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The objective of this study is to develop new digital solutions for patients with prolonged postconcussion symptoms, and investigate its usability, feasibility, and safety. The digital solutions consist of a 1) symptom mapping and clinical decision support system, and 2) a research-based system for home-based biofeedback treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital symptom mapping and biofeedback treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital symptom mapping and biofeedback treatment | Device | Digital symptom mapping and biofeedback treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Usability of new digital solutions for symptom mapping and home-based biofeedback treatment in patients with PPCS/PTH | - Description mHealth App Usability Questionnaire scores in the target user group; and Mobile App Rating Scale scores by an independent group of clinicians and researchers | Will be assessed at three different time points: After each usability testing during the iterative development cycles (T1 and T2) and after the home-testing period (T3). |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility and adherence of new digital solutions |
| Will be assessed after the home-testing period (T3) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of new digital solutions | Description of the frequency and severity of adverse events, serious adverse events and unexpected serious adverse events | Will be assessed at three different time points: After each usability testing during the iterative development cycles (T1 and T2) and after the home-testing period (T3). |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Olavs Hospital | Trondheim | Norway |
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| ID | Term |
|---|---|
| D038223 | Post-Concussion Syndrome |
| D051298 | Post-Traumatic Headache |
| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D016489 | Head Injuries, Closed |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
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| D009422 |
| Nervous System Diseases |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |