught to adjust this to achieve an effective heel strike. Experimental participants were also provided with 10, 1‐hour physiotherapy sessions given over a 1‐month period by Bobath‐trained therapists but some of this time was spent adjusting stimulation parameters 
 Control: 
 The control therapy was 10, 1‐hour physiotherapy sessions given over 1‐month by Bothath‐trained physiotherapists. 
 Comparison: Electrostimulation vs no treatment.
Outcomes Baseline measurement: before intervention began. 
 Outcome measurement: At end of 4/5 week (1 month) intervention period. 
 Included outcomes: (1) walking speed without stimulation; (2) physiological cost index without stimulation; (3) Wartenberg pendulum test relaxation index for hemiplegic leg 
 Other outcomes: (1) walking speed with stimulation for experimental and without stimulation for control group; (2) physiological cost index with stimulation for experimental group and without stimulation for control group; (3) Wartenberg pendulum test area under the curve for hemiplegic leg.
Notes One of the study criteria excluded potential participants who had no observed improvement in walking with stimulation.
The co‐intervention for the experimental group was not identical to that provided for the control group as it included adjusting the stimulation parameters for best dorsiflexion effect and not just provision of conventional physical therapy.
We excluded the outcome comparison of the experimental group walking with electrostimulation and control group walking without stimulation but included the outcome comparison of the experimental group walking without electrostimulation and control group walking without stimulation. This decision was taken to match the measurement conditions of the experimental and control group as it remains a possibility that the walking ability of the control group might have been better with electrostimulation than it was without it.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? High risk C ‐ Inadequate