Tablet-based Application for Cognitive Therapy

NCT ID: NCT06462703

Last Updated: 2024-06-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-02
• Study Completion Date: 2025-06-01

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.

Conditions

Brain Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: EXPERIMENTAL

Tablet-based neurorehabilitation with myReha

Intervention Type: DEVICE

The myReha therapy software provides cognitive therapy in the domains attention, executive functions, perception, language, speech, arithmetics, and memory. It automatically creates weekly plans that are individually tailored to a patient's abilities and provides real-time feedback when completing tasks. Intelligent algorithms ensure that the exercises always remain at the optimum level of difficulty.

Control Group

Patients allocated to the control group only receive usual standard care (CAU).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Tablet-based neurorehabilitation with myReha

The myReha therapy software provides cognitive therapy in the domains attention, executive functions, perception, language, speech, arithmetics, and memory. It automatically creates weekly plans that are individually tailored to a patient's abilities and provides real-time feedback when completing tasks. Intelligent algorithms ensure that the exercises always remain at the optimum level of difficulty.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Klinikum Floridsdorf

OTHER

Sponsor Role: lead

Responsible Party

Peter Lackner

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Klinik Floridsdorf

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Facility Contacts

Peter Lackner, Prof., MD

Role: primary

peter.lackner@gesundheitsverbund.at

+43 1 27700 ext. 2008

Other Identifiers

TACTIC

Identifier Type: -

Identifier Source: org_study_id