| Methods |
Design: Randomised controlled trial, parallel groups.
Randomisation: No specific statement about randomisation process was provided apart from 'randomly assigned' in the abstract. However it was stated in the paper that if participants withdrew from the study then the next participant recruited would be allocated to the assigned group of the last participant to withdraw.
Dropouts: 46 participants initially enrolled in the study of which 28 completed the treatment protocol, 14 in the experimental and 14 in the control group. 18 participants were excluded from the study because: (1) pain or discomfort from surface stimulation (7 experimental and 1 control); (2) pulmonary embolism and MI (1 control); (3) new onset seizure (1 control); (4) chest pain (1 experimental); did not finish treatment protocol and declined further treatment (3 experimental and 2 control); (5) possible further hemiparesis (1 control); (6) unable to stimulate without motor activation (1 control). |
| Participants |
46 participants recruited to study.
Experimental: completed n = 14, 7% female and 5 % right hemiparesis. Mean age 59.4 (SD 11.1) years. Mean time after stroke 13.6 (SD 7.1) days).
Control: completed n = 14, 8% female and 8% right hemiparesis. Mean age 60 (SD 15.1). Mean time after stroke 17.8 (SD 5.9) days.
Study criteria: (1) stroke survivors admitted to an acute inpatient rehabilitation service within 4 weeks of unilateral stroke; (2) aged 18 years or older; (3) no potentially fatal cardiac arrhythmias; (4) no demand cardiac pacemaker; (5) no seizures in the 2 years before admission; (6) no active reflex sympathetic dystrophy; (7) no prior stroke with residual motor weakness; (8) no lower motor lesion of the impaired upper extremity; (9) no spinal cord injury; (10) no traumatic brain injury; (11) no multiple sclerosis; (12) no Parkinson's disease. |
| Interventions |
Duration: 15 sessions
Experimental:
Category = 7.
15 sessions of stimulation of the extensor digitorum communis and extensor carpi radialis. Intensity set to produce full wrist and finger extension with a duty cycle of 10 seconds on, 10 seconds off. A symmetric biphasic waveform with amplitude ranging between 0 and 60 mA, a pulse width of 300ms, frequency between 25 and 50 Hz and a ramp up and down time of 2 seconds each. The current amplitude and stimulus frequency were set to participant comfort. All experimental participants also received standard physiotherapy, occupational therapy and speech and language therapy routine to the inpatient facility.
Control: 15 sessions of surface stimulation but with electrodes placed away from all motor points. Stimulation produced only cutaneous stimulation just beyond sensory threshold and without any motor activation. All experimental participants also received standard physiotherapy, occupational therapy and speech and language therapy routine to the inpatient facility.
Comparison: Electrostimulation vs placebo. |
| Outcomes |
Baseline measurement: Pre‐intervention.
Outcome measurement: After 15 sessions of the intervention.
Included outcomes: (1) Fugl‐Meyer Upper Extremity Score; (2) FIM self‐care section. |
| Notes |
Intention‐to‐treat principle not followed in analysis. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
High risk |
C ‐ Inadequate |
