Advice
Clinical and technical evidence
Clinical and technical evidence
A literature search was carried out for this briefing in accordance with the interim process and methods statement. This briefing includes the most relevant or best available published evidence relating to the clinical effectiveness of the technology. Further information about how the evidence for this briefing was selected is available on request by contacting mibs@nice.org.uk.
Published evidence
Four observational studies (2 before-and-after, 2 comparative) including 113 patients with stroke-related dysphagia are summarised in this briefing.
Clinically relevant outcomes reported include results of oropharyngeal motor function testing (function of the lips, jaw, tongue, and velum; lip force; velopharyngeal closure ability), swallowing capacity testing and facial activity testing for facial dysfunction.
Table 1 summarises the clinical evidence as well as its strengths and limitations.
Overall assessment of the evidence
All of the included studies were authored by the owner of the IQoro patent. All studies were done in Sweden in either a home setting or centre for speech and swallowing rehabilitation.
The study populations were relatively small and no power calculations were reported to assess for adequate sample size. The inclusion criteria were clear (people with clinically diagnosed dysphagia after a stroke, who were referred to a centre for swallowing and speech rehabilitation). There was, however, significant individual variability within the study populations for time between stroke and start of training (between 2 days and 10 years over all groups). Most patients with dysphagia after a stroke recover spontaneously over time, though 11% to 50% still have dysphagia at 6 months (Cohen et al. 2016), therefore spontaneous improvement may have been a confounding factor.
No statistical analysis was done in the 2 comparative studies on whether the groups were adequately matched. In both comparative studies, the study groups were recruited during different periods and were not assessed at the same time which may add sources of bias, but the clinical teams and standard care pathways were consistent. No information is given about the type, severity or location of stroke, which may affect the likelihood and speed of recovery.
None of the studies included a standard care group or a group with no intervention as a control. This would help compare the effect of IQoro with spontaneous improvement. The comparator in 2 studies (the palatal plate) is not typically used in the UK as part of standard care. However, Hägg and Tibbling (2016) found similar improvements in oropharyngeal motor function and mean swallowing capacity regardless of whether the patient group had early or late intervention. The authors noted that if spontaneous improvement was a factor, it would be more prevalent in the early-intervention groups, therefore improvement is likely an effect of IQoro training.
Outcomes were assessed using objective, relevant measures and subjective patient-reported measures. The study authors were blinded from all end-of-treatment assessments. The lip force testing was blinded from all investigators. Outcomes at follow-up were reported on both a shorter-term (for example, 3 months after training began) and a longer-term basis (for example, year after the end of training).
Table 1 Summary of selected studies
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Study size, design and location |
A prospective, before-and-after observational study in people with stroke-related dysphagia (n=30) at a Swedish centre for swallowing and speech rehabilitation (median age 70 years, range 49 to 88, 12 women). Inclusion criteria were: ability to cooperate, to be able to be fed orally and a pathological SC. Data were collected between October 2003 and March 2005. All patients in the early-intervention group had their stroke on average 1 month before treatment (range 2 days to 6 weeks). In the late intervention group patients had suffered stroke on average 2 years before starting treatment (range 2 months to 10 years). A follow-up examination was done between 5 and 8 weeks in 14 patients, after 9 to 24 weeks in 15, and after 1 year in 1 patient. |
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Intervention and comparator(s) |
IQoro 3 times daily for at least 5 weeks, no comparator. Outcomes were assessed before and after treatment. |
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Key outcomes |
The median lip force was 7 Newton (range 0 to 27) before treatment and 18.5 Newton (range 7 to 44) after treatment (p<0.001). The median swallowing capacity increased from 0 ml/s (range 0 to 9.1) before treatment to 12.1 ml/s (range 0 to 36.7) at follow-up (p<0.001). The interval between stroke and start of treatment, ranging from a few days up to 10 years, had no statistically significant influence on the treatment results, nor did age or gender. |
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Strengths and limitations |
There was no difference in lip force or SC between early or late intervention groups suggesting that recovery was not only because of spontaneous improvement, but the presence of a comparator treatment would have made this clearer. No power calculation is reported. |
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Study size, design and location |
A prospective, comparative observational study in people with stroke-related dysphagia (n=26) in Sweden in a home setting (median age 69 years, range 55 to 81, 9 women). Inclusion criteria were: patients suffering from their first-ever stroke, diagnosis of dysphagia according to a referring clinician. Data were collected from 1997 to 2002 in the PP group (n=12) and from 2003 to 2008 in the IQoro group (n=14). Training lasted for 13 weeks. Patients in the PP group started training at a median of 20 months (range 1 to 69) after stroke. In the IQoro group, 7 patients started training within 3 weeks after stroke and 7 patients began training on average 12 months (range 1 to 108) after stroke. A follow-up examination was done after 13 weeks and again an average of 22 months after completion of training in the PP group, and on average 13 months after completion of training in the IQoro group. |
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Intervention and comparator(s) |
IQoro (3 times per day for 30 seconds before a meal) compared with PP (3 times per day for 10 to 30 minutes before a meal). |
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Key outcomes |
Normal swallowing capacity was restored in 33% of the PP group, and in 71% of the IQoro group. There was a greater median SC improvement in the IQoro group compared with the PP group in the period from baseline to late follow-up (an increase of 11.6 ml/s compared with 5.0 ml/s, p<0.002). Patient self-assessed improvement tested at baseline and at end of treatment did not differ significantly between the 2 groups. |
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Strengths and limitations |
Patients were recruited prospectively but were not contemporaneous. No power calculation is reported. The median length of the time between stroke and start of training was several months longer in the PP group than in the IQoro group. The authors recorded the training compliance, noting that training compliance was optimal in both groups and could reasonably not have had any influence on the difference of training results. |
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Study size, design and location |
A prospective, comparative observational study in people with stroke-related dysphagia (n=31) in a Swedish centre for swallowing and speech rehabilitation and the home setting. Inclusion criteria were: patients suffering from their first-ever stroke and a diagnosis of dysphagia according to referring physicians. Patients were either allocated into the IQoro group (n=18, median age 66 years [range 53 to 81 years], 9 women) or a PP group (n=13, median age 68 years [range 46 to 82 years], 2 women). Patients were included during 2 periods: 13 patients between 2005 and 2008 trained with a PP, while 18 patients between 2009 and 2012 trained with an IQoro. Training began a median of 5 weeks after stroke in the IQoro group and 59 weeks after stroke for the PP group. Follow-up examination was done after 3 months training and at a later follow-up (at least 1 year after the end of training). |
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Intervention and comparator(s) |
IQoro (3 times per day for 30 seconds before a meal) compared with PP (3 times per day for 10 to 30 minutes before a meal) over 3 months. |
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Key outcomes |
FA and SC statistically significantly improved (p<0.001) in both groups, however no statistically significant differences were found between the 2 training modalities in terms of improving facial dysfunction and dysphagia in patients after stroke. |
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Strengths and limitations |
Patients were recruited prospectively but were not contemporaneous. No power calculation is reported. |
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Study size, design and location |
A prospective, before-and-after observational study in people with stroke-related dysphagia (n=26) in a Swedish centre for swallowing and speech rehabilitation and a home setting (median age 68 years, range 49 to 82, 11 women). Inclusion criteria were: patients suffering from their first-ever stroke and a diagnosis of dysphagia according to referring physicians. Group 1 comprised patients included in a first period (more than half a year after stroke; n=15, median age 67 years) and group 2 comprised patients included in a second period (within 1 month after stroke; n=11, median age 69 years). Patients in group 1 started IQoro training a median of 48 weeks (range 24 to 520 weeks) after stroke. Patients in group 2 started training a median of 3 weeks after the stroke event (range 1 to 4 weeks). Patients assessed before and after 3 months of IQoro training and at a later follow-up (median 59 weeks after end of training). 4 patients in the late- and 1 in the early-intervention group presented at baseline with PEG feeds and were unable to eat or drink orally. |
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Intervention and comparator(s) |
IQoro, 3 times each day for 30 seconds, 3 times per day before a meal, no comparator. Outcomes were assessed before and after treatment, and at late follow-up. |
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Key outcomes |
Statistically significant improvement in postural control and OPMD measures was seen after the completion of IQoro training in both intervention groups (p<0.01). The improvements were still present at the later follow-up (p<0.01). At end of training all 5 people with PEG feeds were on normal, oral diets including the ability to drink water. There was no statistically significant difference in improvement measures between group 1 and 2 (p>0.05). |
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Strengths and limitations |
There was no significant difference between early or late intervention groups suggesting that recovery was not only because of spontaneous improvement, but the presence of a comparator treatment would have made this clearer. No recruitment dates are reported. There is a small sample size and no power calculation is reported. |
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Abbreviations: FA, facial activity; OPMD, oropharyngeal motor dysfunction; PEG, percutaneous endoscopic gastrostomy; PP, palatal plate; SC, swallowing capacity. |
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Recent and ongoing studies
Swallowing Function, Oral Health, and Food Intake in Old Age (SOFIA). ClinicalTrials.gov identifier NCT02825927. Completed November 2017, awaiting publication.