Ottenbacher 1981.

Methods	Randomised controlled trial
Participants	20 participants (aged 5 to 21.6 years, 12 males) with severe or profound ID who were residents in a state‐supported institution for people with ID. All participants had some degree of neuromotor disorder, with 18 participants having a diagnosis of cerebral palsy (11 spastic quadriplegic, 2 athetoid, 5 mixed). All dependent on most areas of self‐care, including needing assistance in feeding, and had some degree of oral‐motor pathology 10 participants randomly selected to take part in oral‐motor therapy and 10 participants served as a control group The control group received their regular programme of therapy and education with no specific treatment of oral‐motor dysfunction or feeding. As for the experimental children, the control children received their regular diet and were fed by their regular aides
Interventions	Each participant received approximately 30 to 40 minutes of therapy daily, 5 days a week for 9 weeks. Some participants received therapy just prior to or in conjunction with their meals, and others were scheduled for therapy at various times during the day. The treating therapist would determine which children received therapy during or just before mealtimes based on the nature of the oral‐motor/feeding problem exhibited by the participant. There were 3 major components to the treatment: inhibition of abnormal oral and postural reflexes facilitation of normal muscle tone desensitisation of the oral region The exact treatment programme for each participant was developed based on the initial oral‐motor evaluation and an observation of the individual subject's feeding pattern. Specific treatment techniques were drawn from those proposed by Gallander 1979; Gallander 1980. All therapy was administered on an individual basis by 2 occupational therapists experienced in paediatric treatment
Outcomes	Outcome assessments were conducted pre‐ and post‐therapy. Outcome measures included: evaluation of oral‐motor and feeding function Part I: rating function on a 4‐point ordinal scale (where a score of 4 indicated the most normal or independent performance) for: 4 oral reflexes, the position of the tongue at rest, and the degree of drooling. Total possible score of 24 Part II: 21 items taken from the 47 total feeding behaviour items in the Vulpe Assessment Battery (Vulpe 1977). The 21 items were chosen because they covered lower level feeding behaviour appropriate to the participants under investigation. Total possible score of 84 weight Post‐therapy oral‐motor evaluations of 9/10 children in the experimental group revealed no significant change in oral‐motor function (t = 1.09; P > 0.1; df = 16). Because post‐therapy evaluations were only available for 2/10 of the control group, no pre‐ and post‐therapy comparison was possible. No statistically significant change in weight post‐therapy for either group (after adjustments were made for differences in pre‐therapy weights). Some individual participants in the experimental group (n = 6) evidenced weight gains over the treatment period, but 3 evidenced weight loss. Similarly in the control group, 5 evidenced weight gains and 3 evidenced weight loss
Notes	Potential for a high degree of variability in the treatment administered. Difficult to replicate this study owing to lack of detail on treatment protocol. Further, this study is at risk of selection bias given the very small sample size of participants per group
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomisation process not described
Allocation concealment (selection bias)	Unclear risk	Allocation concealment not specified
Blinding of participants and personnel (performance bias) All outcomes	High risk	The nature of the treatment resulted in neither participant nor personnel being blinded
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No mention of whether the outcome assessors were blinded
Incomplete outcome data (attrition bias) All outcomes	High risk	Owing to staffing changes at the institution where the study took place, not all participants were able to be administered post‐therapy oral motor evaluations. Post‐therapy evaluations were conducted with 9 participants in the treatment group and 2 in the control
Selective reporting (reporting bias)	Low risk	Data were reported for all outcome measures where available (and missing data were specified as above)
Other bias	High risk	Significant difference in weight between the treatment and control groups at baseline (participants in the control group had a higher average weight). Difficult to determine whether experimental and control groups were similar on other characteristics at baseline as little information provided