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Efficacy of a Rhythm-based Serious Game for Improving Executive Functions in Individuals with Neurocognitive Deficits: a Randomized Controlled Trial

Efficacy of a Rhythm-based Serious Game for Improving Executive Functions in Individuals with Neurocognitive Deficits: a Randomized Controlled Trial - RHYTHMWO

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00035941
Enrollment
66
Registered
2025-01-22
Start date
2025-02-10
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Individuals with an acquired brain injury and a structural deficit (confirmed by MRI or CT) and cognitive deficits in executive functions or attention (objectifiable or subjectively reported)

Interventions

Group 1: Intervention group (IG): independent home training using the "Rhythm Workers" app (Bégel et al., 2018) for 4 weeks. Participants are required to train five times a week for 20-30 minutes each

Sponsors

Tagesklinik für Kognitive Neurologie, Universitätsklinikum Leipzig
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) acquired brain injury with a structural deficit (confirmed by MRI or CT), (2) an elapsed time since injury of at least three month, (3) cognitive deficits in executive functions or attention (objectifiable or subjectively reported), (4) willingness and ability to participate, and (5) complete informed consent form.

Exclusion criteria

Exclusion criteria: (1) motor, hearing, or comprehension deficits that do not allow participation, (2) severe psychiatric disorder, (3) alcohol / drug abuse, (4) evidence for media addiction, (5) professional musicians, (6) pregnancy or planned pregnancy, breastfeeding women, (7) intensive neuropsychological therapy over the last three months (i.e. inpatient or day-clinic). Continuation of outpatient treatment will be registered.

Design outcomes

Primary

MeasureTime frame
The following measures are assessed at pre-, post-intervention, and three-month-follow-up: Executive functions: - For cognitive flexibility, we use the Trail Making Test (TMT) (Reitan, 1992) in a modified paper-pencil version according to Rodewald et al. (2012). Using the absolute processing times, an index is calculated according to the formula [(B - A)/A] (Periáñez et al., 2007). - For executive control, we use the Attentional Network Task (ANT) (Fan et al., 2002) and calculate a proportional score for the conflict effect [(RTincongruent – RTcongruent)/ RTcongruent] (Treffers-Daller et al., 2020; Urbanek et al., 2010). - For inhibitory control, we use a Simon task implemented as the incompatibility test of the software package Test of Attentional Performance (TAP) (Zimmermann & Fimm, 2014). A proportional score is calculated according to the formula [(RTincompatible - RTcompatible)/ RTcompatible]. - For working memory, we use the digit and block span backwards tasks (sum score) from the Wechsler Memory Scale (WMS-R; German Version) (Härting et al., 2000). Rhythmic abilities: We use the Battery for the Assessment of Auditory Sensorimotor and Timing Abilities (BAASTA) (Dalla Bella et al., 2017 & 2024). The following subtasks will be used: - For beat perception, we use the Beat Alignment Test (d prime) - For synchronization consistency, we use paced tapping to metronome and to music (Vector length) - For rhythmic-motor variability, we use synchronization-continuation task (CV of the ITI)

Secondary

MeasureTime frame
- Compliance with the protocol refers to the degree to which participants fulfill the requested protocol targets. We assess this by comparing the required training duration with the cumulative training duration (i.e., of training sessions; self-reported and logged on the device) and continuous playing time (CPT) in minutes (i.e., time spent in active gameplay in game levels; logged on the device). - Game acceptance refers to the degree to which participants felt engaged when playing the game. We measure game acceptance by the level of enjoyment and frustration assessed after a gaming session. - Treatment satisfaction: At the post-treatment assessment, all participants are asked for a ranking on a 5-point Likert Scale on 4 items: (1) How comfortable do you feel about completing the tasks at home? (2) How comfortable do you feel about completing the tasks on the tablet? (3) Would recommend the Rhythm Workers app to a friend? (4) How satis?ed are you with the results of the treatment? - Subjective rating of "relevant domains" is assessed with a self-constructed questionnaire covering the areas of concentration, mental deceleration, executive functions, energy level, well-being, and quality of life. Participants are asked to rank the items on a 5-point Likert scale at pre-, post-test, and three-month-follow-up. Mean scores are calculated.

Countries

Germany

Contacts

Public ContactAlina S. Löser

Tagesklinik für Kognitive Neurologie, Universitätsklinikum Leipzig

loeser@cbs.mpg.de+49 341 97 24981

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026