Sosnoff 2015.
Methods | Single‐blinded randomised controlled trial. Allocation by computer generated numbers with a 1:1:1:1 ratio. | |
Participants | n = 37 Randomized: Ex + Ed = 8, Ex = 11, Ed = 9, C = 9 Analysed: Ex + Ed = 8, Ex = 10, Ed = 8, C = 8 No statistically significant difference between groups at baseline MS duration (in years) was greater in the C (19 +/‐ 9.3) & Ex + Ed (20 +/‐ 7.4) groups, compared to the Ex (15 +/‐ 5.6) & Ed (14.6 +/‐ 10.9) groups |
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Interventions | Ex: Standard set of progressive exercises for balance, lower limb & trunk strength & stretching, performed at home, 3 times/week for 12 weeks, with 4 clinic visits for guidance Ed: Group education led by trained interventionist involving self‐management & self‐efficacy enhancement techniques. 1 hour, 4 times over 12 weeks Ex + Ed: Combination of Ex & Ed groups C: No intervention, wait‐list control |
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Outcomes | Number of fallers, adverse events, fall prevention strategy, physiological profile assessment | |
Notes | Ex: Exercise, Ed: Education, Ex + Ed: Exercise and Education, C: Control, PPA: Physiological Profile Assessment | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “After baseline assessment, participants were randomised into groups (exercise, education, exercise plus education, and control) using a simple randomisation method with a 1:1:1:1 allocation ratio (independent of baseline assessment) by computer generated random numbers" |
Allocation concealment (selection bias) | Low risk | “Group allocation for each participant was concealed in opaque envelopes” |
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 | Low risk | “The outcome assessors were blinded to group allocation” |
Incomplete outcome data (attrition bias) All outcomes | Low risk | "Three participants withdrew and were not included in analysis. The reasons are reported clearly, are acceptable and do not suggest bias" |
Selective reporting (reporting bias) | High risk | Stusy is lacking detail on the falls incidence data in the trial groups, with only the p‐value reported. In addition, some planned outcomes, outlined in the trial registration (NCT01956227), are not reported in the trial paper, including timed 25ft walk at 3 months, 6MWT at 3 months, TUG at 3 months, BBS at 3 months, ABC at 3 months |
Other bias | Unclear risk | No sample size calculated and inferential statistics calculated. Study may be exposed to a type II error |