Lindenberg 2010.
| Methods | Study design: sham‐controlled double‐blinded randomised trial Dropouts: not stated Adverse effects: none Deaths: not stated, likely none ITT: not stated |
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| Participants | Country: USA Number of participants: 20 chronic stroke participants Age: (mean ± SD) 55.8 ± 12.9 years Gender: 5 female (25%) Type of stroke: first and only ischaemic stroke Time poststroke: (mean ± SD) 40.3 ± 23.4 months Severity: UE‐FM Score (mean ± SD) 39.8 ± 11.5 Inclusion criteria: ischaemic stroke in the territory of the medial cerebral artery at least 5 months before enrolment; no previous or subsequent strokes; MRC strength grade of 3/5 in extensor muscles of the lesioned upper extremity in the acute phase with at least 15 degrees of active wrist dorsiflexion at enrolment Exclusion criteria: additional neurological or psychiatric disorders; concurrent use of CNS‐affecting drugs |
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| Interventions | Number of arms: 2, each participant underwent 5 consecutive sessions of physical therapy/occupational therapy and 1 of the following interventions
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| Outcomes | Primary outcome measure: UE‐FM scores (0 to 66, with higher scores reflecting better motor performance) Secondary outcome measure: WMFT (with lower scores indicating better motor performance) Time point of measurement: at baseline and at 3 and 7 days after the last intervention session |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Patients were randomly assigned to one of two groups ... using a block randomisation with 3 strata of impairment" |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) Subjective outcome measures | Low risk | There were no subjective outcome measures |
| Blinding of participants and personnel (performance bias) Objective outcome measures | Low risk | Participants and personnel were blinded |
| Blinding of outcome assessment (detection bias) Subjective outcome measures | Low risk | There were no subjective outcome measures |
| Blinding of outcome assessment (detection bias) Objective outcome measures | Low risk | Quote: "Each patient underwent motor impairment assessments and MRI at baseline and after the intervention, conducted by trained individuals who were blinded to the type of intervention the patients received" |
| Incomplete outcome data (attrition bias) Subjective outcome measures | Low risk | There were no subjective outcome measures |
| Incomplete outcome data (attrition bias) Objective outcome measures | Unclear risk | All randomised participants apparently completed the study. No treatment withdrawals, no losses to follow‐up, no trial group changes and no major adverse events were stated |
| Selective reporting (reporting bias) | Unclear risk | All outcomes stated in the methods section were reported |