| Study characteristics |
| Methods |
RCT
Setting: hospital, Germany |
| Participants |
23 patients with left spatial neglect after acute (< 14 days) right hemisphere stroke
Experimental = 11, control = 10
Diagnosis of neglect: neglect if patients showed pathological performance on ≥ 2 tests of a neuropsychological test battery consisting of the following paper–pencil tests: line bisection, star cancellation, text reading, Bells cancellation, and Ogden figure copying task
Age, years, mean (SD): experimental = 69 (3), control = 39 (3)
Sex (men/women): experimental = 8/3, control = 6/4
Days between stroke and treatment, mean (SD): experimental = 3 (1), control = 5 (1)
ADL before treatment CBS, mean (SD): experimental = 17 (3), control = 18 (3)
Exclusion: previous stroke, neurodegenerative disease, inability to give informed consent |
| Interventions |
Patients in the treatment group received HEPOKS in addition to usual stroke care (physio, speech, and occupational therapy), whereas patients in the control group had usual care only. HEP was applied by spectacle frames containing non‐corrective lenses for which the right half was patched with dark non‐translucent tape. Participants were instructed to wear the glasses all day for 7 days and to remove them only for the OKS treatment sessions. Investigators, care providers, and patients’ relatives regularly checked on correct use of the glasses. Daily OKS sessions (15 minutes each) were applied at the bedside. Seventy coloured geometric objects were coherently moving on an 18.4″ notebook monitor from right to left at varying speeds (8° to 12°/s) |
| Outcomes |
2 primary outcome measures: (1) mean performance (accuracy) on neuropsychological test battery, (2) neglect‐related functional disability measured by Catherine Bergego Scale
Secondary outcome measures were Barthel Index, modified Rankin scale, National Institutes of Health Stroke Scale
Participants were assessed at 3 time points (Figure 1): baseline (Day 1), post treatment (Day 8), and follow‐up (Day 30) |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
The principal investigator sent a fax including identification parameters of the eligible patient (no name and initials) to the IMBS. A staff member at the IMBS with no clinical involvement in the trial randomised the patient online using a computerised permuted block technique with varying block size and assigned the unique patient identification number (PID). The randomisation result and the PID were documented on the fax and sent back to the investigator |
| Allocation concealment (selection bias) |
Low risk |
See above |
| Blinding of participants |
High risk |
Due to the nature of a cognitive intervention trial, both investigators and patients were aware (not “blind”) of the allocated arm throughout the study |
| Blinding of personnel |
High risk |
See above |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Unclear if blinded |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Unclear |
| Selective reporting (reporting bias) |
Low risk |
Secondary outcomes are in data supplement |
| Other bias |
Unclear risk |
At baseline, study groups did not differ significantly in demographic, clinical, and neuropsychological characteristics, except for 1 paper–pencil subtest (Table). Lesion overlap analyses are provided in Figure II in the online‐only Data Supplement |
