PRIMER RELATO

Studies indicate that retention to CIMT research is good with a large study (N=222) of sub-acute stroke survivors undertaking the original protocol (six hours of training each weekday for two weeks and constraint wearing for 90% of waking hours) having a retention rate of 76.1% of participants at 12 months (Wolf et al., 2006). Additionally, a study of stroke survivors less than 28 days post-stroke undertaking a reduced protocol (two or three hours of training and six hours or 90% of waking hours of restraint) maintained a retention rate of 96% of participants at 90 days (Dromerick et al., 2009). The recruitment rate is less clear. Taub et al. (1993) noted that

approximately 18% of chronic stroke survivors identified from physicians’ files met the inclusion criteria of more than one digit with 10ᵒ active range of extension at the metacarpophalangeal (MCP) and interphalangeal (IP) joints and 20ᵒ at wrist joint, without severe cognitive deficits or

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spasticity. By contrast, Brunner et al. (2011) found 21 out of 100 stroke survivors in an in-patients setting were found to meet CIMT inclusion criteria at one to two weeks post stroke; however, this dropped to 14 after four weeks, and six at three months. This reduction over time was due to increased function in the majority of cases and is supported by the EXCITE trial (Wolf et al., 2006) where only 6% of those screened (three to nine months post stroke) were ultimately recruited to a protocol including six hours of daily training. The VECTORs study (Dromerick et al., 2009) recruited only 3% of stroke survivors who were less than 28 days post-stroke. The difference in recruitment rate between the VECTOR study and the work by Brunner et al. (2011) may be explained by additional selection criteria in the VECTOR study including a requirement for

preserved cognition, the ability to perform two step commands, and exclusion of stroke survivors with unilateral spatial neglect or sensory loss. Based on the above evidence, where sub-acute is defined as from 14 days to nine months post stroke, the recruitment rate of sub-acute stroke survivors to a CIMT study is likely to be between 3% and 14%.

Whilst it is possible to extrapolate the evidence to estimate recruitment and retention to CIMT, and a few studies state that provision of CIMT is feasible (Atteya, 2004; Barzel et al., 2009; Page et al., 2001), there has been very little qualitative exploration of the acceptability of the CIMT to stroke survivors and of therapists’ views about the feasibility of providing the intervention.

One study (Page et al., 2002a) reported potential barriers and facilitators to using CIMT, by collecting views by questionnaire from therapists in the United States (US) who had not administered a CIMT protocol, but who did have knowledge of the intervention from in-service training or literature. OTs (n=26) and physiotherapists (n=59) completed the five-point Likert scaled questions; 68% felt that the CIMT protocol would be difficult to administer. A number of potential barriers were noted: length of therapy time (84.7% of participants indicated that the amount of contact time would cause difficulty), fatigue, decreased safety as a result of wearing a

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constraint, transport to therapy, and insufficient resources within the service to administer CIMT. Stroke survivors (N=208) also completed a questionnaire: 68% indicated that they would not participate in CIMT which involved constraining the contralesional UL and undertaking training six hours a day for 10 consecutive weekdays. Reasons cited for not wanting to participate included length of time wearing constraint, number of daily hours of therapy and number of days of therapy. Whilst this study does provide some useful insights, data collected by questionnaire is restricted by the pre-determined questions, potentially limiting scope and detail of the findings.

One study (Gillot et al., 2003) utilised a phenomenological approach to explore the perceptions and experiences of CIMT of two chronic stroke survivors. The study used quantitative measures to provide additional description. One stroke survivor undertook the original CIMT protocol with six hours training over two weeks and wore the constraint for about eight hours a day, whilst the other participant, also a stroke survivor, undertook a protocol of three hours training a day for two weeks and ‘occasionally’ wore a constraint. Qualitative data were collected during two interviews, pre-CIMT and post-CIMT. Both participants indicated that they were participating in CIMT to increase the functional use of their contralesional UL. Both participants reported an increase in functional ability, but the participant undertaking the higher intensity protocol reported disappointment in the results, as she had read about CIMT and its “remarkable results” prior to undertaking the protocol. These qualitative data reporting increases in function were supported by descriptive quantitative findings. This study explored perceptions and experiences, but the interviews explored neither the acceptability of CIMT, nor the barriers to or facilitators of CIMT. Whilst the study design aimed to increase rigour through triangulated data, and member checking of the analyses, the independence of those analysing the data was unclear as was the interviewer’s relationship with the participants, impacting negatively on the overall credibility of the study. In addition, this study was undertaken in the US, with chronic stroke survivors. An

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exploration of the acceptability, and the barriers and facilitators of undertaking CIMT in the sub- acute phase of stroke in the UK is required.

Since most therapy occurs in the first few months post-stroke, and much of the rehabilitation will take place in the acute and sub-acute phase of stroke, Wolf et al. (2006) undertook the largest CIMT study (N=222) to date, with stroke survivors three to nine months post stroke. This multi- centred EXCITE trial compared the original CIMT protocol of six hours training for 10 weekdays combined with 90% daily constraint wearing (n=106) with customary care (n=116), in stroke survivors in the sub-acute (three to nine months) phase of stroke, where customary care ranged from no therapy to sessions of undescribed physiotherapy or occupational therapy. Wolf et al. (2006) reported that the CIMT group had significantly greater improvements in WMFT

performance time and functional score than customary care group at post-intervention (ANOVA; p<0.001). The gains were significantly greater for the CIMT group than the customary care group at 12 months for performance time (ANOVA; p<0.01), but not functional score. There were small, but significant between group differences from baseline to 12 months in MAL AOU (SMD 0.43, 95% CI 0.05-0.80, p<0.001) and MAL QOM (SMD 0.48, 95% CI 0.13-0.84, p<0.001). This study was well designed and found some benefits of CIMT over customary care; however, there is a need to systematically review the CIMT evidence in sub-acute stroke to explore whether CIMT is more effective than an equal dose of other types of therapeutic interventions or whether it is the intensity, rather than the type of training, that is important.

Six systematic reviews have undertaken a quality assessment and analysis of CIMT studies post- stroke since 2008 (Corbetta et al., 2010; Nijland et al., 2011; Peurala et al., 2012; Shi et al., 2011; Sirtori et al., 2009; Stevenson et al., 2012). A critical appraisal of these systematic reviews was undertaken. Assessment of the validity and methodological quality was made using the Critical Appraisal Skills Programme (CASP) systematic review checklist (Critical Appraisal Skills

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Programme, 2013) and a checklist based on the Quality of Reporting of Meta-analyses (QUORUM) statement (Moher et al., 1999). The QUORUM checklist was designed, and has subsequently been used, to assess quality in stroke related systematic reviews (Intercollegiate Stroke Working Party, 2012, p. 7). The CASP checklist summarised the validity and relevance of the evidence to a local population, which is important where there is focus on implementation of an intervention (Rycroft-Malone, 2004), whilst the QUORUM checklist provided a numerical score based on the reporting of systematic review methodology. The 10 questions in the CASP and the 21 items on the QUORUM checklist are presented in Appendix 1. A decision about overall risk of bias took into account both assessments; the rating process is described in Table 2.1. The findings from these assessments, along with the main limitations or potential sources of bias which impacted on the quality rating, are presented in Table 2.2.

Table 2.1 Summary of rating process for systematic reviews

Risk of Bias Decision

High risk of bias QUORUM score of < 30 AND

CASP with ≥ 4 identified areas of concern Moderate risk of bias QUORUM score of < 30

AND

CASP with ≤3 identified areas of concern OR

QUORUM score of ≥ 30 AND

CASP with ≥ 4 identified areas of concern Low risk of bias QUORUM score of > 30

AND

CASP with ≤ two identified areas of concern

Where the traditional CIMT protocol has been altered, these protocols are sometimes referred to as modified CIMT (mCIMT) (Brunner et al., 2011; Nijland et al., 2013). As Section 2.2 identified

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that the components of CIMT are not well established, it is likely that each protocol contains ‘modifications’, therefore throughout most of this thesis, the term CIMT has been used for all protocols, and the dose of each protocol described.

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Table 2.2 Summary of CIMT Systematic Reviews (chronological order)

Author Date Included Study Designs and Population Included protocols

Outcomes Findings Comments on

sub-acute phase analyses Risk of Bias Sirtori et al., 2009 19 RCTs and quasi-RCTs N=619 Time post- stroke range: 0-92 months. ≥18 yrs of age; paresis of the UL Included all CIMT and forced use protocols Primary outcome: Disability outcomes (FIM, BI) Secondary outcomes: WMFT, ARAT, AMAT, EMF, AMPS, MAL, FMA, CMII, NHPT, GPT

Comparison of disability post-intervention comprising FIM (5 RCTs) and BI (1 study) n=184. CIMT had a modest significant benefit on disability (SMD 0.36, 95% CI 0.06 to 0.65, Z=2.36, p=0.018). Comparison of disability three and six month follow-up FIM (1 study) and BI (1 study), n=73, effect of CIMT non- significant.

Secondary outcomes indicated an significant effect in favour of CIMT: UL motor function (SMD 0.72, 95% 0.32- 1.12, Z=3.51, p=0.00045) -14 RCTs, n=436. MAL AOU (WMD 0.1.16, 95% 1.05-1.27, Z=20.71, p=0.00001) -16 RCTs, n=541. MAL QOM (WMD 0.87, 95% 0.75-0.98, Z=14.63, p=0.00001) -16 RCTs, n=541. UL motor impairment (SMD 0.65, 95% 0.15-1.15, Z=2.54, p=0.011) -8 RCTs, n=161 0-3 months post stroke (2 studies, n=66) no statistically significant effect size. 3-9 months post stroke group not analysed (no studies used primary outcome)

Moderate risk of bias QUORUM: 34/42 CASP:

-Most included studies had small sample size -Participant & CIMT heterogeneity between studies -Validity of findings to UK unclear Corbetta et al., 2010 18 RCT and quasi-RCTs N=674 Included all CIMT and forced use protocols compared with Primary outcome: disability outcomes (FIM, BI)

Disability outcomes: 8 studies (n=276) measured disability immediately after intervention. CIMT showed no significant effect (SMD 0.21, 95% CI -0.08 to 0.50)

No sub-group analysis for sub- acute phase of stroke

High risk of bias QUORUM: 27/42 CASP:

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Time post- stroke range: 14 days-92 months. other rehabilitative techniques Secondary outcomes: UL function outcomes (ARAT, WMFT, EMF, MAS)

UL function outcomes: 14 studies (n=479). CIMT had a moderate effect on UL function (SMD 0.44, 95% CI 0.03 to 0.84). Substantial heterogeneity (I2_{=63%) found}

for UL function

-Most included studies had small sample size -Participant & CIMT heterogeneity between studies -Relationship with previous systematic review (Sirtori 2009) not clear -Validity of findings to UK unclear Shi et al., 2011 13 papers reporting 12 RCTs N=278 Time post- stroke range: 2 days-60 months ≥18 yrs of age; diagnosis of stroke; ≥10° extension ICP and MCP joints; ≥20° wrist extension; <2.5 on MAL; ≥69 on MMSE CIMT protocols comprised at least 30 mins and not more than 3 hrs training a day, combined with less than 6hrs constraint a day Trials included at least one measure of UL function. The following were reported: FMA, ARAT, FIM, MAL, SIS, kinematic measures

Meta-analysis indicated higher scores in CIMT group vs traditional rehab in: FMA (MD=7.8; 95%CI, 4.21-11.38, Z=4.27, p<0.0001) - 6RCTs, n=116 ARAT (MD=14.15; 95%CI 10.71-17.59, Z=8.07, p<0.00001) - 5 RCTs, n=63 FIM (MD=7.0; 95%CI 0.75-13.26, Z=2.19, p=0.03) – 3 RCTs, n=88 MAL AOU (MD=1.09; 95% CI 0.26- 1.91, Z=2.59, p<0.001) - 6 RCTs, n=173 MAL QOM (MD=1.02; 95% CI 0.55-1.49, Z=4.23, p<0.01) - 6 RCTs, n=173

WMFT – results not pooled as sample size too small

No sub-group analysis for sub- acute phase of stroke

Moderate risk of bias QUORUM: 35/42 CASP:

-Most included studies had small sample size -Participant heterogeneity between studies -Some studies not included that met selection criteria (eg Myint 2008 and Brogardh 2009) -Validity of findings to UK unclear Nijland et al., 2011 5 RCTs N=106 10 weeks post- stroke or less at recruitment CIMT protocols that focussed on UL Not specified which were included, but the following were pooled and reported: FMA, ARAT, MAL, GPT

Significantly greater MD in CIMT group for two measures: FMA (MD=11.0; 95%CI, 2.50-19.49, Z=2.54, p=0.01) - 3 RCTs, n=34. ARAT (MD=7.88; 95%CI 1.09-14.66, Z=2.28, p=0.02) - 3 RCTs, n=82. Theoretically addresses acute and sub-acute phases, but does not include any studies in the 14 days to 9 month

Moderate risk of bias QUORUM: 32/42 CASP:

-Most included studies had small sample size

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≥18 yrs of age Non-significant for MAL AOU and MAL

QOU -3 RCTs, n=34.

GPT (MD 0.05, 95%CI 0.02-0.09, Z=2.86, p=0.004) – 2 RCTs, n=24

Significant mean differences found for FMA and ARAT for low intensity protocols (constraint of less than 90% and less than 3hrs training per day), but not high intensity protocols (restraint of 90% per day and 3hrs or more training per day)

post-stroke range -Small number of eligible studies -High reliance on VECTORS study -Validity of findings to UK unclear Peurala et al., 2011 30 RCTs Sample size not stated Time post- stroke not specified. ≥18 yrs of age Included all UL CIMT protocols, excluded forced use Activity and participation outcomes 27 outcomes reported, most common were MAL, ARAT, WMFT, FIM, SIS (participation item), BI

13 studies included in meta-analysis. Non- significant MD for FIM and SIS, but significant difference in favour of the CIMT group was found for WMFT, MAL, ARAT: WMFT (MD=-0.46; 95%CI -0.59,-0.33, Z=6.93, p<0.00001) – 2 RCTs, n=232. MAL AOU (MD=0.85; 95% CI 0.62- 1.08, Z=7.23, p<0.00001) - 9 RCTs, n=458. MAL QOU (MD=0.73; 95% CI 0.46-0.99, Z=5.40, p<0.00001) - 8 RCTs, n=442. ARAT where CIMT was compared to comparison intervention (MD=7.84; 95%CI 1.60-14.08, Z=2.46, p=0.01) - 5 RCTs, n=154.

ARAT where CIMT is compared to no treatment (MD=15.34; 95%CI 4.05-26.63, Z=2.66, p=0.008) - 1 RCTs, n=23

No sub-group analysis for sub- acute phase of stroke

Moderate risk of bias QUORUM: 27/42 CASP:

-Most included studies had small sample size -Participant heterogeneity between studies -Validity of findings to UK unclear

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Stevenson et al., 2012 22 RCTs N=665 Time post- stroke not specified Adult stroke survivors Included all UL CIMT protocols. Studies included if CIMT compared do a dose-matched control group supervised therapy of equal time to CIMT training) UL capacity: FMA, kinematic analyses of movement, indirect indicators of neuro- physiological mechanisms. UL ability: ARAT, NHPT, WMFT, FIM, BI Comprehensive function: FIM, BI Self-repoerted measures: MAL

Significant effect in favour of CIMT in: UL capacity (SMD=0.47, 95%CI, 0.27- 0.66)-15 RCTs

UL ability (SMD=0.80, 95%CI, 0.57-1.02)- 14 RCTs

FIM (MD=5.05, 95%CI, 2.23-7.87)-6 RCTs MAL AOU (MD=1.05, 95%CI, 0.85-1.24)- 12 RCTs

MAL QOM (MD=0.89, 95%CI, 0.69-1.08)- 11 RCTs Compared studies >6months & <6 months post- stroke. Found no significant difference in UL capacity, UL ability or comprehensive function

Moderate risk of bias QUORUM: 32/42 CASP:

-Did not include studies that

compared CIMT with a constraint and similar training without constraint (eg Hammer, Brogardh) -Most included studies had small sample size -Participant & CIMT heterogeneity between studies -Validity of findings to UK unclear

AOU Amount of use

ARAT Action Research Arm Test BI Barthel Index

CI confidence interval

CIMT Constraint induced movement therapy EMF Emory Function Test

FIM Functional Independence Measure FMA Fugl-Meyer Assessment

GPT Grooved Peg Test hr hour

IP interphalangeal joint MAL Motor Assessment Log

mCIMT Modified constraint induced movement therapy MCP meta-carpophalangeal joint

MD mean difference Min minute

MMSE Mini Mental State Examination QOM Quality of movement

RCT Randomised Controlled Trial SIS Stroke Impact scale

SMD standard mean difference UL Upper limb

WMD Weighted mean difference WMFT Wolf Motor Function Test

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Systematic reviews that included participants across the acute, sub-acute and chronic phases of stroke (Corbetta et al., 2010; Peurala et al., 2012; Sirtori et al., 2009; Stevenson et al., 2012) have found CIMT (where the evidence includes both the original and modified CIMT protocols) to be effective in improving UL function (Corbetta et al., 2010; Peurala et al., 2012; Stevenson et al., 2012) even when compared to a dosed-matched intervention (Stevenson et al., 2012). The picture is less clear for disability outcomes, measured by the Functional Independence Measure (FIM) and Barthel Index (BI). Four systematic reviews addressed disability (Corbetta et al., 2010; Shi et al., 2011; Sirtori et al., 2009; Stevenson et al., 2012), three systematic reviews of moderate quality found benefit of CIMT in reducing disability (activity limitation) compared to alternative interventions (Shi et al., 2011; Sirtori et al., 2009) and dose-matched interventions (Stevenson et al., 2012), whilst a lower quality systematic review (Corbetta et al., 2010) found there to be no beneficial effect on FIM. This review did, however, have a higher proportion of studies in the acute and sub-acute phase of stroke than the other reviews, which may have impacted the outcome. In addition one study (Sirtori et al., 2009) found the benefit on disability was lost at three and six months post-intervention.

Lower intensity CIMT (30 minutes to three hours training with less than six hours restraint a day) appears to be more effective than traditional rehabilitation (Shi et al., 2011) in regaining ability to use the contra-lesional UL, although it is not known whether it is more effective than an intensity equivalent rehabilitation. Stevenson et al. (2012) found a benefit of CIMT (combining higher and lower intensity protocols) in increasing UL function compared to dose-matched interventions; however, studies that compared CIMT to an intervention comprising similar training, but without a restraint were not included, therefore, several potentially relevant studies were excluded (Brogårdh et al., 2009; Hammer & Lindmark, 2009a), which may have impacted on the findings in that review.

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There is evidence that CIMT (where the evidence includes both the original and modified CIMT protocols) is effective in increasing UL activity in the first three weeks post stroke (Nijland et al., 2011), with some indicators that, in this group, lower intensity CIMT (less than three hours a day training and constraint for less than 90% of waking hours) may be more effective than higher intensity CIMT (three hours or more training a day and constraint for 90% of waking hours). This is contrary to the findings of Sirtori et al. (2009) who concluded that there was no significant difference between a total of 30 hours or less therapy compared to a total of more than 30 hours of therapy. This discrepancy is likely to be a consequence of the differences in the time post- stroke of the participants in the included systematic reviews. It is not yet known if some

protocols are more effective than other protocols for a given stroke survivor; it may be that time post-stroke is an important factor when selecting a CIMT protocol.

It is unclear from the previous systematic reviews whether CIMT, either the original protocol or a modified version, is effective in increasing upper limb function in a sub-acute phase of stroke, defined as 14 days to nine months post-stroke. Three systematic reviews (Nijland et al., 2011; Sirtori et al., 2009; Stevenson et al., 2012) purport to address the sub-acute phase of stroke. Nijland et al. (2011) theoretically included participants from the acute and sub-acute phase of stroke; however, four of the five studies included only participants who were less than 14 days post-stroke on recruitment, whilst only one study included participants who were up to 21 days post-stroke. The majority of the data summarised in that systematic review relates to the acute rather than the sub-acute phase of stroke. Two systematic reviews considered whether there was a difference in response to CIMT depending on time post-stroke. Based on two heterogeneous

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