Jiang 2016.
Study characteristics | ||
Methods |
Design: 2 × 2 factorial design RCT (note: data only for 2 groups included in this review: CG and RehaCom computer training alone group). Duration of trial: 28 months (August 2013 to November 2015) Unit of randomisation: people within 6 months poststroke with cognitive dysfunction; aged 18–75 years Recruitment and allocation: of 1020 recruited people with stroke being treated (as inpatients or outpatients, Yang 2014), 240 people were eligible and randomised to 4 groups: conventional therapy (CG) (n = 60), acupuncture group (n = 60), RehaCom treatment group (IG) (n = 60), and acupuncture plus RehaCom group (n = 60). |
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Participants |
Setting: 1 university traditional Chinese medicine hospital Country: China Sample size: 120 adults allocated, 100 analysed, 49% men; IG: 51; CG: 49 Inclusion criteria: clinical diagnosis of first stroke incident within the preceding 6 months; aged 18–75 years; MMSE score within specific range according to education level; conscious and in stable physical condition Exclusion criteria: existing mental disorder before stroke onset; severe hearing or vision problems affecting computer‐based assessment and training; pregnancy or breastfeeding; bleeding disease; heart, liver, or kidney failure or other serious disease; prior participation in other clinical trials Age: mean: IG: 62.37 (SD 7.89) years; CG: 60.53 (SD 9.19) years Time since onset of stroke: mean: IG: 44.22 (17.00) days; CG: 42.76 (SD 16.00) days Types of stroke: most participants had ischaemic strokes (IG: 61%; CG: 63%) Site of lesion: left (IG: 53%; CG: 51%) |
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Interventions |
Intervention group Brief name: RehaCom Recipients: adults within 6 months poststroke with cognitive dysfunction Why: to provide computer‐based training with 5 different treatment programmes designed to "restore attention, memory, and executive function and to improve the visual field". What (materials): RehaCom software (Chinese version). See hasomed.de/en/products/rehacom/ for more details. The software is available in 27 languages at no extra cost; computer. What (procedures): conventional therapy plus computer software training with RehaCom, which includes 5 different therapeutic programmes, each with 1–4 different tasks from which participants chose during each therapy session and 3–5 varying levels of difficulty. The provider chose the program and difficulty level according to each participant's needs and provided guidance or reminders and increased difficulty according to patient feedback. Who provided: physiotherapists using commercially available software. The RehaCom website states that the software is used "extensively by … occupational therapists" and other clinicians in rehabilitation centres, hospitals and clinics. The protocol (Yang 2014) stated the following requirements of training and experience:
How: face‐to‐face and appeared to have been individually Where: not specified but within rehabilitation hospital When and how much: 30 minutes per day, 5 days per week, total of 60 sessions over 3 months (30 hours in total) Tailoring: the physiotherapists chose different training programmes and difficulty levels according to the specific circumstances of each participant and increased the training difficulty according to patient feedback. Modifications: none reported in paper, but protocol stated that the investigators could be convened to discuss practical issues such as intervention protocol revisions (Yang 2014). How well (planned): not reported How well (actual): not reported Comparator group Brief name: conventional therapy Recipients: adults with stroke with cognitive dysfunction Why: to provide rehabilitation services to people poststroke What: traditional rehabilitation therapy, including basic treatment according to Chinese guidelines for cerebrovascular disease, healthy lifestyle education, occupational therapy and physical therapy, medical exercise therapy, hydrotherapy, except CT (Yang 2014) Who provided: medical staff and rehabilitation professionals, such as occupational therapists and physiotherapists How: face‐to‐face Where: rehabilitation hospital When and how much: 12 weeks Tailoring: doctors administered appropriate treatment according to patients' needs. Modifications: not reported How well (planned): not reported How well (actual): not reported |
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Outcomes |
Primary
Secondary
Methods of data collection: demographic data were obtained on enrolment. Researchers stated that they "tried to ensure that the same therapist completed each patient’s cognitive assessment and that he/she did not participate in patient treatment"; protocol stated that outcome assessors would not be involved in screening and allocating of participants (Yang 2014). Data collection time points: baseline and 12 weeks (post‐treatment) |
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Notes |
Funding: yes Conflict of interest: none Published trial protocol: yes; Yang 2014 Trial registration: yes (Chinese Clinical Trial Registry: ChiCTR‐TRC‐13003704) Ethics approval: yes |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Paper referred to study protocol for details of design, which stated that the random allocation sequence would be generated by an independent statistician using statistical software. |
Allocation concealment (selection bias) | Low risk | Paper referred to study protocol for details of design which described detailed management of blinded allocation by an independent research assistant. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Reported that the researchers "… tried to ensure that the same therapist completed each patient's cognitive assessment and that he/she did not participate in patient treatment …"; reported in protocol as "not possible". |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Reported in paper that researchers "tried to ensure that the same therapist completed each patient's cognitive assessment and that he/she did not participate in patient treatment …"; protocol stated, "Although patients, investigators, and therapists administering treatment will not be blinded, those assessing the patients for primary and secondary endpoints will be blinded to patient treatment assignment. The investigators, therapists and assessors are different people. Patients will be told not to talk to the examiner about the group allocation or therapy content during the post‐intervention assessments" (Yang 2014). |
Incomplete outcome data (attrition bias) All outcomes | High risk | Analysis per‐protocol rather than intention‐to‐treat and 15% missing in IG and 18% in CG. |
Selective reporting (reporting bias) | Low risk | All outcomes planned in protocol were reported. |
Other bias | Low risk | No other identifiable bias. |