Johansson 2001.
| Methods | Design: Randomised controlled trial. parallel groups Randomisation: Computer generated random allocation. Allocation concealed in consecutively numbered opaque envelopes. Envelope opened by research therapist and not by local study co‐ordinator or evaluators. Dropouts: At outcome measure 3 from TENS group (1 died, 1 adverse reaction, 1 unknown) and 5 from placebo group (3 died, 1 comorbidity, 1 at patient's own request). | |
| Participants | Experimental: n = 51, 45% female. Mean age 77 (SD9) years. 48 participants completed. Control: n = 51, 51% female. Mean age 76 (SD 11) years. 46 participants completed. Study criteria: (1) acute stroke 5 to 7 days before randomisation; (2) if recurrent stroke then no functional impairment before the present event; (3) Barthel Index 70 or less in combination with the inability to perform Nine Hole Peg Test within 60 seconds or inability to walk 10 metres without an aid or person support; (4) no previous neurological, psychiatric or other disorder making it difficult to pursue treatment or evaluations; (5) ability to comprehend information about the trial; (6) no concurrent participation in another trial of interventions supposed to affect neurological and functional outcome. | |
| Interventions | Duration: 30 minutes, twice a week for 10 weeks. Experimental: Category = 8 High‐intensity, low‐frequency (2Hz) TENS. The amplitude was strong enough to produce visible muscle contractions. All experimental participants also received conventional physiotherapy, occupational therapy and speech and language therapy if needed. Control: Subliminal high‐intensity, low‐frequency TENS. No skin sensation and no visible muscle contractions. All control participants also received conventional physiotherapy, occupational therapy and speech and language therapy if needed. Comparison: electrostimulation vs placebo. | |
| Outcomes | Baseline measurement: Randomisation. Outcome measurement: 3 months after stroke. Included outcomes: (1) Rivermead Mobility Index; (2) walking speed; (3) Barthel Index. Other outcomes: (1) ability to walk 10 metres; Nottingham Health profile quality of life domains. | |
| Notes | This was a 3‐group study but only 2 groups were included in this review. The acupuncture group was excluded because the control group was better matched to the other experimental group. Intention‐to‐treat principle was followed in data analysis. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment? | Low risk | A ‐ Adequate |