Gisel 1996b.
| Methods | Randomised controlled trial | |
| Participants | 35 children (19 males) aged 4 years 3 months to 13 years 3 months across 3 groups (A, B, C) A: 11 participants, 5 males; X = 6 years 3 months, SD = 1.4 years B: 12 participants, 8 males; X = 7 years 3 months, SD = 2.1 years C: 12 participants, 6 males; X = 7 years 7 months SD = 2.7 years All children had a diagnosis of cerebral palsy with moderate to severe motor impairment Children's weight was at 5th percentile for age and at or below the 35th percentile for skin‐fold measures (triceps and subscapular) 27 children were wheelchair‐bound, 5 were ambulatory, 3 used tricycles for ambulation All children needed assistance with activities of daily living, including eating, and had a range of hypotonicity and hypertonicity in their trunk and extremities |
|
| Interventions | A: sensorimotor treatment for 20 weeks Involved 5‐7 minutes daily, 5 days per week, prior to lunch. Emphasis placed on tongue lateralisation, lip control and vigour of chewing (exact protocol detailed in the manuscript). All treatment conducted with small food stimuli B: chewing only treatment for 20 weeks Involved 5‐7 minutes daily, 5 days per week, prior to lunch. Children were offered small pieces of fruit gelatin of medium to hard viscosity. Number of pieces varied depending on child's chewing ability. Children given harder textures (i.e. firm cereal bits of pieces of hard biscuits) as they progressed C: control group who followed the school feeding routine for 10 weeks (control) and then received 10 weeks of sensorimotor treatment as for A |
|
| Outcomes | Outcome assessments conducted at 3 time points: the onset of the study (0 weeks), at 10 weeks, and at 20 weeks. Outcome measures included:
No statistically significant differences between groups from baseline (week 0) to weeks 10 or 20 on measures of eating time, clearing time (after swallows) or duration of mealtime. There were no significant differences found for any group on the ability to advance to a more solid texture from baseline to weeks 10 or 20 Participants maintained their weight‐for‐age percentile, at the lower end of expected norms |
|
| Notes | One child in group A died owing to causes unrelated to the study. Authors reported that it was not possible to recruit another child because the death occurred past the mid‐point of the study. Difficult to interpret findings because the control group received no treatment up until week 10 only, and then received the oral sensorimotor treatment as for experimental group A. As such, comparisons can only be made between experimental versus control groups up to week 10 of the intervention. 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) | Low risk | Random numbers table used |
| Allocation concealment (selection bias) | Low risk | Random assignment occurred after informed consent was obtained |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | The nature of the treatment conditions resulted in neither participant or personnel being blinded |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessor blinded throughout the study |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Only one child was unable to complete the treatment and final outcome assessment (she died for reasons external to the study). Treatment compliance was reported (average of 78.6 ± 2.1%) and was not statistically significantly different between the 3 groups. No mention made of whether any children missed any outcome assessments |
| Selective reporting (reporting bias) | Low risk | Average group data was reported on all outcome measures |
| Other bias | Unclear risk | No obvious further sources of bias |