Carling 2017.
Methods | Multi‐centre single‐blinded randomised controlled pilot study, computerised random allocation with varied block sizes | |
Participants | n=51, Randomised: (E=25, C=26), Anaylsed (E=23, C=25) Groups differed at baseline for age, gender and MS subtype ‐ E group older, higher proportion of females and no participants with relapsing remitting MS |
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Interventions | Core stability exercise, dual tasking and sensory strategies individualised and progressed by physiotherapists in groups of 2‐5. 14 sessions over 7 weeks, 60 minute per session. 2‐5 individualised and progressive home exercises, twice a week |
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Outcomes | Number of falls per group, number of fallers, number of multiple fallers, Fatigue, trunk impairment, timed sit‐to‐stand, postural sway, balance function, falls efficacy, walking mobility, timed mobility, walking velocity | |
Notes | E: Exercise, C: Control, BBS: Berg Balance Scale, ES: Effect Size, MSWS: Multiple Sclerosis Walking Scale | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | An external statistician conducted a computerized random allocation sequence with varied block sizes |
Allocation concealment (selection bias) | Low risk | Concealed allocation was achieved using sealed envelopes, which were opened right after baseline measure by the physiotherapist in charge at each site |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not outlined in paper that participants or healthcare providers were blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Raters blinding was accomplished with the raters travelling to different centres, unaware of allocation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Three were lost to follow‐up, (early intervention group= 2 due to fall‐related fracture; 1 in late intervention group due to lost to follow‐up) |
Selective reporting (reporting bias) | Low risk | Compared with planned outcome reporting outlined in the registered trial (NCT 02209467) all outcomes are reported in the trial |
Other bias | Low risk | Sample size calculated a priori and required number of participants recruited. |