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. 2011 Jun 15;2011(6):CD006609. doi: 10.1002/14651858.CD006609.pub2

Mann 2005

Methods Trial inclusions: 1 to 12 months post first stroke, medically stable, over 18 years old, able to take hemiplegic hand to mouth, sensory impairment (light touch), no previous upper limb pathology, no cardiac pacemaker in situ, able to comply with treatment and assessment procedures, able to give informed consent Trial exclusions: cognitive problems, psychiatric problems, cardiac problems, cardiac pacemaker in situ Statistical analyses performed: ANCOVA on Action Research Arm Test and sensation at 12 and 24 weeks
Participants Number of participants: 22 Mean age (years): experimental group: 68, control group: 71 Age range: experimental group: 57 to 86, control group: 57 to 87 Gender ratio (male:female): experimental group: 5:6, control group: 5:6 Site of lesion: not reported Time post stroke: experimental group: mean 8.5 months (range 1 to 12 months), control group: mean 5.7 months (range 2 to 12 months) Stroke classification: experimental group: 10 infarct:1 haemorrhagic, control group: 11 infarct
Interventions Able‐bodied group: n/a Control group: ongoing therapy continued, plus passive extension exercises of elbow, wrist and fingers daily for 30 minutes, then twice per day for 12 weeks, followed by 12 weeks without treatment Experimental group: ongoing therapy continued, plus neuromuscular stimulation, 30 minutes, twice a day for 12 weeks, then 12 weeks of no treatment
Outcomes ARAT (Lyle 1981) and 2‐point discrimination
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Low risk Sealed allocation codes
Power Calculation High risk None
Blinding of participants Unclear risk Unclear
Blinding of intervention  providers Unclear risk Unclear
Blinding of outcome assessor Unclear risk Unclear
Follow up and exclusions Unclear risk 24 participants recruited, however only 22 completed. 2 dropped out and lost to follow up without clear reason
Selective reporting and other sources of bias Unclear risk Consecutive sample
Reliability of outcome measures used Unclear risk Action Research Arm Test has previously been demonstrated as reliable. Reliability of 2‐point discrimination test unclear
Randomization method Low risk Computer‐generated sealed allocation codes