PTPilotProsthetics and orthotics international2024

Safety, walking ability, and satisfaction outcomes of the NEURO TRONIC stance-control knee-ankle-foot orthosis (SCKAFO): A comparative evaluation to the E-MAG active SCKAFO.

Bart Raijmakers, Merel Anne Brehm, Frans Nollet and 1 others

PMID 38019018

WHAT IT FOUND

The primary knee-joint safety outcome did not differ significantly between NEURO TRONIC and E-MAG stance-control knee-ankle-foot orthoses in adults with neuromuscular knee weakness.

Perceived walking effort favoured NEURO, but this small uncontrolled study cannot prove superiority.

Key findings

01The primary knee-joint safety outcome was not significantly different: no locking failures occurred with either orthosis, and unlocking failures were 9.3% of steps with the NEURO TRONIC orthosis versus 13.9% with the E-MAG orthosis (p=0.406).

02Net energy cost was 3.38 J/kg per meter with the NEURO TRONIC orthosis versus 3.68 J/kg per meter with the E-MAG orthosis, a difference of 0.30 J/kg per meter that was not significant (p=0.123).

03Perceived walking effort improved with the NEURO TRONIC orthosis (median 4.0 versus 3.0, p=0.014).

STILL TO COME

How it was doneWhat they foundWhat it means for PTs

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What it does not show

Only 9 adults were analysed, so the study was too small to detect real differences in energy cost or knee safety. The study was uncontrolled and participants all switched from their existing E-MAG Active orthosis to a NEURO TRONIC orthosis, so time, learning and fitting effects cannot be separated. Participants were already satisfied E-MAG Active users, so results may not apply to patients unhappy with their current orthosis. The treadmill tests did not produce locking failures, possibly because they were not challenging enough or because users were skilled, so daily-life fall safety remains unclear. Reported falls were self-reported and the study did not record fall circumstances, so the lower falls count cannot be linked to the orthosis. Gait analysis was completed on 8 of 9 subjects. The devices are expensive, so they may not be available everywhere.

Declared interests

Fior & Gentz, the manufacturer of the NEURO TRONIC knee joint, and OIM Orthopedie, which manufactured the study orthoses, funded the work and supplied devices. They had no role in collecting, analysing or interpreting data, but they reviewed the manuscript for proprietary information and discussed how to adapt the publication.

The easy way to misread this

Do not read the lower reported falls (median 0.0 versus 1.0 falls per year) as proof that the NEURO TRONIC orthosis prevents falls. This was a secondary self-report outcome, fall circumstances were not recorded, and perceived effectiveness for number of falls did not differ; the primary knee-safety outcome was null.

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