Johansson 2001.
| Methods | RCT, computer‐generated randomization C: sequentially numbered, sealed, opaque envelopes Blinding: participants and outcome assessors ITT analysis: yes Losses to FU: for BI, 6 in acupuncture group, 6 in control group | |
| Participants | Country: Sweden
99 participants (54 men, mean age 76 ± 9 years in treatment group, mean age 76 ± 11 years in control group) with acute ischemic stroke
Treatment: 48, control: 51
5 to 10 days from stroke onset
98.5% CT scan before entry Health conditions before stroke: without previous neurological, psychiatric, or other disorder, making it difficult to pursue treatment or evaluation Comparability: age, sex, medical history, CT scan finding, motor function score, and ability to walk 10 meters similar |
|
| Interventions | Treatment group: 9 to 10 acupoints (LI4, ST36, DU20, LI11, ST40, EX28:21, EX36:1, GB34), manual and/or electrical stimulation, 30 minutes/session, twice a week for 10 weeks Control group: acupoints as above, subliminal TENS (no skin sensation and no visible muscle contraction) Both groups: conventional physiotherapy, occupational therapy, speech therapy, and drug therapy if needed | |
| Outcomes | Motor function (RMI, walk speed, ability to walk 10 meters) at 3, 12 months Change in BI at 3, 12 months QOL score (NHP) at 3, 12 months Adverse events | |
| Notes | FU: 1 year | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated randomization |
| Allocation concealment (selection bias) | Low risk | Sequentially numbered, sealed, opaque envelopes |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Blinding of participants |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinding of outcome assessors |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | For BI, 6 in acupuncture group, 6 in control group lost to follow‐up |
| Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgement |
| Other bias | Unclear risk | Insufficient information to permit judgement |