Modden 2012.
Study characteristics | ||
Methods |
Restitutive intervention versus compensative intervention Design: prospective randomised controlled, single‐blind, single‐center treatment study Stratification: no Randomisation sequence: "Patients were randomly assigned to receive either CT, RT, or OT. Randomization by throwing dice and allocation took place before starting with the initial assessment of neuropsychological tests". Comparisons: compensatory therapy (CT) versus restorative computerised training (RT) versus standard occupational therapy (OT) Allocation concealment: no Blinding: no ("All patients were recruited and assigned to treatment groups by a neuropsychologist. The same neuropsychologist also tested the patients before (time point T1) and after (time point T2) the treatment and was not blinded to the type of training. The training itself was performed by a psychological assistant or by the occupational therapists not involved in the study, and they provided the test results at T1 and T2." Power calculation: yes Intention‐to‐treat analysis: no dropouts Patient and public involvement: not stated |
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Participants |
Total study population: 45 patients randomised Withdrawals: 0 Method of diagnosing VFD: "a perimetry test from the Test Battery of Attentional Performance, the latter having a sensitivity and specificity for visual field defects similar to the Goldmann perimetry." Characteristics of population: participant details are listed in Table 6. Type and severity of visual problems: participant details are listed in Table 7. Inclusion criteria: homonymous hemianopia with a posterior cerebral artery stroke Exclusion criteria: visual neglect, eye‐movement disorders, neuropsychological disorders like aphasia, dysexecutive syndromes, memory deficits, or higher order motor impairments like apraxia Baseline comparison of treatment groups: "At baseline, the 3 groups did not differ in demographic and neuropsychological measures". |
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Interventions |
Group 1: restitution therapy (RT) (n = 15) Intervention: RT ‐ computer‐based stimulation of visual field Intervention type: restitutive. Materials: computer‐based restitution therapy: "A therapy‐integrated perimeter program (provided by Teltra company)". Procedures: "A therapy‐integrated perimeter program (provided by Teltra company) created the exact measurement of the individual visual field border. Using that measurement, a series of colored targets appeared on a blue screen anywhere at 1 of 10 positions on the border line. A randomly presented first fixation target (a rotating arrow) announced the second stimulus target in the hemianopic border zone (basic principle of covert attention shift). The patients were instructed to respond (by pressing a key) to each stimulus target (colored and flickering frames, beams, and spots) as soon it was perceived. The program contained no adaptive difficulty levels. Eye movements were not allowed, and this was controlled by the assistant". Provided by: "The training itself was performed by a psychological assistant or by the occupational therapists not involved in the study". Delivery: face‐to‐face, individual, location rehabilitation centre: "The participants in both PC‐based therapy groups were seated 60 cm away from the screen (19‐inch monitor) and had to perform the tasks binocularly. As during testing, the head was fixed by a chin rest, the sessions were always controlled by the assistant to make sure that the instructions were followed." (Table 5). Regimen: 30 minutes/day for 15 sessions. Tailoring: no: "The program contained no adaptive difficulty levels." Modification: no. Adherence: stated "no‐one dropped out because of problems with compliance". Group 2: compensatory therapy (CT) (n = 15) Intervention: CT ‐ computer‐based stimulation of visual field Intervention type: compensatory. Materials: computer‐based: "The 'Exploration' task (from RehaCom, provided by HASOMED GmbH, Magdeburg, Germany)". Procedures: "The “Exploration” task. . . . . . . . . . . was adapted individually according to the side of the hemianopia. On a dark background, different bright stimuli arranged in rows and columns were presented. A ring (diameter of 2 cm) moved line by line (interlaced) on a matrix unit over the field. The participant was instructed to follow the ring (starting point to an outmost fixation in the blind side) by eye movements and to identify a critical targeted icon. The targets were not always distributed homogeneously but were clustered in the blind side. Thus, the exploration in the hemianopic field was further promoted. The patients had to respond (by pressing a key) when the targeted icon was perceived in the circle. Provided by: "The training itself was performed by a psychological assistant or by the occupational therapists not involved in the study". Delivery: face‐to‐face, individual, location rehabilitation centre: "The participants in both PC‐based therapy groups were seated 60 cm away from the screen (19‐inch monitor) and had to perform the tasks binocularly. As during testing, the head was fixed by a chin rest. The sessions were always controlled by the assistant to make sure that the instructions were followed." (Table 5). Regimen: 30 minutes/day for 15 sessions. Tailoring: yes: "The program contained several difficulty levels. In levels 1 to 20, all lines were completely filled with symbols, whereas there were omissions in the rows of symbols in levels 21 to 30 to increase the difficulty." Modification: not clear. Adherence: stated "no‐one dropped out because of problems with compliance". Group 3. occupation therapy (OT) (n = 15) Intervention: OT ‐ standard occupational therapy Intervention type: compensatory. Procedures: "After a standardized assessment of daily living activities, the therapy consisted of individually adapted stimulation of daily activity tasks to compensate via eye‐, head‐, and body movements. These compensation strategies included aspects of spatial and body perception, searching or arranging objects, pen and paper searching task, reading maps or newspapers, and self‐care activities. The participant was instructed to perform systematic eye movements toward the lost visual field. The interventions were carried out in the treatment rooms, on the wards, in a kitchen or a bathroom, outside in the park, or in a supermarket." Provided by: occupational therapist. Delivery: face‐to‐face, individual, location rehabilitation centre: (Table 5). Regimen: 30 minutes/day for 15 sessions. Tailoring: yes: "After a standardized assessment of daily living activities, the therapy consisted of individually adapted stimulation of daily activity tasks". Modification: not clear. Adherence: stated "no‐one dropped out because of problems with compliance". Note: "Patients receiving RT and CT did not receive OT in the context of their standard rehabilitation treatment." |
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Outcomes | See Table 8 Visual field expansion ‐ test battery of attentional performance visual field assessment Visual search performance ‐ cancellation Reading performance ‐ Weschler memory tests ADL ‐ Extended Barthel Index Time points when outcomes were assessed: after completion of training |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | High risk | Randomisation was by throwing a dice: no allocation concealment. |
Blinding (performance bias and detection bias) All outcomes | High risk | No blinding: "All patients were recruited and assigned to treatment groups by a neuropsychologist. The same neuropsychologist also tested the patients before (time point t1) and after (time point t2) the treatment and was not blinded to the type of training. The training itself was performed by a psychological assistant or by the occupational therapists not involved in the study, and they provided the test results at t1 and t2." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts |
Other bias | Low risk | No other concerns noted |