Wiart 1997.
| Methods | RCT Setting: France |
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| Participants | 22 people within 3 months onset of stroke and severe left unilateral neglect, hospitalised in 2 neurorehabilitation hospitals, positive for neglect on 3 tests (see Outcomes) Experimental: n = 11, control: n = 11 Mean age: experimental: 66 years, control 72 years Sex (male/female): experimental: 6/5, control: 6/5 Time post‐onset (mean days): experimental: 35, control: 30 Exclusions: history of stroke, alteration of general status, or cognitive difficulties incompatible with rehabilitation | |
| Interventions | 1 hour per day for 20 days of experimental treatment followed by traditional rehabilitation (1 to 2 hours physiotherapy and 1 hour OT; experimental treatment is Bon Saint Come method: participant wears a thoracolumbar vest with attached metal pointer above head, participant points to target on mobile wooden panel, audible and luminous signals provide biofeedback effect when targets are touched; initially conducted when sitting, this progresses to standing, the therapist participates actively during the session, stimulating, guiding and correcting) versus 3 to 4 hours traditional rehabilitation per day For analysis of bottom‐up and top‐down rehabilitation approaches this review coded the experimental condition as top‐down | |
| Outcomes | The study collected 2 types of outcomes:
These assessments were conducted 3 times: day 0, day 30 (after therapy) and day 60 This review used only the data from line bisection and FIM. Both the 30 day (immediate) and 60 day (persisting) data were used in this review |
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| Notes | The paper consists of 2 studies. These data refer to Study 1 only The experimental group were younger and had a higher initial FIM score (66) than the control group (54) Cancellation data reported as errors rather than correct performance. Only 1 set of cancellation data (lines not bells) were entered in this review to avoid entering the same group of participants twice into the meta‐analysis Line bisection scores are % deviation to right Control group had more, but not significantly so, omissions on line cancellation (control 16, experimental 14) and right deviations on line bisection (control 53%, experimental 50%) at baseline compared with experimental group | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | High risk | Information on allocation concealment unclear. Random number tables |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated. Assessment done by 'one of us (LW)'. Different from person delivering therapy |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No incomplete data |
| Free of systematic differences in baseline characteristics of groups compared? | High risk | Control group older and more disabled |
| Did authors adjust for baseline differences in their analyses? | High risk | No correction made |