Tablet-based Application for Cognitive Therapy In the Care of Brain Injury

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Austria
Klinik Floridsdorf
RECRUITING
Vienna
Time Frame
Start Date: 2023-03-02
Estimated Completion Date: 2025-06-01
Participants
Target number of participants: 200
Treatments
Experimental: Intervention Group
Patients allocated to the intervention group receive treatment through the myReha therapy software in addition to their usual standard care (i.e., care-as-usual; CAU)
No_intervention: Control Group
Patients allocated to the control group only receive usual standard care (CAU).
Related Therapeutic Areas
Sponsors
Leads: Klinikum Floridsdorf

This content was sourced from clinicaltrials.gov