Methods | RCT Method of randomisation: blocked randomisation, using opaque envelopes |
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Participants | Country: the Netherlands Sample size: 22 Inclusion criteria: first‐ever stroke, age between 18 and 85 years, clinically diagnosed with a central paresis of the arm/hand (strength: MRC grade 2 to 4 at entry into study), poststroke time ≥ 12 months, fair to good cognitive level (Mini‐Mental State Examination score ≥ 26), able to read and understand the Dutch language, unable to fully perform at least 2 of the following skills: drinking from a cup, eating with knife and fork, taking money from a purse and using a tray, motivated to train at least 2 of the above‐mentioned skills. (At the start of the last 6 months of the inclusion period, inclusion criteria were adjusted to poststroke time ≥ 8 months, to facilitate participant inclusion) Exclusion criteria: severe neglect (Bell Test, Letter Cancellation Test: minimum omission score of 15%), hemianopsia, severe spasticity (MAS total arm > 3, severe additional neurological, orthopaedic, or rheumatoid impairments prior to stroke that could interfere with task performance, Broca's aphasia, Wernicke's aphasia, global aphasia (determined by the Akense Afasie Test), apraxia (apraxia test of Van Heugten), and attending another study or therapy to improve arm‐hand function |
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Interventions | 2 groups:
Training was provided during 8 weeks, 4 times/week, twice a day for 30 minutes (separated by 0.5 hour to 1 hour of rest) |
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Outcomes | Outcomes were recorded at baseline and post‐treatment every 2 weeks
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "participants were randomly allocated to ... using blocked randomization (block size = 2). The randomization procedure was performed by an independent researcher using 2 opaque envelopes with in each envelope a training condition code." |
Allocation concealment (selection bias) | Low risk | Quote: "The randomization procedure was performed by an independent researcher using 2 opaque envelopes within each envelope a training condition code." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Persons involved in data collection were blinded for group allocation." |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgement |