QUINTO RELATO

3.4.2.1 Does CIMT increase UL function in sub-acute stroke survivors (14 days to nine months post-stroke)?

There is good quality evidence (Wang et al., 2011; Wolf et al., 2006) that CIMT leads to significantly improved UL activity and participation (WFMT and MAL) outcomes, and evidence from a poor quality study that it increases body function (grip strength) UL outcomes (Alberts et al., 2004) compared to customary care, of unequal duration. Three small studies suggest that CIMT leads to better activity and participation (FMA-66UL component, WMFT and MAL)

outcomes than no intervention (Atteya, 2004; Page et al., 2002b; Page et al., 2001), although all three studies were found to be at high risk of bias.

Where studies compared CIMT to an equal duration intervention, the results were more varied. Three studies (Brunner et al., 2012; van Delden et al., 2013; Wang et al., 2011) found no

difference in activity and participation UL outcomes (ARAT, 9HPT, MAL, WMFT) between CIMT and interventions (bilateral interventions and conventional rehabilitation) of comparable duration. In contrast, Myint et al. (2008) found CIMT led to significantly improved activity and participation UL outcomes on the majority of measures used (grip component of ARAT, NHPT and MAL), compared to an equal duration intervention (conventional therapy). Although all four studies (Brunner et al., 2012; Myint et al., 2008; van Delden et al., 2013; Wang et al., 2011) were of moderate quality, it is not possible to analyse this discrepancy further as the CIMT protocols in the four studies were all different, as were the comparison interventions and the outcomes measured. This heterogeneity may explain the differences in the outcomes of these studies.

There is evidence from four studies (Brogårdh et al., 2009; Hammer & Lindmark, 2009a; Krawczyk et al., 2012; Treger et al., 2012) that there is no significant difference in body function and activity

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UL outcomes (good evidence) or participation UL outcomes (moderate evidence) for a CIMT group with constraint compared with a group undertaking the same training without the constraint element. In all four studies both groups had significantly improved UL outcomes post- intervention. Again there was substantial variation in the protocols and assessments (Tables 3.2 and 3.3).

There is evidence that CIMT increases UL function in sub-acute stroke survivors (14 days to nine months post-stroke), but there is significant heterogeneity in the CIMT protocols and comparison interventions in the studies, on which this conclusion is based.

3.4.2.2 Adverse events and reactions

Eight of the original studies did not report adverse events or reactions (Atteya, 2004; Brogårdh et al., 2009; Brunner et al., 2012; Hammer & Lindmark, 2009a; Page et al., 2002b; Page et al., 2001; Treger et al., 2012; van Delden et al., 2013). Three studies (Krawczyk et al., 2012; Singh & Pradhan, 2013; Wang et al., 2011) stated there were no adverse events. Myint et al. (2008) reported one exacerbation of a pre-existing shoulder pain, whilst Wolf et al. (2006) reported a total of 14 events in the control group and 21 events in the customary care group that required hospitalization within 12 months of enrolment. Only one event (a stroke) occurred during the intervention period, there was no significant difference between the groups in rate of adverse effect. A further study (Underwood et al., 2006) studied a sub-set (n=18) of the EXCITE trial (Wolf et al., 2006) and considered whether pain and fatigue increased following CIMT. Fatigue was significantly greater in the afternoon, compared to the morning, but pain was not. There was no relationship between either pain or fatigue and change in motor function or with time in therapy in the sub-acute group of participants.

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Three of the original studies reported follow-up assessments at 12 months (Brogårdh et al., 2009; Krawczyk et al., 2012; Wolf et al., 2006). Two published their findings in a supplementary paper (Brogårdh & Lexell, 2010; Wolf et al., 2008). Wolf et al. (2006) found the log of WMFT

performance time and MAL (AOU and QOM) to be significantly better for the CIMT group than the customary care group at 12 months. Whilst the WMFT functional ability was significantly better for the CIMT group post-intervention, this was not the case at 12 months. The effects gained at 12 months for the WMFT performance time and MAL were maintained or improved at 24 months follow-up (Wolf et al., 2008).

Activity and participation UL outcomes (Sollerman Hand Function Test, Rivermead Motor Assessment Arm Scale and MAL) were maintained or improved at 12 months compared to post- intervention (Brogårdh et al., 2009; Krawczyk et al., 2012) and three month follow-up (Brogårdh et al., 2009), with no significant differences between a ‘constraint’ and ‘no constraint’ group.

3.4.2.4 Which of the CIMT protocols are effective in increasing UL function in sub-acute stroke survivors?

Eleven different protocols (Table 3.2) were described in the 13 original studies, with variations in the amount of daily training, the amount of daily constraint and the total number of days of CIMT. Some evidence of effectiveness has been found for all the CIMT protocols. However, for two protocols, one hour therapy, three times a week for 10 weeks with five hours constraint wearing (Atteya, 2004; Page et al., 2002b; Page et al., 2001), and two hours therapy, five days a week for two weeks with 10 hours a day constraint wearing (Singh & Pradhan, 2013) this evidence is considered weak due to the high risk of bias. In addition, in seven studies (Brogårdh et al., 2009; Brunner et al., 2012; Hammer & Lindmark, 2009a; Krawczyk et al., 2012; Treger et al., 2012; van Delden et al., 2013; Wang et al., 2011), the evidence indicates that CIMT is only as

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effective as an alternative intervention. No study indicates that CIMT is less effective in increasing UL outcomes than a comparative intervention. Due to the variation in research design and CIMT protocols, the current evidence is not sufficient to identify which protocols are most effective in the sub-acute phase of stroke.