Hesse 2005

Methods	RCT Method of randomisation: participant drew a lot out of the sealed envelope presented by an independent person
Participants	Country: Germany Sample size: 44 participants (22 in treatment group, 22 in control group) Inclusion criteria: first‐time supratentorial stroke; stroke interval before study onset 4 to 8 weeks; severe arm paresis with no or only a palpable volitional activity of the wrist and finger extensors (i.e. MRC 0 or 1); an initial Fugl‐Meyer arm motor score (0 to 66) of less then 18; absent or moderate elbow, wrist, and finger spasticity; able to understand the meaning of the study; and written informed consent to participate in the approved study Exclusion criteria: apraxia (i.e. 1 fault in the tasks waving goodbye, saluting, and making a fist with the non‐affected hand after verbal instruction and demonstration, and using an eraser, comb, and screwdriver with the objects handed to the person and verbally instructed); shoulder pain insensitive to standard therapy; hand swelling sufficient to prevent fist formation; painful arthritis of the wrist or finger joints; and forearm skin ulcers
Interventions	2 groups: control group received in addition to their standard inpatient rehabilitation programme 5 times a week for 6 weeks (if possible EMG‐initiated) functional electrical stimulation for wrist extension experimental group received in addition to their standard inpatient rehabilitation programme for the same time and frequency as the control group therapy with the Bi‐Manu‐Track robotic arm trainer
Outcomes	Outcomes were recorded at baseline and after 6 weeks and 3 months later FMA (0 to 66) MRC score (0 to 5) muscle strength of the shoulder abductors, flexors, and extensors of the elbow, the wrist, the fingers, and the thumb. A total MRC sum score (0 to 45) included a proximal (MRC proximal subscore) (0 to 15) and a MRC distal subscore (0 to 30) MAS (0 to 5) assessed the tone of the shoulder adductors, the flexors of the elbow, wrist, fingers, and the thumb. A total MAS score (0 to 25), a proximal MAS score (0 to 10), and a distal MAS score (0 to 15) were calculated
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Sequence generation was done by shuffling envelopes
Allocation concealment (selection bias)	Low risk	Using sealed envelopes
Blinding of outcome assessment (detection bias) All outcomes	Low risk	A blinded therapist rated the videos of all participants
Selective reporting (reporting bias)	Low risk	Study protocol is available and all of the study’s prespecified (primary and secondary) outcomes that are of interest in the review have been reported in the prespecified way