Pittaccio 2013.

Methods	Randomised cross‐over trial. Setting: Italy (at the Istituro Eugenio Media). Funding: Fondazione Cariplo (Philanthropic organisation).
Participants	Total participants: 25 overall study, including 16 with TBI (72% male in overall study). Overall participants (TBI not reported separately): age: 7.75 years (SD 5.40, range 4‐19). However, the review author team calculated this (using the individual participant ages provided in the paper and, which resulted in a mean age of 9.08 years (SD 5.38)). Adults: 0, children: 16. Inclusion criteria: acquired quadriplegia or hemiplegia; aged 4‐18 years; Ashworth Score for the target limb > 1. Exclusion criteria: pathologies of the target joint or skin affections in the target area. Location of spasticity: upper limb: elbow (flexors); lower limb: ankle (extensors).
Interventions	Pseudoelastic orthosis: spring‐loaded orthosis comprised of 2 parts that could rotate relative to one another around a common axis. Each orthosis was individually customised and worn for 1 month. Traditional static splint: no further details provided about the splint, other than it was worn for 1 month. Washout period: no washout period as study authors considered it unethical to leave participants without any treatment.
Outcomes	Outcome assessed at: baseline, and 1 (at cross‐over) and 2 months (end of second treatment). Unclear which were primary and secondary outcomes range of motion; spasticity: Modified Ashworth Scale. Length of follow‐up: 2 months.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No detail on method of randomisation reported.
Allocation concealment (selection bias)	Unclear risk	No details on method of allocation concealment (if any).
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding within this study was impossible due to the nature of the 2 active treatments (traditional splints appear very different to the experimental 'pseudoelastic' ones).
Blinding of outcome assessment (detection bias) All outcomes	High risk	See above. In addition, no attempts to blind outcome assessors or data analysts to the treatment status of participants was reported.
Incomplete outcome data (attrition bias)	Low risk	Appeared that all participants completed treatment as intended and that there were no missing data.
Selective reporting (reporting bias)	High risk	No published protocol. Furthermore, there was a pronounced tendency in the paper to report perceived benefits in detail (e.g. data regarding rigidity outcomes for ankles in particular) whilst few details and no numerical data were provided for results wherein no difference between treated groups was apparent (e.g. for spasticity as measured by the Modified Ashworth Scale) despite these being collected after both treatment phases as well as at baseline. Whilst this does not indicate 'suppression' of data, it obviates meta‐analyses (should comparable trials be identified).
Baseline Imbalances	Low risk	Baseline imbalances not clear but not relevant for a cross‐over trial.
Appropriate study design (cross‐over trial only)	Low risk	A cross‐over study design was reasonable due to a small sample size.
Adequate washout period (cross‐over trial only)	Low risk	Investigators considered it unethical to have a washout period; investigators also went to lengths to confirm that the sequential order of treatments did not make any difference to the final outcome (p = 0.30, T2‐T0, TP vs PT, paired 2‐tailed Student's t test, 23 participants).
Other bias	Unclear risk	Although the inclusion criteria stated that participants had to be aged 4‐18 years and have a score > 1 on the Modified Ashworth Scale, 1 participant was 19 years of age and had a score of 0.