Oostra 2015.
Study characteristics | ||
Methods | RCT | |
Participants | All patients sustained stroke between August 2009 and June 2013. Patients were recruited via the University Hospital and from hospitals in East and West Flanders to the Rehabilitation Centre, University Hospital of Ghent MI training: 21, muscle relaxation: 23 Sample size: 44 Inclusion criteria: 1) had experienced a first‐ever stroke less than 1 year before entering the study; 2) able to walk 10 meters with minimal assistance (Functional Ambulation Category ≥ 3); 3) able to pass the Time Dependent Motor Imagery screening test; 4) between 16 and 70 years old; and 5) did not have psychiatric symptoms or any other neurological disease Exclusion criteria: not reported by study authors Mean (SD) age: MI training group: 50.3 (SD 12.8) years; muscle relaxation group: 53.7 (SD 12.0) years Stroke details: MI training group: 13 ischaemic/8 hemorrhagic; muscle relaxation group: 15 ischemic/8 hemorrhagic Stroke phase: subacute |
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Interventions | Experimental group: MI training: practice was performed from an internal perspective with both a visual (“viewing” themselves performing the task) and kinesthetic mode (“feeling” the experience of performing the task), with emphasis on the latter Control group: muscle relaxation: this group, on the other hand, received the same amount of muscle relaxation therapy over and above the standard rehabilitation training All patients in both groups received a standard rehabilitation program, consisting of 2 hours physical therapy and 1 hour occupational therapy daily, 5 days per week |
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Outcomes | Outcomes recorded at baseline and after 6 weeks of intervention Walking speed: 10 Meter Walk Test. Motor function: Lower‐extremity Fugl‐Meyer Assessment Scale |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: “a process of blinded random number allocation” |
Allocation concealment (selection bias) | High risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | High risk | All the participants had to be aware of the therapies to participate in the study, since it involved physical and cognitive exercise |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: “the physician responsible for assessment of patients throughout the study remained blinded to the patients’ group allocation for the full duration of the trial" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: “None of the participants dropped out during the study" |
Selective reporting (reporting bias) | Low risk | Quote: “The 10‐m walk scores and lower extremity Fugl‐Meyer assessment (LE‐FMA) scores improved significantly in both groups after treatment (P < 0.001 for both values). We also found a significant group interaction effect for the 10‐m walk test (F(1,43) = 4.5, P < 0.05), revealing a significantly reduced walking duration in the MIT group compared with the MR group. There was no significant interaction between session and group for the LE‐FMA score". |
Other bias | Low risk | None detected |