Fong 2007.
Study characteristics | ||
Methods | 3‐arm RCT Setting: rehabilitation hospital, Hong Kong | |
Participants | 60 participants Experimental 1: n = 20; experimental 2: n = 20; control: n = 20 Number lost to follow‐up: immediate post treatment (Day 30) assessments on 19, 20, and 15, respectively Also lost 5, 0, and 3, respectively to follow‐up (Day 60), so final analysis of 14, 20, and 12 Adequacy of matching at baseline? yes: P values are reported for all demographics and for baseline data ‐ there are no significant differences Mean age, mean (SD): experimental 1 = 69.9 (11.0), experimental 2 = 69.9 (9.8), control = 73.8 (9.9) Sex (men/women): 34/20 Side of damage: all had right brain damage Time post onset, days (SD): experimental 1 = 12.1 (9.4), experimental 2 = 11.6 (5.1), control = 12.1 (7.1) Inclusion criteria: first or second unilateral right lesion stroke confirmed by imaging and examination, admitted to rehabilitation hospital, < 8 weeks since stroke onset, right‐handedness, left visual inattention or neglect diagnosed by < 51/54 on Star Cancelled of BIT and GCS = 15 at recruitment Exclusion criteria: severe aphasia, significantly impaired visual acuity, hemianopia Visual sensory deficit: hemianopia and visual acuity assessed (method of assessment not stated) | |
Interventions | Experimental 1: voluntary trunk rotation
1 hour per day, 5 days per week for 30 days = 30 hours; OT present throughout
Each hour composed of 15 minutes ADL + 45 voluntary trunk rotations with setup equipment (supine, unsupported sitting, and standing frame) reaching with ipsilateral hand into contralateral space and therefore rotating upper body/trunk by 15 to 35 degrees from midline. Used setup apparatus (pegboard or shoulder arc). Voluntary or if necessary therapist‐provided verbal or motor prompting for 15 minutes Experimental 2: voluntary trunk rotation and half‐field eye‐patching Same amount and content as experimental group 1 but wearing half‐field eye‐patches to ipsilesional (right) hemi‐field wearing patches on plastic goggles (over own glasses if necessary) Control: same amount of time as experimental groups 1 and 2. Conventional OT for hemiplegia (15 minutes ADL + 45 minutes training upper extremity). No mention of any neglect‐specific treatment, implying treated as if had only hemiplegia For analysis, voluntary trunk rotation with half‐field eye‐patching was classed as the experimental condition, and control as the control condition Profession of outcome provider: OT |
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Outcomes | Used 3 (some with multiple subtests) at 2 follow‐up time points (Day 30 immediately post therapy + Day 60)
Did not measure serious adverse events; excluded anyone re‐hospitalised or with deteriorating health |
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Notes | "Recruitment hypothesis" target both spatial representation and motor intentional deficits of personal and peri‐personal space ‐ this is the voluntary rotation plus eye‐patches "Inexpensive and easily integrated into use in day‐to‐day rehabilitation" Lack of intention‐to‐treat analysis, no baseline data for those allocated, baseline data for those followed up suggests pre‐therapy differences described in 'Risk of bias' table below | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Patients were "allocated to different groups according to their orders of admission to the study" |
Allocation concealment (selection bias) | High risk | Personal communication with study authors: "we didn't have concealment of allocation of participants from the person who was recruiting" |
Blinding of participants | High risk | Not mentioned and not practicable |
Blinding of personnel | High risk | "The investigators were not blinded to group membership, and were also responsible for the intervention as allocated by the data manager” |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Two independent blinded assessors, who were blinded to group membership, were responsible for all repeated measures throughout the duration of the study" |
Incomplete outcome data (attrition bias) All outcomes | High risk | Although reasons for post‐randomisation exclusions are stated, it would have been preferable if all participants had been included in intention‐to‐treat analysis |
Selective reporting (reporting bias) | Unclear risk | Unclear |
Other bias | Low risk | P values reported for all demographic and baseline data ‐ no significant differences |