Acquired Brain Injury, Brain Tumor, Stroke, Traumatic Brain Injury
Conditions
Keywords
Cranial Orthosis, 3D Printing, Decompression Craniectomy, Retrospective Study, Head Protection Device, Monitored Protocol, Unmonitored Protocol
Brief 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.
Detailed description
The study aims to: 1. Evaluate the feasibility, safety and clinical outcomes of a 3D-printed externally applied cranial orthosis (PEACO) in a clinical setting (unmonitored protocol) 2. Comparison of device A - 2021 Head Protection Prototype Device (HPPD) (DSRB 2019/00155)-monitored protocol with device B (PEACO).
Interventions
None listed
Sponsors
Tan Tock Seng Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-emergent adverse events (safety and tolerability) | 30 minutes post fitting (version 1 and 2) | The therapist will assess patient in terms of pain, redness, skin imprints and pruritus' on patient's skin after wearing the cranial cap. This is to allow the understanding of the incidence of the treatment-emergent adverse events (safety and tolerability). |
| Patient Reported Outcome Measures (PROMS) PROMs (compliance) | 2023-2025 | The patient will be sent a questionnaire. The question relating to compliance is Approximately, how many hours of wear per day including rest breaks? This will allow team to assess feasibility, safety and clinical outcomes. |
| Patient Reported Outcome Measures (PROMS) PROMs (wearing time) | 2023-2025 | The patient will be sent a questionnaire. The question relating to wearing time is Approximately, how many hours of wear per day including rest breaks? This will allow team to assess feasibility, safety and clinical outcomes. |
| Patient Reported Outcome Measures (PROMS) PROMs (adverse events) | 2023-2025 | The patient will be sent a questionnaire. The question relating to adverse event is Did you experience any of the following after two hours of wear? This will allow team to assess feasibility, safety and clinical outcomes. |
| Patient Reported Outcome Measures (PROMS) PROMs (cosmesis rating) | 2023-2025 | The patient will be sent a questionnaire. The question relating to cosmesis rating is Please rate the appearance of your cranial cap. This will allow team to assess feasibility, safety and clinical outcomes. |
Countries
Singapore
Outcome results
None listed