Caution is warranted in interpreting data from a recent trial of modified constraint‐induced therapy

SIR–We have several concerns about the recent article1 by Wallen et al. The novel modified constraint-induced therapy (mCIT) was carried out ‘… predominantly by parents, at times and locations that suited family responsibilities and routines.’ The intervention was based on motor learning principles, but the only parent training described was giving them ‘… guidelines (written and verbal) for carrying out the allocated intervention.’ The protocol required the child to wear a mitt 2h per day while parents gave adjunct therapy for 8 weeks. Intervention fidelity was not reported, nor is it clear that critical features of CIMT2 were followed. The mCIT children had weekly occupational therapy scheduled, but its protocol was not specified and fidelity not monitored. At least one child received only four of eight sessions. Levels of mitt use and daily dosage (mean=1.3h per day) were only 67% (presumably based on parent report) of intended treatment. Intensive occupational therapy (conducted by >20 therapists) was characterized as ‘… goal-directed, intensive, supervised, and involved a formal home programme.’ This intensive therapy resulted in a mean of 0.8h per day (presumably including parent-administered home activities) and a weekly occupational therapy session. Therapist training and intervention fidelity were unreported. We commend the authors for reporting post-treatment engagement, but are perplexed that the intensive occupational group received a mean of 4.0h per week compared to 1.5h per week for the mCIT group. This appears to contradict the statement ‘After intervention, families were instructed to resume their usual therapy … until completion of the 6-month assessment’. This large post-treatment difference should have been addressed in analyzing and interpreting 6-month outcomes. The Canadian Occupational Performance Measure was designated the primary outcome, although deemed valid and appropriate only after age 8 (children’s mean age was 48.6 months).3 Selecting a primary outcome based on parent ratings of attaining self-identified treatment goals is problematic, particularly because parents were the primary providers of mCIT and collaborators in the intensive occupational therapy condition. Wallen et al.1 showed parents their baseline and post-treatment ratings when parents completed 6-month ratings – a non-standard practice insufficiently justified by the rationale ‘… to guard against alteration of parental expectation of the child.’ These parents were, of course, unusually highly invested in treatment delivery and seeing the child progress. For data analyses, findings focused on whether the two interventions produced different results. They failed to report whether the groups showed statistically significant treatment benefits. From Table III data, we conducted t-tests that indicate none of the seven reported objective outcome scores, based on what the authors described as ‘mostly blinded’ assessments, produced significant effects. The Assisting Hand Assessment (AHA), one of the most reliable and valid measures for this population, showed small gains (using scaled scores, rather than recommended logit scores4) that were not significant for either group from pre- to post-treatment (t-test=0.28, p=0.78/NS for mCIT; t=0.26, p=0.80 for intensive occupational therapy) or pre-treatment to 6-month follow-up (t=0.92, p=0.36/NS for mCIT; t=0.57, p=0.57). Because the authors conclude their study was limited by lack of a group that received traditional CIMT to compare outcomes, we provide such data in Figure 1 of our letter. The comparison data come from our recent randomized control trials comparing two CIMT dosage levels: 3h a day versus 6h a day for 21 days, using full-arm constraint for 3.5 weeks.5 We re-scored the AHA and Pediatric Motor Activity Log (PMAL) to match Wallen et al.’s methods. Figure 1 shows that the two Wallen et al. interventions produced markedly smaller gains than did traditional CIMT (note: the 3 and 6h per day CIMT dosages yielded comparable and significant improvements5). The objective AHA outcomes showed a mean increase of 2.8 for the combined Wallen et al. groups, compared to a mean of 13.2 for the traditional CIMT groups. For the parent-rated PMAL, widely used in CIMT trials, children in the two traditional CIMT groups had improvements more than twice as large as those in the mCIT and intensive occupational therapy groups. Assisting Hand Assessment (AHA) and Pediatric Motor Activity Log (PMAL) scores as a function of intervention (type and dosage). (a) AHA scaled scores (blinded assessment). (b) PMAL (parent ratings): (1) Frequency of use (% of total possible); (2) Quality of movement (% of total possible). An asterisk (*) indicates t-test comparing the post-intervention score to baseline was significant at p < 0.01. CMIT, constraint-induced therapy; m, modified; ped, pediatric; Pre, pre-treatment; Post, post-treatment; 6mo, 6 months post-treatment. Our most serious concern is how Wallen et al. interpreted the results in their abstract and conclusion. The abstract’s sole interpretation was that ‘Modified constraint-induced therapy is no more effective than intensive occupational therapy for improving completion of activities of daily living or upper limb function in children with hemiplegic CP.’ This represents an egregious omission of the finding of no significant objective benefits in either treatment group. Further, improvements based on parent PMAL ratings were far smaller than those in other CIMT studies. The authors’ ending statement that ‘… inclusion of constraint is not the primary determinant of effect in programmes of mCIT’ has no supporting data whatsoever from this trial.

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