Varalta 2019.
Study characteristics | ||
Methods | Single‐center, pilot RCT Setting: Italy | |
Participants | Inclusion criteria: age > 18 years; presence of ischaemic or haemorrhagic stroke (as documented by computerised tomography or magnetic resonance imaging scan) that had occurred at least 6 months earlier; presence of hemi‐spatial neglect (Star Cancellation Test score < 50); ability to actively rotate the head toward the left in a closed‐eyes condition (absence of musculoskeletal disorders) Exclusion criteria: participation in other trials; dementia (Mini Mental State Examination correct score < 23.80); presence of severe comprehension deficits, psychiatric disorders, deficits of somatic sensation involving the cervical dermatome map (C3–C5), or visual field deficits as assessed by neurological examination; other neurological or orthopaedic conditions involving the neck and visual ability Age, years, mean (SD): intervention = 65.5 (10.2), control = 67.0 (11.5) Sex (men/women): intervention = 2/5, control = 4/1 Hemisphere damaged: not reported Time since stroke, mean months (SD): intervention = 19.7 (27.7), control = 28.0 (40.6) |
|
Interventions | Neck taping or sham neck taping. For the intervention group, tape was placed according to Kenzo Kase's Kinesio Taping Method by an experienced physiotherapist. The tape strip was applied from the mastoid bone to the clavicle (rostrocaudal direction) with the sternocleidomastoid kept in a position of maximum stretching. Two I‐strips were applied: the first placed on the medial (sternal) head, and the second on the lateral (clavicular) head, of the sternocleidomastoid muscle, with 15% to 25% tension (paper‐off tension) For the control group, smaller I‐strips were used. To eliminate the specific therapeutic elements of elastic taping (i.e. longitudinal stretch, start and ending points of tape application), the strips were applied. All patients wore the tape for 30 days |
|
Outcomes |
All taken immediately post intervention with no longer‐term follow‐up |
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Balanced (restricted) randomisation scheme”; only detail |
Allocation concealment (selection bias) | Low risk | We used an allocation concealment mechanism (sequentially sealed numbered containers). Another investigator checked for correct patient allocation according to the randomisation list. After unmasking at the end of the study, we checked that no allocation errors had been made |
Blinding of participants | Unclear risk | All participants were taped by the same investigator, who was not involved in the outcome assessment |
Blinding of personnel | Unclear risk | Unclear |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | All patients were evaluated by the same investigator, who was blinded to group allocation. The success of blinding was tested by asking the assessor to make an educated guess |
Incomplete outcome data (attrition bias) All outcomes | Low risk | None |
Selective reporting (reporting bias) | Low risk | Outcomes reported with equal detail |
Other bias | Low risk | Nothing obvious |