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To design and create wearable head protection to be worn on a patient's head following a neurosurgical procedure (namely craniectomy and craniotomy
After being given informed consent, all participants will undergo the fitting and trial of a specially designed head protection for 6 weeks. Week 1 participants will be assessed and clinical data obtained on participants condition with the head protection fitted during the same session. Participants will return after 3 weeks for review and adjustment and again at the 6 week interval where they will also be given a questionnaire to fill up regarding their use and comfort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Head protection | Experimental | Participants are given a form of head protection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Head protection device | Device | The participants are fitted with a form of head protection over the craniectomy and provide feedback on design, use, and comfort |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction Survey | A survey to assess Satisfaction with device | 6 weeks after receiving their head protection fitting |
| Measure | Description | Time Frame |
|---|---|---|
| Euro Quality of Life - 5 Dimensions (EQ-5D) | Quality of life survey. The higher the score from 0-5 for each dimension, the higher the quality of life. | 6 weeks after receiving their head protection fitting |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Trevor Binedell | Tan Tock Seng Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tan Tock Seng Hospital | Singapore | 308433 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29291381 | Background | Colasante C, Sanford Z, Castro N, Bartels MN. Custom Fabrication of a 3-Dimensionally Printed Helmet for Improved Socialization and Subjective Self-Assessment in a Case of Acquired Cranial Defect: A Case Presentation. PM R. 2018 Jun;10(6):671-674. doi: 10.1016/j.pmrj.2017.11.005. Epub 2017 Dec 30. | |
| 31602146 | Background |
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Anonymised Information will be published in a journal once completed
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| Lucano LRG, Brambila FJP, Perez JE, Rosales PH. Customized Low-Cost 3D Printed Helmet as a Temporary Measure for a Patient with Acrania. Indian J Plast Surg. 2019 May;52(2):252-253. doi: 10.1055/s-0039-1696077. Epub 2019 Sep 12. No abstract available. |