Taylor 2014.
Methods | Single‐blinded randomised crossover trial. | |
Participants | n = 25 Randomized: FES = 11, C = 14 Analysed: FES = 9, C = 11 No statistically significant difference between groups for baseline characteristics, although there was a higher proportion of walking aid users in C |
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Interventions | FES: The ODFS for perineal stimulation worn for 6 weeks, gluteal stimulation added from week 6. At week 12 core stability exercises weekly in clinic to week 18. Exercises continued at home till week 24 C: No intervention, wait list control |
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Outcomes | Gait analysis, 10m walk speed, MS impact (physical and psychological), falls rate | |
Notes | FES: Functional Electrical Stimulation, C: Control, ODFS: Oddstock Drop Foot Stimulator, ROGA: Rivermead Observational Gait Analysis | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization was performed using computer generated random numbers and group allocations were held by an independent medical statistician |
Allocation concealment (selection bias) | Unclear risk | Insufficient information available to permit a judgement of ‘low risk’ or ‘high risk’ |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Insufficient information available to permit a judgement of ‘low risk’ or ‘high risk’ |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding of outcome assessors is not outlined in the paper. To this end, Insufficient information available to permit a judgement of ‘low risk’ or ‘high risk’ except for the ROGA |
Incomplete outcome data (attrition bias) All outcomes | High risk | Only volunteers who completed the protocol were included in the analysis.” There is discrepancy in the flow of participants throughout the trial‐ text on pg 77 outlines that 28 people were recruited, however, figure 3 demonstrates that 27 participants were enrolled. Of the 25 randomised participants, 5 participants withdrew for different reasons |
Selective reporting (reporting bias) | Unclear risk | No registered protocol was referenced in the paper so it is difficult to assess reporting bias |
Other bias | Unclear risk | Potential risk of bias introduced as the intervention delivery mechanism (the Odstock Drop Foot Stimulator) is produced by a company owned by some of the authors‐ however, this potential conflict of interest is outlined by the authors. No sample size calculated and inferential statistics calculated. Study may be exposed to a type II error |