NCT06462703 Tablet-based Application for Cognitive Therapy
| NCT ID | NCT06462703 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Klinikum Floridsdorf |
| Condition | Brain Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-03-02 |
| Primary Completion | 2025-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2023-03-02 with a primary completion date of 2025-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Cognitive impairments such as deficits in attention, executive functions, perception, language, speech, arithmetics, and memory are very common symptoms after acquired brain injury, which can be caused by neurological diseases such as stroke, cerebral haemorrhage or traumatic brain injury. Around 83% of patients with brain injury suffer from a sequelae of cognitive impairments. Since the effects caused by neurological diseases can vary greatly from person to person, intensive and individual neuro-rehabilitation is necessary to help patients return to an independent life in the best possible way. In the DACH area (i.e., in Germany, Austria, and Switzerland), patients with cognitive impairments following brain injuries generally receive this intensive and interdisciplinary treatment while being hospitalised in an inpatient clinic following acute medical care. However, once they leave inpatient care facilities, there are insufficient treatment options readily available to them due to limitations/shortages in the healthcare system's resources, although studies indicate that an increase in therapy time (both in outpatient settings at home or in care facilities) enables greater, long-term rehabilitation progress and faster reintegration and participation in everyday life. Thanks to recent technical advancements, digital treatment options now promise the availability of sufficiently frequent and intensive treatment outside of clinic settings. In that context, the myReha therapy software (available as an app on iOS ad Android tablets), a certified medical device, was developed to enable patients to receive individualised and intensive therapy regardless of the healthcare system's constraints. To test the effectiveness of the myReha therapy software, in this two-arm, randomised, controlled study, patients in the intervention group receive treatment through the myReha therapy software in addition to their usual standard care (i.e., care-as-usual - CAU), while the control group only receives CAU. Treatment outcomes (i.e., rehabilitation progress) are measured based on the CERAD-plus.
Eligibility Criteria
Inclusion Criteria: * Cognitive impairment (deficits in attention, arithmetics, executive functions, memory, language, perception) according to CERAD-plus after a diagnosed brain injury ≥ 4 weeks ago * No prior experience with a therapy app for neurological deficits * Motivation to use the therapy software regularly * Sufficiently good German language skills prior to the brain injury Exclusion Criteria: * Being unable to use a tablet without assistance * Severe visual or hearing impairment that interferes with the performance on psychometric testing procedures * Any pre-existing speech or language disorder or dementia prior to the onset of brain injury * An ongoing outpatient or inpatient rehabilitation at the time of study inclusion or planned rehabilitation of the primary disease during the study period * Serious disabling disease(s) which, in the opinion of the investigator, would preclude participation in the study until the follow-up phase * Pregnancy
Frequently Asked Questions
Who can join the NCT06462703 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Brain Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06462703 currently recruiting?
Yes, NCT06462703 is actively recruiting participants. Visit ClinicalTrials.gov or contact Klinikum Floridsdorf to inquire about joining.
Where is the NCT06462703 trial being conducted?
This trial is being conducted at Vienna, Austria.
Who is sponsoring the NCT06462703 clinical trial?
NCT06462703 is sponsored by Klinikum Floridsdorf. The trial plans to enroll 200 participants.