Summary of findings 3. Pseudoelastic orthosis versus traditional (static) splint for spasticity in people with traumatic brain injury.

Pseudoelastic orthosis versus traditional (static) splint for spasticity in people with traumatic brain injury
Patient or population: children/young people aged 4‐18 years with traumatic brain injury and with 'mild to severe spastic tetraparesis' (weakness) in all limbs Settings: Istituro Eugenio Media (Italy) Intervention: repositioning splints equipped with participant‐specific pseudoelastic hinges Comparison: traditional splints with fixed angle braces
Outcomes	Results and conclusions	No of participants (studies)	Quality of the evidence (GRADE)
Spasticity at up to 6 hours after treatment (measured by the Modified Ashworth Scale, 0‐4, with a higher score indicating greater spasticity)	We are uncertain about the effect of pseudoelastic splints compared with traditional splints on spasticity.1	25 (1)	⊕⊝⊝⊝ Very low2
Adverse events	We are uncertain about the effect of pseudoelastic splints compared with traditional splints on adverse events.3	25 (1)	⊕⊝⊝⊝ Very low4
Sensory functions and pain	The included study did not report this outcome.
Neuromusculoskeletal and movement‐related functions post treatment (measured by range of movement)	We are uncertain about the effect of pseudoelastic splints compared with traditional splints on range of movement.5	25 (1)	⊕⊝⊝⊝ Very low6
General tasks and demands	The included study did not report this outcome.
Mobility	The included study did not report this outcome.
Self‐care	The included study did not report this outcome.
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.

¹One study comparing novel pseudoelastic orthoses to traditional fixed angle splints reported no improvement in spasticity in the upper and lower limbs, over a period of one month of intervention. and that results of the two steps were not significantly different (Pittaccio 2013).

²Downgraded four times due to risk of bias limitations (study provided no information about sequence generation and allocation concealment; blinding was impossible for participants or personnel and not reported for outcome assessors; selective outcome reporting bias was high); our concerns about indirectness of the Ashworth Score and indirectness due to 36% of participants not having traumatic brain injury and one participant was of dubious eligibility; an inability to assess imprecision relating to an absence of meaningful outcome data (no numerical data were provided for spasticity; investigators reported only that there were no significant differences), and there was only one study for this comparison/outcome and that publication bias was possible in this area.

³No adverse events were reported for pseudoelastic orthoses neither did any require adjustments after fitting. Adjustments were required for 30% of traditional splints to reduce skin rash, haematomas and oedema.

⁴Downgraded four times due to risk of bias limitations (study provided insufficient information about sequence generation and allocation concealment, blinding was impossible for participants and personnel and not reported for outcome assessors, and selective reporting bias was high). We had concerns about indirectness given that 36% of participants did not have traumatic brain injury and one participant was of dubious eligibility. Furthermore, there was only one study for this comparison/outcome and publication bias was possible in this area.

⁵One study reported no improvement in range of movement in the upper and lower limbs, over a period of one month of intervention (Pittaccio 2013).

⁶Downgraded five times due to risk of bias limitations (this study provided insufficient information about sequence generation and allocation concealment, blinding was impossible for participants and personnel and not reported for outcome assessors, and selective reporting bias was high). We had concerns about indirectness due to 36% of participants not having traumatic brain injury and one participant was of dubious eligibility; our inability to assess imprecision given that means and standard deviations were only presented within a small box and whiskers plot, and a further downgrade for there only being one study for this comparison/outcome and the likelihood of publication bias in this area.