| Study | Reason for exclusion |
|---|---|
| Akamatsu 2009 | RCT assessing transcutaneous electrical stimulation vs control 12 participants with chronic stroke and episodes of choking while eating or drinking Outcome: latency time in swallowing reflex Excluded: no relevant outcome data |
| Aoki 2016 | Study looking at effect of implementing multi‐disciplinary swallowing team approach in lowering the rate of pneumonia (between‐team organisation vs after‐team organisation) Outcomes: rates of pneumonia Excluded: not a true RCT |
| Arai 2003 | RCT Group 1: cabergoline (n = 13) Group 2: amantadine (n = 14) Group 3 : ACE inhibitor (n = 12) Group 4: control Excluded: (1) > 3 months post stroke; (2) definition of aspiration non‐standard; (3) randomisation unclear; (4) insufficient information |
| Beom 2011 | Study comparing conventional dysphagia management (CDM) vs CDM with repetitive electrical stimulation of the suprahyoid muscles Outcomes: swallow score Excluded: not true RCT ‐ non‐concurrent comparative design |
| Beom 2015 | Randomised trial in dysphagic participants with stroke, traumatic brain injury, or brain tumour NMES on suprahyoid (Stimplus) vs NMES on suprahyoid and infrahyoid (VitalStim) Outcomes: swallow scores Excluded: confounded ‐ comparison between 2 treatment groups |
| Byeon 2016 | Randomised trial comparing neuromuscular electrical stimulation vs thermal‐tactile stimulation in subacute stroke patients with dysphagia Outcomes: swallow scores (Functional Dysphagia Scale using VFSS) Excluded: confounded ‐ comparing 2 active treatments |
| Bülow 2008 | RCT assessing neuromuscular electrical stimulation vs traditional swallowing therapy in 25 stroke patients with dysphagia Outcomes: video radiographic swallowing evaluation, nutritional status, oral motor function test, visual analogue scale for self‐evaluation of complaints Excluded: (1) no available outcome data, (2) confounded, comparing 2 direct treatments |
| Cai 2015 | Randomised trial comparing tongue acupuncture vs conventional (neck and wrist) acupuncture in post‐stroke dysphagia patients Outcomes: dysphagia at end of trial, NIHSS, pneumonia Excluded: (1) confounded ‐ both groups received active treatment |
| Chaudhuri 2006 | RCT assessing effectiveness of electric stimulation vs traditional dysphagia therapy in participants with acute stroke (< 6 weeks) Outcomes: American Speech Language Hearing Association National outcome measurement system swallowing level Excluded: no available outcome data |
| Chen 2002 | RCT assessing tongue acupuncture + ice massage + general medical treatment (n = 50) vs general medical treatment (n = 46) in acute dysphagic stroke patients Outcome: dysphagia recovery assessed by videofluoroscopy Excluded: no available outcome data |
| Chen 2003 | RCT assessing electroacupuncture + rehabilitation (n = 34) vs rehabilitation alone (n = 34) in dysphagia patients with pseudobulbar palsy including stroke Treated for 10 days Outcome: dysphagia recovery after stroke Excluded: no available outcome data |
| ChiCTR‐ONC‐17012326 | RCT examining effects of acupuncture and rTMS for acute patients ‐ duration of stroke and dysphagia between 1 and 6 months. Outcomes: VFSS score Excluded: confounded ‐ comparing acupuncture and rTMS |
| ChiCTR‐TRC‐14005233 | RCT comparing validity and safety of telerehabilitation (exercise rehabilitation and myoelectrical feedback) vs conventional rehabilitation in dysphagic patients with ischaemic cerebral stroke Outcomes: Barthel Index assessment; NIHSS assessment; water drinking test assessment; surface electromyography Excluded: confounded ‐ comparing 2 active treatment groups |
| DePippo 1994 | RCT comparing 3 active interventions in 115 dysphagic stroke patients taught compensatory swallowing techniques Group 1: patient/family choice of diet and food consistency (n = 38) Group 2: therapist‐prescribed diet and food consistency (n = 38) Group 3: therapist‐prescribed diet and food consistency, with daily reinforcement of compensatory swallowing techniques (n = 39) Outcomes: pneumonia, dehydration, caloric‐nitrogen deficit, death Excluded: 3 active treatment groups with no control group (confounded) |
| Dou 2012 | Randomised trial comparing effects of active vs passive balloon dilatation therapy on swallowing function in participants with cricopharyngeal dysfunction due to neurological disorders Outcomes: swallow score, changes in upper oesophageal sphincter opening Excluded: confounded ‐ comparison between 2 active treatments |
| Ebihira 2004 | RCT Group 1: theophylline 200 mg once daily Group 2: placebo N = 85 with 'mild to moderate' dysphagia (definition unclear) Outcome: latency of swallow Excluded: (1) nursing home residents (not acute), proportion of stroke patients not stated; (2) > 3 months post stroke |
| Ebihira 2005 | RCT Group1: capsaicin troche 1.5 mcg (n = 34) Group 2: placebo (blinded) (n = 33) for 4 weeks Excluded: (1) 'predominantly' stroke (% not stated) nursing home‐dependent residents; (2) definition of dysphagia unclear; (3) > 3 months post stroke; (4) outcomes: latency of swallow not relevant to review |
| El‐Tamawy 2015 | RCT evaluating effects of a designed physical therapy programme that consists of therapeutic physical exercises in addition to neuromuscular electrical stimulation on severe swallowing disorders (oropharyngeal dysphagia) in people with acute ischaemic cerebrovascular stroke Outcomes: oral transit time, hyoid/laryngeal elevation, oesophageal sphincter opening, incidence of penetration and aspiration Excluded: no available outcome data |
| Fraser 2002 | RCT including 16 acute stroke (< 4 days from ictus) participants with dysphagia TMS vs none Outcome: pharyngeal electromyographic responses Excluded: no relevant outcome data |
| Freed 1996 | Controlled clinical trial comparing 3 active interventions in 112 participants with aspiration Group 1: electrical stimulation Group 2: thermal stimulation Group 3: both ‐ failed thermal stimulation followed by electrical stimulation Outcome: regain oral intake Excluded: (1) dysphagia of mixed aetiology (stroke ?%); (2) not an RCT; (3) 2 active treatment groups with no control group (confounded) |
| Freed 2001 | Quasi‐RCT (alternate assignment) comparing electrical stimulation vs thermal‐tactile stimulation in 110 dysphagic stroke patients Outcome: swallow score Excluded: (1) 2 active treatment groups with no control group (confounded) |
| Hagg 2015 | Prospective comparative study of 2 groups of post‐stroke 4‐quadrant facial dysfunction and dysphagic patients ‐ palatal plate training (2005‐2008) vs training with oral IQoro® (2009‐2012) Outcome: facial activity, swallow function Excluded: (1) not a true RCT, (2) confounded ‐ comparing 2 active treatment protocols |
| Inui 2017 | Quasi‐experimental study to compare the incidence of pneumonia as a dependent variable between before (control) and after (intervention group) intervention with pyriform sinus suctioning as an independent variable Outcomes: incidence of pneumonia Excluded: (1) not an RCT ‐ not randomised |
| ISRCTN18137204 | RCT comparing electrical pharyngeal stimulation vs sham stimulation in severely dysphagic tracheotomised stroke patients Outcomes: intention to decannulate based on FEES performance; feeding status at discharge (dysphagia severity rating scale, functional oral intake scale); mRS; length of stay (ICU/hospital), time from stimulation to discharge Excluded: outcomes not relevant to the review |
| ISRCTN97286108 | RCT assessing dose response of transcranial direct current stimulation for dysphagia after acute stroke Outcome: swallow safety Excluded: trial terminated due to problems in recruitment (according to study author) |
| Jin 2014a | RCT assessing effects of magnetic‐ball sticking therapy at auricular points against acupuncture in 90 participants with chronic post‐stroke dysphagia Outcomes: swallow score (VFSS), PAS, pneumonia, malnutrition Excluded: (1) confounded ‐ all participants received treatment, (2) duration of stroke unknown |
| KCT0001907 | Study looking at effects of NMES according to electrode placement in stroke patients with dysphagia Outcomes: videofluoroscopic dysphagia scale; PAS; functional oral intake scale Excluded: (1) confounded (comparing electrode placement on suprahyoid vs infrahyoid), (2) time post onset unclear |
| Kikuchi 2014 | Double‐blind RCT on participants > 65 years old with stroke and dysphagia from 2 hospitals and 2 nursing homes in Sendai, Japan Group 1: press needles (Pyonex; Seirin Corporation, Shizuoka, Japan) at 2 points on the legs (ST36 and KI3) Group 2: sham patches on acupuncture points Group 3: press needles on sham points Excluded: no relevant outcomes |
| Kobayashi 1996 | Randomised crossover trial assessing levodopa in 27 participants with basal ganglia infarction and 20 healthy volunteers Outcomes: swallowing latency Excluded: (1) cross‐over trial, (2) outcomes (swallowing latency) not relevant to this review, (3) < 50% stroke |
| Kulnik 2015 | Single‐blind RCT in acute stroke patients Expiratory training vs inspiratory training vs sham training Outcomes: peak expiratory cough flow of maximal voluntary cough, pneumonia Excluded: most participants do not have clinical dysphagia |
| Kushner 2013 | Case‐control study comparing the efficacy of NMES in addition to traditional dysphagia therapy including progressive resistance training vs that of traditional dysphagia therapy/progressive resistance training alone in participants with acute post‐stroke dysphagia Outcomes: swallow score, dysphagia at end of trial Excluded: non‐randomised trial |
| Lan 2013 | Single‐blind clinical intervention trial comparing biomechanical properties of swallowing in brainstem stroke patients with dysphagia following modified balloon dilation therapy vs regular dysphagia therapy Outcomes: Functional Oral Intake Scale, pharyngeal maximum pressures and duration, and upper oesophageal sphincter residual pressure and duration during swallowing were measured using high‐resolution manometry Excluded: non‐randomised trial |
| Logemann 2009 | RCT assessing traditional swallowing therapy or the Shaker exercise in participants with prolonged oropharyngeal dysphagia and aspiration Outcomes: occurrence of aspiration (preswallow, intraswallow, postswallow) at 6‐week follow‐up period; occurrence of residue in the oral cavity, valleculae, or pyriform sinuses; Performance Status Scale for Diet Excluded: (1) head and neck cancer and stroke (< 50%); (2) no relevant outcome data |
| Ma 2014 | Randomised trial comparing acupoint injection, neural electrical stimulation, combination of both and swallowing training Outcomes: swallow function using water swallow test Excluded: confounded ‐ comparing 3 active treatments |
| Ma 2015 | Randomised trial comparing effects of acupuncture and neck‐skin electrical stimulation on dysphagia in participants with cerebral infarction Outcomes: swallow function using water swallow test and food‐intake scale Excluded: confounded ‐ comparing 2 active treatments |
| Maeda 2017 | RCT 43 participants who were prescribed in‐hospital dysphagia rehabilitation (most with history of stroke) Sensory stimulation vs sham stimulation Outcomes: cough latency times, functional oral intake scale scores, oral nutritional intake Excluded: (1) majority of participants without stroke (48.8% stroke participants), (2) timing of stroke unclear |
| Mao 2016 | Non‐randomised interventional study Standard swallowing training vs standard swallowing training with acupuncture All participants with post‐stroke dysphagia Excluded: not an RCT ‐ not randomised |
| McCullough 2012 | Cross‐over study investigating effects of intensive exercise using Mendelsohn manoeuvre on swallowing movement All 18 participants with stroke and dysphagia Outcomes: videofluoroscopic swallow assessment, swallow score Excluded: (1) not a true RCT ‐ cross‐over design, (2) majority of participants chronic |
| McCullough 2013 | Cross‐over study assessing effect of Mendelsohn manoeuvre on hyoid movement All 18 participants with post‐stroke dysphagia Outcomes: assessment of hyoid movements, upper oesophageal sphincter opening Excluded: (1) not a true RCT ‐ cross‐over design, (2) no relevant outcomes |
| Mepani 2009 | RCT comparing traditional swallowing therapy vs Shaker exercise in 6 stroke and 5 cancer patients Outcome: deglutitive thyrohyoid shortening before and after completion of assigned therapy regimen Excluded: (1) no time of onset for stroke patients, (2) no separate results for stroke, (3) no relevant outcome data |
| Messaggi‐Sartor 2015 | RCT comparing effects of short‐term inspiratory and expiratory muscle training on respiratory muscle strength in subacute stroke patients Outcomes: respiratory muscle strength (maximum inspiratory and expiratory pressures) Excluded: (1) outcomes not relevant to review, (2) not all participants had dysphagia |
| Michou 2010 | RCT comparing transcranial magnetic stimulation vs sham stimulation in 12 stoke participants with dysphagia Outcome: pharyngeal electromyographic responses Excluded: no relevant outcome data |
| Michou 2011 | RCT comparing transcranial magnetic stimulation vs pharyngeal electrical stimulation vs paired associative stimulation vs sham stimulation in 14 dysphagic stroke participants Outcome: videofluoroscopic swallowing assessments Excluded: no available outcome data |
| Nakamura 2013 | Cross‐over study assessing the effect of ice massage in triggering the swallow reflex Outcomes: videofluoroscopic assessment of swallowing Excluded: not a true RCT ‐ cross‐over design |
| Nakayama 1998 | RCT comparing 5 mg imidapril or placebo in randomised, double‐blind, cross‐over design. Participants were normotensive patients with at least 1 episode of aspiration and healthy volunteers Outcome: swallowing reflex Excluded: no relevant outcome data |
| Nam 2012 | Randomised trial comparing 2 neuromuscular stimulation techniques (VitalStim vs Stimplus DP 200) Outcomes: swallow function using videofluoroscopic swallowing studies Excluded: confounded ‐ comparison of 2 treatment groups |
| NCT00376506a | Implanted neuroprosthesis (neuro control implantable receiver‐stimulator) to stimulate the laryngeal nerve vs sensory training in dysphagic participants including stroke > 6 months post onset Excluded: (1) no control group, 2 active groups compared, (2) no outcome data |
| NCT00376506b | RCT assessing intramuscular stimulation device implanted in the neck vs vibrotactile stimulation of the throat in 20 participants with dysphagia secondary to stroke or chronic neurological disease Outcome: swallowing safety for 10 mL of thin liquid and 5 mL of pudding with and without stimulation Excluded: comparing 2 active treatments vs no control (confounded) |
| NCT01971320 | Single‐blind RCT comparing active vs fake Urostim I stimulation in hemispheric stroke patients with oropharyngeal dysphagia Outcomes: evaluation of oropharyngeal dysphagia symptoms Excluded: no outcome data as trial terminated due to lack of recruitment |
| Nishiyama 2010 | RCT comparing nicergoline (15 mg tds) vs control in 50 ischaemic stroke patients Outcome: substance P level Excluded: no relevant outcome data |
| Ortega 2016 | RCT comparing 2 x 10‐day treatment groups (transient receptor potential vanilloid 1 agonist vs transcutaneous sensory electrical stimulation) Outcomes: swallow function (videofluoroscopic), dysphagia at end of trial Excluded: (1) < 50% participants with stroke ‐ duration unknown, (2) confounded ‐ comparing 2 active treatments |
| Permsirivanich 2009 | RCT Group 1: NMES (n = 12) Group 2: rehabilitation swallowing therapy (n = 11) All stroke Excluded: confounded, i.e. comparison of 2 active treatments |
| Pownall 2008 | RCT assessing thickened fluids vs postural and/or swallowing strategies in 50 participants with post‐stroke dysphagia: a further group of participants who were not dysphagic for liquids and who were given normal fluids compared with RCT Outcome: development of chest infection and dehydration Excluded: no control group ‐ 2 interventional groups were compared in the RCT |
| Pryor 2011 | RCT comparing NMSE vs vibrotactile stimulation in dysphagic participants Outcomes: swallow function, PAS Excluded: (1) mixed patient population, (2) confounded ‐ comparison of 2 active interventions |
| Reidnauer 2006 | RCT comparing vital stimulation (and electrotherapy intervention) vs traditional treatment in post‐stroke participants with dysphagia Outcomes: swallow scores Excluded: no available outcome data |
| Rofes 2014 | Double‐blind RCT comparing effects of 2 doses of piperine (dual TRPV1/TRPA1 agonist) on the swallow response of dysphagic participants Participants were randomised into 2 groups: 1 group received 150 lM piperine and the other group received 1 mM Outcome: PAS, swallowing analysis with videofluoroscopic images Excluded: dose‐response trial ‐ all groups received treatment (either low or high dose of piperine) |
| Rosenbek 1991 | Randomised cross‐over trial assessing thermal stimulation in 7 male dysphagic participants with multiple previous strokes Outcome: duration of stage transition Excluded: (1) cross‐over trial, (2) most participants recruited > 3 months after stroke onset, (3) randomisation status unclear |
| Rosenbek 1996 | Randomised cross‐over trial assessing thermal stimulation in 23 dysphagic participants with multiple previous strokes Outcome: duration of stage transition, total swallow duration Excluded: (1) cross‐over trial, (2) 14 participants recruited > 3 months after stroke onset |
| Rosenbek 1998 | Dose comparison RCT of thermal stimulation (150, 300, 450, 600 trials per week) in 45 dysphagic stroke participants recruited within 12 weeks Outcome: number of trials delivered, treatment time, duration of stage transition, aspiration (PAS) Excluded: no control group |
| Sdravou 2012 | Interventional study comparing effects of carbonated thin liquids vs non‐carbonated thin liquids on oropharyngeal swallowing in adults with neurogenic dysphagia Outcomes: oral transit time, pharyngeal transit time, PAS Excluded: (1) non‐RCT, (2) many participants with chronic stroke (> 6 months) |
| Seki 2005 | Randomised trial Group 1: acupuncture (n = 18) Group 2: no intervention (n = 14) Excluded: (1) incomplete outcome data, (2) time from stroke unclear |
| Shaker 2002a | RCT comparing head‐raising exercise vs sham exercise in 27 dysphagic participants Outcomes: upper oesophageal sphincter function, functional swallow status Excluded: (1) dysphagia of mixed aetiology (cerebrovascular disease 56%), (2) most participants recruited > 3 months after stroke onset, (3) individual patient data unavailable, so not possible to analyse subgroup of appropriate participants |
| She 2014 | RCT comparing acupuncture in 8 neck‐occiput points vs meridian points Outcomes: speech and swallowing dysfunction at end of trial Excluded: (1) confounded ‐ comparing 2 different treatment groups |
| SQACU01 2001 | RCT comparing acupuncture vs sham acupuncture for 16 sessions in participants with dysphagia due to recent stroke Outcomes: tube feeding, pneumonia, mortality, each at 6 months Excluded: no outcome data |
| Steele 2016 | RCT comparing 2 treatment protocols: tongue pressure profile training or tongue pressure strength‐and‐accuracy training Outcomes: swallow function Excluded: confounded ‐ comparison between 2 treatment protocols |
| Sukthankar 1994 | RCT assessing swallowing therapy (biofeedback) in 9 participants with dysphagia secondary to stroke or head injury
Group 1: regular therapy (n = 4)
Group 2: regular therapy and oral exercises (n = 2)
Group 3: regular therapy and oral exercises with visual and audio biofeedback (n = 3) Excluded: (1) dysphagia of mixed aetiology, (2) outcome measures (tongue and lip motor force) not relevant to this review |
| Suntrup 2015 | RCT comparing electrical pharyngeal stimulation vs sham stimulation (control) in severely dysphagic tracheotomised stroke participants Outcomes: ability to decannulate based on FEES performance; feeding status at discharge (FOIS); mRS; length of stay (ICU/hospital) and time from stimulation to discharge Excluded: outcomes (decannulation) not relevant to review (only data regarding decannulation available before trial unblinded) |
| Suzuki 2012 | Randomised trial investigating the relationship between body position during nasogastric feed and aspiration pneumonia in acute stroke participants Outcomes: aspiration pneumonia rates Excluded: pseudo‐randomised study; assessment of body position |
| Tai 2014 | Quasi‐experimental trial to investigate effectiveness of the chin‐down swallowing technique in improvement of dysphagia in stroke participants Outcomes: Dysphasia Assessment Scale and Swallow Self‐assessment Excluded: not an RCT ‐ not randomised |
| Teramoto 2008 | RCT assessing swallowing function using cilostazol vs placebo in 48 participants with dysphagia secondary to stroke Outcome: swallowing function Excluded: (1) onset of stroke to randomisation, 1 to 6 months, (2) cross‐over study, no access to data on the first phase |
| Terre 2012 | Randomised, alternating, cross‐over study assessing effectiveness of chin‐down posture in preventing aspiration in participants with neurogenic dysphagia secondary to acquired brain injury Outcomes: aspiration prevention Excluded: (1) pseudo‐randomised study, (2) assessment of posture |
| Toyama 2014 | Non‐randomised interventional study comparing NMES and conventional treatment vs conventional treatment only Outcomes: swallow scores (VDS, FOIS), hyoid and laryngeal displacement Excluded: not an RCT ‐ not randomised |
| Ueda 2004 | 21 participants Group 1: functional swallowing training (n = 11) Group 2: oral care (n = 11) in nursing home residents (% stroke unknown) who are tube fed Excluded: (1) < 50% stroke, (2) non‐acute, (3) randomisation unclear |
| Varma 2006 | Group 1: motor control programme (n = 30) Group 2: home exercise programme (n = 30) Randomisation method unclear Excluded: (1) insufficient data, (2) outcome methods unclear |
| Wang 2016 | Randomised interventional trial comparing differences in effects between awn‐like needle at Tiantu (CV 22) and filiform needle for dysphagia after cerebral infarction Outcomes: standard swallowing assessment scale and modified Bathel index Exlcuded: confounded ‐ comparing 2 different treatment groups |
| Xia 2016 | RCT with 130 participants with post‐stroke dysphagia In treatment group, acupuncture based on meridian differentiation was adopted. The main acupoints were Neiguan (PC 6), Shuigou (GV 26), Sanyinjiao (SP 6), Fengchi (GB 20), Lianquan (CV 23), Jialianquan (Extra), Jinjin (EX‐HN 12), Yuye (EX‐HN 13), etc. Control group: points were selected 5 cm lateral to the acupoints used in the observation groups and stimulated with shallow puncture Outcomes: standardised swallowing assessment, VFSS, modified Barthel Index and swallowing‐related quality of life (SWAL‐QOL) Excluded: confounded ‐ comparing 2 treatments |
| Zhang 2011 | RCT comparing different depth of Chonggu (EX‐HN 27) by electroacupuncture in participants with dysphagia after stroke Chonggu (EX‐HN 27) deep insertion group (n = 99) Chonggu (EX‐HN 27) shallow insertion group (n = 94) Traditional acupuncture group (n = 90) Outcomes: Kubota's Water Drinking Test Scale, standard swallowing function scale, and TCM Scale of Dysphagia After Stroke Excluded: no available outcome data |
| Zhang 2018a | RCT comparing effects of electroacupuncture with different frequencies in participants with dysphagia after stroke Low‐frequency (2 Hz) electroacupuncture group vs high‐frequency (100 Hz) electroacupuncture group Outcomes: VFSS, standardised swallowing assessment Excluded: not an RCT ‐ dose‐response study (no control group) |
| Zhang 2018b | Randomised interventional trial to assess clinical improvement of nursing intervention in swallowing dysfunction of elderly stroke participants Conventional nursing service vs nursing interventions (psychological intervention, health education, rehabilitation exercises, diet intervention) Outcomes: dysphagia at end of trial, functional outcomes (GQOL‐74) Excluded: confounded ‐ comparing 2 different treatment groups |
| Zhao 2015 | Randomised trial of participants with stroke and swallowing disorders Group A: normal acupuncture Group B: NMES combined with acupuncture with uniform reinforcing‐reducing manipulation as well as the piercing and blood‐letting method Outcomes: Kubota water test, dysphagia at end of trial Excluded: confounded ‐ comparison between 2 treatment groups |
ACE: angiotensin‐converting enzyme CDM: conventional dysphagia management CXR: chest x‐ray FEES: Fibreoptic Endoscopic Evaluation of Swallowing FIM: Functional Independence Measure FOIS: Functional Oral Intake Scale GQOL‐74: Generic Quality of Life Inventory ICU: intensive care unit IOro®: Orofacial device mRS: modified Rankin Scale NGT: nasogastric tube NIHSS: National Institutes of Health Stroke Scale NMES: neuromuscular electrical stimulation PEG: percutaneous endoscopic gastrostomy RCT: randomised controlled trial rTMS: repetitive transcranial magnetic stimulation SAH: subarachnoid haemorrhage SWAL‐QOL: Swallowing Quality of Life Questionnaire TCM: Traditional Chinese Medicine TMS: transcranial magnetic stimulation VDS: videofluoroscopic dysphagia scale VFSS: videofluoroscopy swallow study