Bale 2008.
Study characteristics | ||
Methods | Study design: RCT Method of randomisation: "Patients who volunteered and gave written informed consent were randomly allocated to two different training groups, either a functional strength training group or a training‐as‐usual group by drawing lots. From a total number of 20, 10 were allotted to each training group" |
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Participants | Number of participants: n = 18 Inclusion criteria: first onset of stroke with reduced muscle strength in the affected leg, ability to understand verbal information, able to sit without support Exclusion criteria: significant sensory or cognitive sequelae, arrhythmia, uncontrolled angina pectoris or hypertension or co‐morbidities that could mask the sequelae from the stroke and patients with no motor control of the affected leg |
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Interventions | (1) Functional strength training (intervention) group (n = 8) "Had training to improve the muscle strength of the lower extremities three days a week, and trained arm functions and activities of daily living the remaining two days. The functional strength training programme was designed to facilitate appropriate power in the weak muscles of the affected leg in graded activities or sequences of activities. Most of the exercises were weight‐bearing and also challenged standing balance" The exercises are well described in the appendix—including strength training exercises such as step‐ups, standing, sit‐to‐stand‐to‐sit, heel and toe rises and bridging "Each strengthening exercise was performed according to the principle of 10 to 15 repetitions maximum to achieve moderate fatigue in one set" "The patients trained in ADLs such as walking, sitting‐to‐standing, stair climbing, etc. if time permitted after the strengthening exercises" The individual components delivered are listed in Table 6. Based on the individual components, this intervention is categorised as comprising functional task training and musculoskeletal intervention (active) Length of intervention period: four weeks Number of sessions and length of individual sessions: 50 minutes/d five days a week Intervention provider: different physiotherapists trained participants in the two intervention groups (2) Training as usual (comparison) group (n = 10) "The patients in the training‐as‐usual group had traditional training influenced by the Bobath Concept, with a central focus on normalizing muscle tone and movements on the affected side, symmetrical use of the body and relearning activities of daily living, often using manual guiding and facilitation techniques. Use of excessive muscle power was avoided to prevent associated reactions during training" "As part of their basic rehabilitation, all patients participated in multidisciplinary training programmes. Questionnaires were filled in by nurses and occupational therapists at week 3 of each patient’s training period to obtain information about attendance and quantity of training in the wards, and in sessions with occupational therapists" The individual components delivered are listed in Table 6. Based on the individual components, this intervention is categorised as comprising functional task training and neurophysiological intervention Length of intervention period: four weeks Number of sessions and length of individual sessions: 50 minutes/d five days a week Intervention provider: Different physiotherapists trained participants in the two intervention groups This study is classified as active intervention one (functional task training, musculoskeletal (active)) versus active intervention two (functional task training, neurophysiological) (Table 9) |
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Outcomes | Measures of motor function: Motor Assessment Scale Measures of voluntary movement: gait speed over 12 metres Measures of muscle strength: dynamometer measures of knee extension and flexion Other secondary outcome measures: maximum weight bearing, Patient Global Impression of Change Time points when outcomes were assessed: at inclusion and after four weeks |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Randomly allocated to two different training groups, either a functional strength training group or a training‐as‐usual group by drawing lots" |
Allocation concealment (selection bias) | Unclear risk | Not enough information provided |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Two physiotherapists performed the physical measurements, and were blinded to the patients’ group assignment. Before the study started, the testers were trained to perform the measurements based on a test protocol. To improve reliability they tested four patients independently at the same time, and discussed their scores afterwards" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts |
Free of systematic differences in baseline characteristics of groups compared? | Low risk | "At inclusion there were no statistical significant differences between the groups, neither in demographic variables nor in physical performance measures" |
Did authors adjust for baseline differences in their analyses? | Low risk | No information provided |
Other bias | Unclear risk | No information provided |