Duncan 2003.
Study characteristics | ||
Methods | Study design: RCT Method of randomisation: blocked randomisation (block size six), random number generator and sealed envelopes | |
Participants | Number of participants: n = 100
Inclusion criteria: stroke within 30 to 150 days, able to walk 25 m independently, mild to moderate stroke deficits, MMSE greater than 16 Exclusion criteria: subarachnoid haemorrhage, lethargic, obtunded or comatose; uncontrolled blood pressure, hepatic or renal failure, NYHA III/IV heart failure, known limited life expectancy or prestroke disability in self care and lived in a nursing home before the stroke |
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Interventions | (1) Mixed group (n = 50) Exercise programme at home aimed at improving strength, balance, endurance, upper limb use Included a variety of techniques from different theoretical 'approaches' Techniques included ROM (range of movement exercises), PNF (proprioceptive neuromuscular facilitation), task‐specific training Structured protocols for the exercise tasks, criteria for progression and guidelines for reintroducing therapy after intercurrent illness The individual components delivered are listed in Table 6. Based on the individual components, this intervention is categorised as comprising cardiopulmonary interventions, functional task training, musculoskeletal interventions (active) and neurophysiological interventions Length of intervention period: 12 to 14 weeks Number of sessions and length of individual sessions: 36 sessions of 90 minutes Intervention provider: supervised by physiotherapist or occupational therapist (2) Control group (n = 50) Usual care: Participants in the usual care group had services as prescribed by their physicians. Treating therapists for usual care participants completed a treatment log. "In the usual care group, 46% of the subjects did not receive any postacute rehabilitation services from physical or occupational therapy. Two thirds were provided recommendations for an unsupervised exercise program. Among the usual care group members who did receive therapy, participants received an average of 8.7 (SD 5.3) physical therapy visits and 10.4 (SD 7.1) occupational therapy visits. Physical and occupational therapy services were received separately as prescribed by their physicians" The therapy that participants received was primarily directed at strength, balance, endurance, upper extremity, range of motion, mobility and ADL/IADL The individual components delivered are listed in Table 6. Based on the individual components, this intervention is categorised as comprising usual care (functional task training, musculoskeletal intervention (active)) Length of intervention period: varied Number of sessions and length of individual sessions: visited by researcher every two weeks Intervention provider: physiotherapists and occupational therapists This study was classified as intervention (functional task training, musculoskeletal interventions (active) and neurophysiological interventions) versus usual care (functional task training, musculoskeletal (active)) (Table 8). The intervention group also received cardiopulmonary intervention |
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Outcomes | Measures of functional independence: Fugl‐Meyer (LL)
Measures of postural control and balance: Berg Balance Scale score
Measures of voluntary movement: gait velocity
Measures of muscle strength: ankle and knee strength Time points when outcomes were assessed: "primary outcomes of the study were assessed at 3 months, immediately after the intervention" |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Blocked randomisation (block size six), random number generator and sealed envelopes "After baseline assessments, the subjects were randomly assigned to the intervention or control group through the use of a random number generator with a block size of 6 and sealed envelopes" |
Allocation concealment (selection bias) | Low risk | No information provided |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The assessor was blinded "Outcome assessment was performed by research staff blinded to treatment assignment. Participants were instructed to avoid mentioning anything regarding their study experience to the assessors. Participants were not blinded to their assignment but were unaware of the study hypotheses or primary outcome measures" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Dropouts accounted for 92/100 completed intervention and three‐month follow‐up |
Free of systematic differences in baseline characteristics of groups compared? | Low risk | No significant differences in baseline characteristics of intervention, control and dropout groups except on the Wolf Motor Function test ("significantly different in those who did vs did not drop out") |
Did authors adjust for baseline differences in their analyses? | Low risk | No information provided |
Other bias | High risk | Participants in the intervention group received greater contact with therapists than participants in the control group, providing a potential source of performance bias. However, 54% of the control group did receive rehabilitation from physiotherapists and occupational therapists during the study period. This 'usual care' may have made the control and treatment groups similar in the rehabilitation they received, potentially reducing the effect of the intervention |