Tablet-based Application for Cognitive Therapy

NCT06462703 | Recruiting

• 1 other identifier: TACTIC
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in CERAD-plus scores

  From enrolment to the end of treatment at 12 weeks

Secondary Outcomes (4)

• Mean change from baseline in BIAS-R scores

  From enrolment to the end of treatment at 12 weeks

• Mean change from baseline in CETI score

  From enrolment to the end of treatment at 12 weeks

• Mean change from baseline in HADS-D scores

  From enrolment to the end of treatment at 12 weeks

• Mean change from baseline in EQ-5D-5L scores

  From enrolment to the end of treatment at 12 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

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)

Device: Tablet-based neurorehabilitation with myReha

Control Group

NO INTERVENTION

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

Interventions

Tablet-based neurorehabilitation with myReha 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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Serious disabling disease(s) which, in the opinion of the investigator, would preclude participation in the study until the follow-up phase
• Pregnancy

Sponsors & Collaborators

• Klinikum Floridsdorf: lead

Study Sites (1)

Klinik Floridsdorf

Vienna, 1210, Austria

RECRUITING

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 17, 2024
• Study Start: March 2, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)