Study characteristics |
Methods |
RCT |
Participants |
Setting: Wisconsin, USA
N = 113
Sample: recruited from fall registry and by single media release (60% women)
Age (years): mean 74.2, range 65 to 96
Inclusion criteria: aged ≥ 65 years; community‐dwelling; ≥ 1 falls in previous year; independently ambulatory
Exclusion criteria: not capable of applying Yaktrax walker correctly or discerning correct outdoor conditions to wear them |
Interventions |
1. Yaktrax walker (netting applied over usual footwear with wire coils to increase grip in winter outdoor conditions)
2. Control: usual winter footwear |
Outcomes |
1. Rate of falls |
Duration of the study |
3 months ("one winter") |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Quote: "randomized" |
Allocation concealment (selection bias) |
Unclear risk |
Insufficient information to permit judgement |
Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Consent to participate included awareness of the intervention, and the absence of intervention. 19% of individuals in control group used the intervention device. |
Blinding of outcome assessment (detection bias)
Falls and fallers |
Unclear risk |
Falls reported by participants who were aware of their group allocation, using monthly calendars. Blinding of research staff not described. |
Incomplete outcome data (attrition bias)
Falls |
Low risk |
SeeAppendix 3 for method of assessment |
Risk of bias in recall of falls |
Low risk |
Prospective. Fall diary returned by post. |