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Trial · NCT07060742

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryFeasibility of the exergame-based motor-cognitive training: adherenceThroughout the 4-week intervention period.
The adherence protocol measures the percentage of training sessions attended by participants relative to the number of planned sessions. It reflects how consistently participants follow the prescribed training schedule. Adherence is calculated by dividing the attended sessions by the planned sessions and expressing the result as a percentage. High adherence rates suggest that the intervention is feasible for older psychotic inpatients.
PrimaryFeasibility of the exergame-based motor-cognitive training: attritionTime Frame: Throughout the 4-week intervention period
Attrition: Drop-Out Rates. This refers to the percentage of participants who discontinue or leave the study before its completion. Drop-out rates are calculated by dividing the number of participants who withdraw by the total number initially enrolled, usually expressed as a percentage. High dropout rates may indicate issues with the intervention's feasibility.
PrimaryFeasibility of the exergame-based motor-cognitive training: safetyTime Frame: Throughout the 4-week intervention period
Safety, measured through the reporting of adverse events, assesses the occurrence and nature of any negative or unintended effects experienced by participants during the study. These events are systematically recorded, including their type, severity, timing, and potential relation to the intervention. No adverse events indicate that the intervention is safe and feasible.
SecondaryCognitive function: inhibitory controlThroughout the 4-week intervention period
Stroop Color and Word Test (Senso-based): This test measures inhibitory control. Participants are shown words that name colors (e.g., "blue", "red") printed in incongruent ink colors (e.g., the word "blue" printed in red ink). They must name the color of the ink, not read the word, requiring them to suppress the automatic reading response. Reaction time (in milliseconds) and accuracy are recorded. Lower reaction times and fewer errors indicate better executive functioning.
SecondaryCognitive function: processing speedTime Frame: Throughout the 4-week intervention period
Reaction Time Test (RTT, Senso-based): This test measures basic processing speed. Participants are presented with simple visual stimuli on a screen (e.g., a light or symbol) and must respond as quickly as possible by pressing a button or stepping onto a platform. The test records reaction time in milliseconds and the number of errors (e.g., missed or premature responses). Shorter reaction times and fewer errors indicate better cognitive and motor responsiveness.
SecondaryCognitive function: selective attentionTime Frame: Throughout the 4-week intervention period
Arrow Test (Senso-based): This test assesses inhibitory control. It consists of two phases: * In the first phase, participants stand on a central platform and must step toward the side where an arrow appears on the screen, reacting as quickly as possible. * In the second phase, participants must step in the direction the arrow points, regardless of its position on the screen (e.g., an arrow may appear on the left but point to the right), requiring greater cognitive control to inhibit automatic responses. Reaction time (ms) and number of errors are recorded. Lower reaction times and fewer errors indicate better performance.
SecondaryCognitive function: inhibitory controlTime Frame: Throughout the 4-week intervention period
The Go-NoGo Test (Senso-based) primarily measures inhibitory control. Participants focus on a central gray dot while an "x" or "+" appears to the left or right. When an "x" appears, they must quickly step toward its location; when a "+" appears, they must withhold any response. Reaction time (in milliseconds) and accuracy-both correct responses to "x" and successful inhibitions to "+"-are recorded. Lower reaction times and higher accuracy indicate better cognitive control and response inhibition.
SecondaryMotor function: mobilityTime Frame: Throughout the 4-week intervention period
The Timed Up and Go Test (TUG) measures functional mobility. Participants start seated in a chair, then stand up, walk a short distance (usually 3 meters), turn around, walk back, and sit down again. The time taken to complete this sequence is recorded in seconds. The test is performed under both single-task (just walking) and dual-task conditions (walking while performing a cognitive or motor task). Shorter times indicate better mobility, balance, and ability to perform everyday movements safely and efficiently.
SecondaryMotor function: gait speedTime Frame: Throughout the 4-week intervention period
The 10-Meter Walk Test measures gait speed. Participants are asked to walk a 10-meter distance twice: once at their normal, comfortable pace, and once at an accelerated, faster pace. The time taken to complete each walk is recorded in seconds, and gait speed is calculated by dividing distance by time. Higher gait speeds indicate better walking performance, mobility, and functional capacity.
SecondaryMotor function: balanceTime Frame: Throughout the 4-week intervention period
The Coordinated Stability Test (Senso-based) measures balance coordination. Participants stand still and adjust their body by bending or rotating-without moving their feet-to keep a cursor or marker within a designated track displayed on the screen. The test records metrics such as completeness and stability (where higher values indicate better control), as well as path length, duration, and reverse movements (where lower values indicate better performance). This assesses the ability to maintain balance and make fine motor adjustments to remain stable.
SecondaryMotor function: physical activityTime Frame: Throughout the 4-week intervention period
The accelerometers ActiGraph GT3X+ and Axivity AX3 measure physical activity levels by continuously recording tri-axial acceleration data over a 48-hour period. Worn on the body, these devices capture movement intensity and frequency. The raw acceleration data are processed and classified into different activity intensity categories-such as sedentary, light, moderate, and vigorous-based on predefined thresholds. Higher activity counts indicate more intense or frequent movement, while lower counts reflect periods of inactivity or sedentary behavior. This allows objective assessment of overall physical activity patterns and sedentary time.
SecondaryPsychotic symptoms: patient's response to treatmentTime Frame: Throughout the 4-week intervention period
The Clinical Global Impression of Change (CGI) measures overall symptom severity and the patient's response to treatment, as rated by a clinician. Using standardized scales, the clinician assesses how much the patient's condition has improved or worsened compared to baseline. Lower scores indicate fewer symptoms and better treatment response, while higher scores reflect more severe symptoms or less improvement. This tool provides a quick, global evaluation of clinical status and treatment effectiveness. The Severity of Illness scale includes: Not assessable; Not ill at all; Borderline psychiatric case; Mildly ill; Moderately ill; Markedly ill; Severely ill; Extremely severely ill.The Global Improvement scale includes: Not assessable; Very much improved; Much improved; Slightly improved; No change; Slightly worse; Much worse; Very much worse
SecondaryPsychotic symptoms: severity of psychotic symptomsTime Frame: Throughout the 4-week intervention period
The Positive and Negative Syndrome Scale (PANSS) measures the severity of psychotic symptoms across three domains: positive symptoms (e.g., hallucinations, delusions), negative symptoms (e.g., social withdrawal, lack of motivation), and general psychopathology (e.g., anxiety, depression). A clinician rates each of the 30 items on a standardized scale from 1 to 7, where 1 = Absent, 2 = Minimal, 3 = Mild, 4 = Moderate, 5 = Moderately severe, 6 = Severe, and 7 = Extreme. Scores are summed to produce total and subscale scores. Higher scores indicate more severe symptoms, while lower scores reflect milder symptom severity. The PANSS is widely used to assess and monitor the clinical status of patients with psychotic disorders.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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