Active — Not RecruitingNot Applicable

Feasibility and Outcomes of 3D-printed External Cranial Orthosis After Craniectomy

Singapore32 participantsStarted 2025-07-29

Plain-language summary

This study will compare the outcomes of a current clinical implementation of PEACO designed for one-handed donning and doffing with carer-monitoring with a previous prototype (HPPD) requiring carer-donning and doffing with therapist monitoring.

Who can participate

Age range21 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Unilateral decompressive craniectomy (DC) * Acute Stroke or traumatic brain injury * \>30 days post DC * Healed surgical wounds, non-bulging flaps * Presence of caregiver supervision Exclusion Criteria: * Vegetative or minimally responsive state * Uncontrolled medical illnesses, e.g. sepsis, delirium, active malignancy * Life expectancy \< 6 months * Unhealed or infected post-DC neurosurgical wounds * Known allergy to investigational products

What they're measuring

Treatment-emergent adverse events (safety and tolerability)

Timeframe: 30 minutes post fitting (version 1 and 2)

Patient Reported Outcome Measures (PROMS) PROMs (compliance)

Timeframe: 2023-2025

Patient Reported Outcome Measures (PROMS) PROMs (wearing time)

Timeframe: 2023-2025

Patient Reported Outcome Measures (PROMS) PROMs (adverse events)

Timeframe: 2023-2025

Patient Reported Outcome Measures (PROMS) PROMs (cosmesis rating)

Timeframe: 2023-2025

Trial details

NCT IDNCT07122752

SponsorTan Tock Seng Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-08-29

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