Monticone 2018.
Study characteristics | ||
Methods | Randomised controlled trial | |
Participants | Scientific Institute of Lissone of the Clinical and Scientific Institutes Maugeri Period of study: July 2012 to December 2015 52 participants Inclusion: internal fixation due to extracapsular hip fractures, such as trochanteric, subtrochanteric, pertrochanteric, intertrochanteric, basal and lateral femoral fractures, 7 to 10 days before admission to rehabilitation unit; good understanding of Italian, age > 70 years Exclusion: previous hip and lower limb surgery, systemic illness, cognitive impairment (Mini Mental State Examination < 24), recent myocardial infarctions, cerebrovascular events, chronic lung or renal diseases Age: mean (SD) 77.45 (7.0) % male: 29 Number lost to follow‐up: 3 weeks = 2, 12 months = 5 | |
Interventions | 1. Intervention: individual sessions, 90‐minute sessions, 5 times a week for 3 weeks, in‐hospital programme. Balance task‐specific exercises while standing (open and closed eyes, aiming for symmetrical leg loading, proprioceptive pillows under feet, shrinking the support base, or maintaining the tandem position). Walking on a rectilinear trajectory while changing speed and direction, or while performing motor‐cognitive tasks. Additional exercises included moving from a sitting to a standing position, ascending/descending stairs and climbing obstacles. versus 2. Control: individual sessions, 90‐minute sessions, 5 times a week for 3 weeks, in‐hospital programme. Open kinetic chain exercises in the supine position aimed at improving range of hip motion, increasing hip and lower limb muscle strength, and maintaining the length and elasticity of thigh tissues. Both groups: gait training with crutches, ergonomic advice Intervention and control delivered by 1 physiatrist and 2 physiotherapists (i.e. 2 physiatrists and 4 physiotherapists total) |
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Outcomes | Assessments after randomisation, 3 weeks (used in analysis) and 12 months Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (3 subscales: physical function (primary outcome), pain and stiffness). Subscales scored 0 (best) to 100 (worst health status). Italian version Pain intensity: 0 to 10 rating scale Italian Berg Balance Scale Functional Independence Measure Short Form‐36 (subscales reported in paper) Global Perceived Effect Scale at end of treatment |
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Notes | Funding: nil Conflict of interest: nil |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "The principal investigator randomized the subjects to one of the two treatment programmes using a list of blinded treatment codes, generated in MATLAB" |
Allocation concealment (selection bias) | Low risk | "An automatic assignment system made in MATLAB to conceal the allocation" |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Therapists were not blinded. Attempts were made to blind participants. Quote: "The physiatrists, the physiotherapists and the patients were not blinded. To partially limit expectation bias and to reduce problems of crossover, patients were not made aware of the study’s hypothesis and were told that the trial was intended to compare two common approaches to hip fractures postsurgical rehabilitation, whose efficacy had not yet been established". |
Blinding of outcome assessment (detection bias) Observer‐reported outcomes, some judgement | High risk | Blinding of the secretarial staff collecting data was not specified. Effect of any non‐blinding is unknown; however, baseline assessment was conducted after randomisation, which increases risk of bias. Quote: "The principal investigator obtaining and assessing the data and the biostatistician making the analyses were both blinded to the treatment allocation". However, the paper states it was secretarial staff that collected the data. |
Blinding of outcome assessment (detection bias) Observer‐reported outcomes, no judgement | Unclear risk | "Using a specific form, the patients were asked to report any serious and/or distressing symptoms they experienced during the study that required further treatment". Blinding of the secretarial staff collecting data was not specified. Effect of apparent non‐blinding on adverse event outcomes is unclear |
Incomplete outcome data (attrition bias) Observer‐reported outcomes, some judgement | Low risk | Less than 20% of outcome data missing (8% missing, with 2/26 lost to follow‐up in intervention group and 3/26 in control group) |
Incomplete outcome data (attrition bias) Death, re‐admission, re‐operation, surgical complications, return to living at home | Low risk | Less than 20% of outcome data missing (8% missing, with 2/26 lost to follow‐up in intervention group and 3/26 in control group) |
Selective reporting (reporting bias) | Low risk | All outcomes in trial registration and methods section are reported |
Free from baseline imbalance bias? | Low risk | No indication of baseline imbalance bias |
Free from performance bias due to non‐trial interventions? | Low risk | Intervention and control delivered by equally experienced physiatrists and physiotherapists |