Chan 2006.
Study characteristics | ||
Methods | Study design: matched‐pair RCT Method of randomisation: "Random assignment of patients into the sequential function‐based motor relearning group and the conventional therapy (control) group was conducted in two stages. The first stage involved arranging patients into a block of six participants and then forming the six into pairs by matching their age and gender; then, if possible, they were matched according to the level of intensity of physiotherapy and speech therapy received in the hospital. Patients who did not form a best‐matched pair were automatically entered into the next block for further matching and randomization. The patients were excluded from the study if their characteristics were not matched by the end of the second round. The second stage involved randomly assigning the two patients in each of the best‐matched pairs to either the motor relearning or the control groups by drawing one of two sealed envelopes designating the group membership" |
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Participants | Number of participants: n = 66 Inclusion criteria: "patients had to be between 21 and 65 years of age (eligible admission to outpatient setting), diagnosed as having suffered a first stroke, the stroke must have occurred within the previous 12 months, and patients had to be able to follow simple instructions as screened by the Chinese version of the Cognistat" Exclusion criteria: "conditions were complicated by other musculoskeletal injuries and/or visual deficits" |
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Interventions | (1) Motor relearning group (n = 33) "Both programmes were conducted in the same treatment area located in the occupational therapy department of the hospital. The patients in both programmes also received physical therapy in the form of lower limb strengthening and trunk balance exercises. The patients attended physical therapy from one to three times a week. Their attendance was monitored throughout the study, and the number of sessions was incorporated into the analysis of the results" "In the motor relearning programme, the intervention technique followed four sequential steps: identification of the missing performance components (step 1), training using remedial exercises (step 2), training using functional task components (step 3), and transfer of skills to functional task performance (step 4). A total of 24 remedial tasks (used in step 2) and 10 functional tasks (used in step 4) were designed to cover deficits in static and dynamic sitting balance, and static and dynamic standing balance. Throughout the training session, the therapist stressed the importance of relating the training processes taking place in steps 2 and 3 to practices in step 4. The training progressed by advancing from a sitting to a standing position, and from static to dynamic balancing. The criteria established for progression were clearly defined, and those patients who demonstrated the desirable skills were upgraded to another stage of training" The individual components delivered are listed in Table 6. Based on the individual components, this intervention is categorised as functional task training Length of intervention period: six weeks Number of sessions and length of individual sessions: three two‐hour sessions each week (18 sessions total) Intervention provider: occupational therapist: "The researcher conducted the motor relearning programme" (2) Conventional therapy group (n = 33) "The skill training method was adopted for use with patients receiving the conventional therapy programme. The same number of remedial and functional tasks was covered as in the motor relearning programme. The selection of remedial tasks followed the principle of progressing from a sitting to a standing position, and from static to dynamic balance. The training of functional tasks began with simple self‐care and bedside tasks, such as bed mobility, and progressed to more complicated tasks, such as use of community facilities. Unlike the motor relearning programme, the patients were not involved in identifying their own missing performance components (Table 5). The relationships between the practices of the remedial tasks and the entire functional task performance were not reinforced" The individual components delivered are listed in Table 6. Based on the individual components, this intervention is categorised as functional task training Length of intervention period: six weeks Number of sessions and length of individual sessions: three two‐hour sessions each week (18 sessions total) Intervention provider: "another occupational therapist conducted the conventional therapy programme. The therapist responsible for the conventional therapy programme was trained in the standardized procedure for conducting the control programme" This study is classified as active intervention one (functional task training) versus active intervention two (functional task training) (Table 9) |
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Outcomes | Measures of independence in ADL: Functional Independence Measure Measures of postural control and balance: Berg Balance Scale, Timed Up and Go test Measures of participation: instrumental ADL Measures of quality of life and social isolation: Community Integration Questionnaire Time points when outcomes were assessed: "The assessment schedule was laid out at baseline (after randomization), two weeks, four weeks, and six weeks" |
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Notes | The two active interventions appear fairly similar. As the two active treatment groups were classified as including similar treatment components, data from this study have not been included within the comparisons of one active intervention versus another active intervention | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | "Random assignment of patients into the sequential function‐based motor relearning group and the conventional therapy (control) group was conducted in two stages. The first stage involved arranging patients into a block of six participants and then forming the six into pairs by matching their age and gender; then, if possible, they were matched according to the level of intensity of physiotherapy and speech therapy received in the hospital. Patients who did not form a best‐matched pair were automatically entered into the next block for further matching and randomization. The patients were excluded from the study if their characteristics were not matched by the end of the second round. The second stage involved randomly assigning the two patients in each of the best‐matched pairs to either the motor relearning or the control groups by drawing one of two sealed envelopes designating the group membership" Judged as high risk, as if participants were not matched, then they could be excluded—thus participants did not all have an equal chance of being entered into the trial. The study authors state: "The best matched process used in the randomization might introduce biases into the selection of patients to participate in the study" |
Allocation concealment (selection bias) | Low risk | "The randomization process was carried out by a registration clerk who was not involved in any part of the study" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "All the clinical outcome assessments were conducted by two occupational therapists who were working in the orthopaedic unit of the same outpatient centre. The assessors were blind to the group membership of the patients they assessed. Training sessions were provided to all raters on administering and scoring each clinical instrument in order to minimize any biases associated with the assessment process" |
Incomplete outcome data (attrition bias) All outcomes | High risk | In the motor relearning group, seven participants discontinued the intervention for the following reasons: "suspended treatment due to travelling for more than two weeks (n = 2); re‐admitted to hospital due to medical problem (n = 1); excluded from analysis due to the drop‐out of matched counterpart in conventional therapy group (n = 4)" In the conventional therapy group, seven participants discontinued the intervention for the following reasons: "suspended due to irregular attendance (n = 1); re‐admitted to hospital due to medical problem (n = 1); defaulted treatment (n = 2); excluded from analysis due [to] drop‐out of matched counterpart in motor relearning group (n = 3)" Judged at high risk as the result of exclusion of participants because their "matched counterpart" dropped out |
Free of systematic differences in baseline characteristics of groups compared? | Low risk | "There were no significant differences in the demographic and medical characteristics of the patients between the motor relearning and control groups. Also, no significant differences were found in their scores on the five outcome measures at the baseline" |
Did authors adjust for baseline differences in their analyses? | Low risk | No information provided |
Other bias | High risk | Judged at high risk, as study authors state: "Although the assessors were blind to the study, the motor relearning programme was conducted by the researcher, who might have provided more enthusiastic interventions than the therapist who conducted the control programme" Additionally, "The patients received other treatment interventions in addition to the motor relearning or control programme, such as physiotherapy and speech therapy, that could contaminate the treatment effects. The patients attended the treatment sessions as day‐patients, and their engagement in activities other than those conducted during treatment possibly further contaminated these effects" |