PsychosisNCT07060742
Study on the Use of Exergames to Support Older Adults With Psychosis
A study testing Dividat Senso and OTAGO Falls-prevention program in people with Psychosis and Exergaming, run by Tobias Melcher at 1 site in Switzerland.
Trial summary
This study aims to explore a new, engaging approach to support older adults with psychosis-an umbrella term that includes conditions such as schizophrenia, late-onset schizophrenia, and psychotic symptoms resulting from other medical or psychiatric conditions like dementia, delirium, mood disorders, or delusional… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Psychosis, Exergaming, Elderly
- What is being tested?
- Dividat Senso and OTAGO Falls-prevention program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Jun 2025to 15 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed psychotic disorders
- Able to provide a signed informed consent
- Age ≥ 55 years
- MoCA ≥ 20
- Physically able to stand for at least 3 minutes without external support (self-report)
Who cannot join
- Insufficient knowledge of the German language to understand the instructions, the games, and the assessments
- Mobility, cognitive, sensory and/or psychiatric limitations or comorbidities that impair the ability to play the exergames and/or conduct the pre-/post assessments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Universitäre Psychiatrischen Kliniken (UPK) Basel
Basel, Canton of Basel-City, 4002
Christoph Linnemann, Dr. med., +41 61 325 5355, christoph.linnemann@upk.ch
Riccardo Bernardi, M.Sc. Science of Psychology, riccardo.bernardi@upk.ch
About this study
Official title: Feasibility of Exergame-based Cognitive-motor Training in Older Psychotic Inpatients: a Randomized Controlled Trial
This study aims to explore a new, engaging approach to support older adults with psychosis-an umbrella term that includes conditions such as schizophrenia, late-onset schizophrenia, and psychotic symptoms resulting from other medical or psychiatric conditions like dementia, delirium, mood disorders, or delusional disorder. As the aging population grows, a rising number of older adults are living with schizophrenia and related disorders, facing not only psychiatric symptoms like hallucinations and delusions but also cognitive impairments, reduced mobility, social isolation, and physical decline. These combined challenges significantly affect daily functioning and quality of life. At present, there are no psychosis treatment guidelines specifically tailored for people aged 60 and above, though general principles from younger populations can be adapted. Evidence suggests that integrating physical and cognitive rehabilitation into standard psychiatric care may enhance treatment outcomes for this age group. One promising method is the use of "exergames"-interactive video games that combine physical movement with cognitive challenges. These games typically require users to perform body movements such as stepping or shifting weight in response to visual and auditory cues, thereby training functions like attention, memory, balance, coordination, and executive function. Exergames offer a playful and stimulating alternative to conventional exercises and are often better accepted by older patients because of their engaging and motivating nature. Previous studies have shown that older adults with schizophrenia not only tolerate these games well but may also experience improvements in mood, cognitive function, and physical activity levels. However, past research has been limited by small sample sizes, lack of control groups, and short intervention periods. This current study, conducted at the Psychiatric University Hospital in Basel, Switzerland, seeks to examine the feasibility and benefits of using an exergame system called Dividat Senso in a more structured and controlled setting. After being screened for eligibility, participants will be randomly assigned to one of two groups. The intervention group will receive usual psychiatric inpatient care, extended with exergame-based motor-cognitive training using the Dividat Senso platform. This device requires full-body interaction, targeting both cognitive functions (such as attention, memory, and executive skills) and physical abilities (such as balance and coordination). The control group will also receive usual care, but instead of exergames, they will participate in traditional strength and balance exercises taken from the Otago falls prevention program. Both groups will train three times a week for four weeks, with each session lasting approximately 20 minutes-totaling 12 sessions. All participants will complete assessments before the intervention begins (T1) and again after four weeks (T2), to measure changes in physical activity, mental well-being, and cognitive performance. By using a structured program and comparing two active interventions, this study aims to generate more robust and generalizable findings on how technology-based, body-and-brain training can support the mental and physical health of older adults with psychosis. If proven feasible and effective, exergame-based rehabilitation could become a valuable and enjoyable addition to psychiatric treatment programs for elderly patients.
Read the detailed description
Elderly patients with psychosis can be categorized into three groups: those with a history of schizophrenia, those with a new diagnosis of schizophrenia (late-onset), and those experiencing hallucinations or delusions due to other conditions such as dementia, delirium, delusional disorder, mood disorders, or paranoid personality disorders. The elderly population with schizophrenia represents a growing segment of older adults, with an estimated prevalence of 4-6% among people over 65 years old and around 10% among those over 85. Core features associated with psychosis include hallucinations, which are perceptions without external stimuli, and delusions, which are fixed false beliefs maintained despite evidence to the contrary. Other symptoms linked to psychosis include thought interference, thought disorder, apathy, social withdrawal, and blunted affect. Currently, there are no specific guidelines for managing primary psychotic disorders in adults aged 60 and older, but some general principles can be adapted from guidelines for other age groups. Existing recommendations for adults under 60 emphasize addressing not only psychiatric symptoms but also other health factors that affect overall well-being. Given the significant impact of cognitive and physical impairments, social isolation, and sensory deficits on symptoms in older adults, an integrated approach addressing both mental and physical health could improve treatment outcomes in this population. Research has shown that greater severity of schizophrenia symptoms and neurocognitive impairments are associated with reduced levels of physical activity, and that effective physical activity interventions should include components that enhance cognition and reduce psychiatric symptoms. One specific form of physical activity is exergaming, which combines physical exercise with cognitive stimulation through gameplay. Exergames involve multisensory stimuli, including auditory, visual, and somatosensory modalities, requiring engagement of various cognitive functions such as executive functions, visual and verbal memory, attention, and other multidimensional cognitive processes. Exergames offer several advantages over conventional exercise in enhancing cognitive functions by integrating cognitive demands into physical tasks. Furthermore, exergames promote better long-term adherence to exercise due to their gamified and motivational nature. Previous studies suggest that video game-based physical activity programs have higher acceptability and adherence rates among older adults with schizophrenia. Similar results were observed in chronic psychiatric inpatient populations, where full-body interaction during computerized cognitive training led to cognitive improvements and reduced depressive symptoms. Additionally, video game-based physical activity programs have increased the frequency of self-reported physical activity among older adults with schizophrenia. Meta-analytical evidence suggests that virtual reality exergames may positively influence cognition and depression in older populations. However, current evidence is limited by small sample sizes, low participant heterogeneity, inadequate training duration and frequency, and lack of control groups. To obtain generalizable findings on the feasibility and effects of exergame-based motor-cognitive training in inpatient settings for older patients with psychosis, future research should include frequent, structured training sessions, heterogeneous samples, and control groups. Technological advancements over recent decades have increased the availability of digitalized motor-cognitive training options. One such option is the use of a "step plate" for exergame training, such as the Dividat Senso. These exergames specifically target cognitive functions essential for daily living, including executive functions, attention, as well as physical abilities like balance and coordination. The games are played through body movements and weight shifting. To examine the feasibility and effects of exergame-based motor-cognitive training in older psychiatric inpatients, we plan to use the Dividat Senso device. After eligibility screening, participants undergo baseline assessment (T1) and are randomly assigned to one of two groups. The intervention group receives conventional treatment at the psychiatric hospital extended by technology-based motor-cognitive training using Dividat Senso. The control group receives conventional treatment plus strength and balance exercises from the Otago falls-prevention program. The intervention lasts four weeks, with participants requested to engage in short training sessions three times per week for 20 minutes each, totaling 12 sessions. After the intervention period, all participants undergo a post-intervention assessment (T2).
- Conditions
- Psychosis, Exergaming, Elderly
- Being tested
- Dividat Senso, OTAGO Falls-prevention program
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dividat SensoDevice
Participants in the intervention group will receive cognitive-motor training using the Dividat Senso exergame platform, which records body movements and adapts game difficulty in real time. The training targets cognitive and physical functions through interactive games involving steps and weight shifts. It follows a progressive structure, with difficulty increasing over time, and can be personalized by investigators using the Dividat Manager.
OTAGO Falls-prevention programOther
The OTAGO Falls Prevention Program is an evidence-based exercise program designed to reduce falls in older adults. It includes strength and balance training exercises performed at home under the guidance of a physiotherapist. The program aims to improve muscle strength, balance, and mobility, helping to prevent falls and maintain independence.
| Study group | Role | What they receive |
|---|---|---|
| Dividat Senso (Exergame-Based Motor-Cognitive Training) | Experimental | Participants in this group will receive the standard psychiatric inpatient care at the Psychiatric University Hospital Basel. In addition, they will engage in technology-based motor-cognitive training using the Dividat Senso device. This system involves interactive exergames that require participants to perform body movements such as stepping and shifting weight in response to multisensory stimuli (visual, auditory, and somatosensory). The games are designed to simultaneously stimulate physical functions (balance, coordination) and cognitive functions (attention, executive function, memory). Training sessions will be conducted three times a week for four weeks, with each session lasting approximately 20 minutes, totaling 12 sessions. Receives: Device: Dividat Senso |
| OTAGO Falls-Prevention Program (Traditional Strength and Balance Exercises) | Active comparator | Participants in the control group will also receive the standard psychiatric inpatient care. Additionally, they will participate in conventional physical exercises focusing on strength and balance, based on the Otago falls prevention program. These exercises are designed to improve physical stability and reduce fall risk. Like the intervention group, participants will train three times a week for four weeks, with each session lasting about 20 minutes, totaling 12 sessions. Receives: Other: OTAGO Falls-prevention program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the exergame-based motor-cognitive training: adherence
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.
Measured: Throughout the 4-week intervention period.
Feasibility of the exergame-based motor-cognitive training: attrition
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.
Measured: Time Frame: Throughout the 4-week intervention period
Feasibility of the exergame-based motor-cognitive training: safety
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.
Measured: Time Frame: Throughout the 4-week intervention period
Secondary outcomes (10)
Cognitive function: inhibitory control
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.
Measured: Throughout the 4-week intervention period
Cognitive function: processing speed
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.
Measured: Time Frame: Throughout the 4-week intervention period
Cognitive function: selective attention
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.
Measured: Time Frame: Throughout the 4-week intervention period
Cognitive function: inhibitory control
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.
Measured: Time Frame: Throughout the 4-week intervention period
Motor function: mobility
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.
Measured: Time Frame: Throughout the 4-week intervention period
Motor function: gait speed
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.
Measured: Time Frame: Throughout the 4-week intervention period
Motor function: balance
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.
Measured: Time Frame: Throughout the 4-week intervention period
Motor function: physical activity
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.
Measured: Time Frame: Throughout the 4-week intervention period
Psychotic symptoms: patient's response to treatment
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
Measured: Time Frame: Throughout the 4-week intervention period
Psychotic symptoms: severity of psychotic symptoms
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.
Measured: Time Frame: Throughout the 4-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start9 Jun 2025
- Primary completion15 May 2027 (estimated)
- Study completion15 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tobias Melcher
- Sponsor type
- Research network
- Responsible party
- Sponsor-investigator, Tobias Melcher, University Psychiatric Clinics Basel
- Investigators
- Tobias Melcher, Dr. Dripl.Psych., Study director, Universitäre Psychiatrischen Kliniken (UPK) Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060742
- Sponsor's protocol ID
- Dividat-Psychosen25
- Status last verified
- Jul 2025
- First submitted
- 16 Jun 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yen HY, Chiu HL. Virtual Reality Exergames for Improving Older Adults' Cognition and Depression: A Systematic Review and Meta-Analysis of Randomized Control Trials. J Am Med Dir Assoc. 2021 May;22(5):995-1002. doi: 10.1016/j.jamda.2021.03.009. Epub 2021 Apr 2.
PubMed 33812843Maillot P, Perrot A, Hartley A. Effects of interactive physical-activity video-game training on physical and cognitive function in older adults. Psychol Aging. 2012 Sep;27(3):589-600. doi: 10.1037/a0026268. Epub 2011 Nov 28.
PubMed 22122605Leutwyler H, Hubbard EM, Jeste DV, Vinogradov S. "We're not just sitting on the periphery": a staff perspective of physical activity in older adults with schizophrenia. Gerontologist. 2013 Jun;53(3):474-83. doi: 10.1093/geront/gns092. Epub 2012 Aug 30.
PubMed 22936534Leutwyler H, Hubbard EM, Jeste DV, Miller B, Vinogradov S. Associations of schizophrenia symptoms and neurocognition with physical activity in older adults with schizophrenia. Biol Res Nurs. 2014 Jan;16(1):23-30. doi: 10.1177/1099800413500845. Epub 2013 Sep 19.
PubMed 24057223Leutwyler H, Hubbard EM, Dowling GA. Adherence to a Videogame-Based Physical Activity Program for Older Adults with Schizophrenia. Games Health J. 2014 Aug;3(4):227-33. doi: 10.1089/g4h.2014.0006. Epub 2014 May 28.
PubMed 26192371Leutwyler H, Hubbard E, Cooper B, Dowling G. The Impact of a Videogame-Based Pilot Physical Activity Program in Older Adults with Schizophrenia on Subjectively and Objectively Measured Physical Activity. Front Psychiatry. 2015 Dec 21;6:180. doi: 10.3389/fpsyt.2015.00180. eCollection 2015.
PubMed 26733891Camara J, Ferreira L, Faria AL, Vilar M, Bermudez I Badia S. Feasibility, Acceptability, and Preliminary Impact of Full-Body Interaction on Computerized Cognitive Training Based on Instrumental Activities of Daily Living: A Pilot Randomized Controlled Trial with Chronic Psychiatric Inpatients. Games Health J. 2022 Oct 11. doi: 10.1089/g4h.2021.0228. Online ahead of print.
PubMed 36251861
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Exergame-based Cognitive-motor Training in Older Psychotic Inpatients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07060742
- Acronym / sponsor ID
- Dividat-Psychosen25
- Conditions
- Psychosis, Exergaming, Elderly
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Tobias MelcherResearch network
- Study start
- 9 Jun 2025 (actual)
- Primary completion
- 15 May 2027 (estimated)
- Study completion
- 15 May 2028 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to explore a new, engaging approach to support older adults with psychosis-an umbrella term that includes conditions such as schizophrenia, late-onset schizophrenia, and psychotic symptoms resulting from other medical or psychiatric conditions like dementia, delirium, mood disorders, or delusional disorder. As the aging population grows, a rising number of older adults are living with schizophrenia and related disorders, facing not only psychiatric symptoms like hallucinations and delusions but also cognitive impairments, reduced mobility, social isolation, and physical decline. These combined challenges significantly affect daily functioning and quality of life. At present, there are no psychosis treatment guidelines specifically tailored for people aged 60 and above, though general principles from younger populations can be adapted. Evidence suggests that integrating physical and cognitive rehabilitation into standard psychiatric care may enhance treatment outcomes for this age group. One promising method is the use of "exergames"-interactive video games that combine physical movement with cognitive challenges. These games typically require users to perform body movements such as stepping or shifting weight in response to visual and auditory cues, thereby training functions like attention, memory, balance, coordination, and executive function. Exergames offer a playful and stimulating alternative to conventional exercises and are often better accepted by older patients because of their engaging and motivating nature. Previous studies have shown that older adults with schizophrenia not only tolerate these games well but may also experience improvements in mood, cognitive function, and physical activity levels. However, past research has been limited by small sample sizes, lack of control groups, and short intervention periods. This current study, conducted at the Psychiatric University Hospital in Basel, Switzerland, seeks to examine the feasibility and benefits of using an exergame system called Dividat Senso in a more structured and controlled setting. After being screened for eligibility, participants will be randomly assigned to one of two groups. The intervention group will receive usual psychiatric inpatient care, extended with exergame-based motor-cognitive training using the Dividat Senso platform. This device requires full-body interaction, targeting both cognitive functions (such as attention, memory, and executive skills) and physical abilities (such as balance and coordination). The control group will also receive usual care, but instead of exergames, they will participate in traditional strength and balance exercises taken from the Otago falls prevention program. Both groups will train three times a week for four weeks, with each session lasting approximately 20 minutes-totaling 12 sessions. All participants will complete assessments before the intervention begins (T1) and again after four weeks (T2), to measure changes in physical activity, mental well-being, and cognitive performance. By using a structured program and comparing two active interventions, this study aims to generate more robust and generalizable findings on how technology-based, body-and-brain training can support the mental and physical health of older adults with psychosis. If proven feasible and effective, exergame-based rehabilitation could become a valuable and enjoyable addition to psychiatric treatment programs for elderly patients.
Detailed description
Elderly patients with psychosis can be categorized into three groups: those with a history of schizophrenia, those with a new diagnosis of schizophrenia (late-onset), and those experiencing hallucinations or delusions due to other conditions such as dementia, delirium, delusional disorder, mood disorders, or paranoid personality disorders. The elderly population with schizophrenia represents a growing segment of older adults, with an estimated prevalence of 4-6% among people over 65 years old and around 10% among those over 85. Core features associated with psychosis include hallucinations, which are perceptions without external stimuli, and delusions, which are fixed false beliefs maintained despite evidence to the contrary. Other symptoms linked to psychosis include thought interference, thought disorder, apathy, social withdrawal, and blunted affect. Currently, there are no specific guidelines for managing primary psychotic disorders in adults aged 60 and older, but some general principles can be adapted from guidelines for other age groups. Existing recommendations for adults under 60 emphasize addressing not only psychiatric symptoms but also other health factors that affect overall well-being. Given the significant impact of cognitive and physical impairments, social isolation, and sensory deficits on symptoms in older adults, an integrated approach addressing both mental and physical health could improve treatment outcomes in this population. Research has shown that greater severity of schizophrenia symptoms and neurocognitive impairments are associated with reduced levels of physical activity, and that effective physical activity interventions should include components that enhance cognition and reduce psychiatric symptoms. One specific form of physical activity is exergaming, which combines physical exercise with cognitive stimulation through gameplay. Exergames involve multisensory stimuli, including auditory, visual, and somatosensory modalities, requiring engagement of various cognitive functions such as executive functions, visual and verbal memory, attention, and other multidimensional cognitive processes. Exergames offer several advantages over conventional exercise in enhancing cognitive functions by integrating cognitive demands into physical tasks. Furthermore, exergames promote better long-term adherence to exercise due to their gamified and motivational nature. Previous studies suggest that video game-based physical activity programs have higher acceptability and adherence rates among older adults with schizophrenia. Similar results were observed in chronic psychiatric inpatient populations, where full-body interaction during computerized cognitive training led to cognitive improvements and reduced depressive symptoms. Additionally, video game-based physical activity programs have increased the frequency of self-reported physical activity among older adults with schizophrenia. Meta-analytical evidence suggests that virtual reality exergames may positively influence cognition and depression in older populations. However, current evidence is limited by small sample sizes, low participant heterogeneity, inadequate training duration and frequency, and lack of control groups. To obtain generalizable findings on the feasibility and effects of exergame-based motor-cognitive training in inpatient settings for older patients with psychosis, future research should include frequent, structured training sessions, heterogeneous samples, and control groups. Technological advancements over recent decades have increased the availability of digitalized motor-cognitive training options. One such option is the use of a "step plate" for exergame training, such as the Dividat Senso. These exergames specifically target cognitive functions essential for daily living, including executive functions, attention, as well as physical abilities like balance and coordination. The games are played through body movements and weight shifting. To examine the feasibility and effects of exergame-based motor-cognitive training in older psychiatric inpatients, we plan to use the Dividat Senso device. After eligibility screening, participants undergo baseline assessment (T1) and are randomly assigned to one of two groups. The intervention group receives conventional treatment at the psychiatric hospital extended by technology-based motor-cognitive training using Dividat Senso. The control group receives conventional treatment plus strength and balance exercises from the Otago falls-prevention program. The intervention lasts four weeks, with participants requested to engage in short training sessions three times per week for 20 minutes each, totaling 12 sessions. After the intervention period, all participants undergo a post-intervention assessment (T2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dividat Senso (Exergame-Based Motor-Cognitive Training) | Experimental | Device: Dividat SensoParticipants in this group will receive the standard psychiatric inpatient care at the Psychiatric University Hospital Basel. In addition, they will engage in technology-based motor-cognitive training using the Dividat Senso device. This system involves interactive exergames that require participants to perform body movements such as stepping and shifting weight in response to multisensory stimuli (visual, auditory, and somatosensory). The games are designed to simultaneously stimulate physical functions (balance, coordination) and cognitive functions (attention, executive function, memory). Training sessions will be conducted three times a week for four weeks, with each session lasting approximately 20 minutes, totaling 12 sessions. |
| OTAGO Falls-Prevention Program (Traditional Strength and Balance Exercises) | Active comparator | Other: OTAGO Falls-prevention programParticipants in the control group will also receive the standard psychiatric inpatient care. Additionally, they will participate in conventional physical exercises focusing on strength and balance, based on the Otago falls prevention program. These exercises are designed to improve physical stability and reduce fall risk. Like the intervention group, participants will train three times a week for four weeks, with each session lasting about 20 minutes, totaling 12 sessions. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed psychotic disorders
- Able to provide a signed informed consent
- Age ≥ 55 years
- MoCA ≥ 20
- Physically able to stand for at least 3 minutes without external support (self-report)
Key exclusion criteria (2 listed)
- Insufficient knowledge of the German language to understand the instructions, the games, and the assessments
- Mobility, cognitive, sensory and/or psychiatric limitations or comorbidities that impair the ability to play the exergames and/or conduct the pre-/post assessments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dividat SensoParticipants in the intervention group will receive cognitive-motor training using the Dividat Senso exergame platform, which records body movements and adapts game difficulty in real time. The training targets cognitive and physical functions through interactive games involving steps and weight shifts. It follows a progressive structure, with difficulty increasing over time, and can be personalized by investigators using the Dividat Manager. | Device | Dividat Senso (Exergame-Based Motor-Cognitive Training) |
| OTAGO Falls-prevention programThe OTAGO Falls Prevention Program is an evidence-based exercise program designed to reduce falls in older adults. It includes strength and balance training exercises performed at home under the guidance of a physiotherapist. The program aims to improve muscle strength, balance, and mobility, helping to prevent falls and maintain independence. | Other | OTAGO Falls-Prevention Program (Traditional Strength and Balance Exercises) |
Primary outcome
Feasibility of the exergame-based motor-cognitive training: adherence
Time frame: Throughout 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.
Feasibility of the exergame-based motor-cognitive training: attrition
Time frame: Time 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.
Feasibility of the exergame-based motor-cognitive training: safety
Time frame: Time 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.
10 secondary outcomes
Cognitive function: inhibitory control
Time frame: Throughout the 4-week intervention period
Cognitive function: processing speed
Time frame: Time Frame: Throughout the 4-week intervention period
Cognitive function: selective attention
Time frame: Time Frame: Throughout the 4-week intervention period
Cognitive function: inhibitory control
Time frame: Time Frame: Throughout the 4-week intervention period
Motor function: mobility
Time frame: Time Frame: Throughout the 4-week intervention period
Motor function: gait speed
Time frame: Time Frame: Throughout the 4-week intervention period
Motor function: balance
Time frame: Time Frame: Throughout the 4-week intervention period
Motor function: physical activity
Time frame: Time Frame: Throughout the 4-week intervention period
Psychotic symptoms: patient's response to treatment
Time frame: Time Frame: Throughout the 4-week intervention period
Psychotic symptoms: severity of psychotic symptoms
Time frame: Time Frame: Throughout the 4-week intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Background: PubMed 33812843Yen HY, Chiu HL. Virtual Reality Exergames for Improving Older Adults' Cognition and Depression: A Systematic Review and Meta-Analysis of Randomized Control Trials. J Am Med Dir Assoc. 2021 May;22(5):995-1002. doi: 10.1016/j.jamda.2021.03.009. Epub 2021 Apr 2.
- Background: PubMed 22122605Maillot P, Perrot A, Hartley A. Effects of interactive physical-activity video-game training on physical and cognitive function in older adults. Psychol Aging. 2012 Sep;27(3):589-600. doi: 10.1037/a0026268. Epub 2011 Nov 28.
- Background: PubMed 22936534Leutwyler H, Hubbard EM, Jeste DV, Vinogradov S. "We're not just sitting on the periphery": a staff perspective of physical activity in older adults with schizophrenia. Gerontologist. 2013 Jun;53(3):474-83. doi: 10.1093/geront/gns092. Epub 2012 Aug 30.
- Background: PubMed 24057223Leutwyler H, Hubbard EM, Jeste DV, Miller B, Vinogradov S. Associations of schizophrenia symptoms and neurocognition with physical activity in older adults with schizophrenia. Biol Res Nurs. 2014 Jan;16(1):23-30. doi: 10.1177/1099800413500845. Epub 2013 Sep 19.
- Background: PubMed 26192371Leutwyler H, Hubbard EM, Dowling GA. Adherence to a Videogame-Based Physical Activity Program for Older Adults with Schizophrenia. Games Health J. 2014 Aug;3(4):227-33. doi: 10.1089/g4h.2014.0006. Epub 2014 May 28.
- Background: PubMed 26733891Leutwyler H, Hubbard E, Cooper B, Dowling G. The Impact of a Videogame-Based Pilot Physical Activity Program in Older Adults with Schizophrenia on Subjectively and Objectively Measured Physical Activity. Front Psychiatry. 2015 Dec 21;6:180. doi: 10.3389/fpsyt.2015.00180. eCollection 2015.
- Background: PubMed 36251861Camara J, Ferreira L, Faria AL, Vilar M, Bermudez I Badia S. Feasibility, Acceptability, and Preliminary Impact of Full-Body Interaction on Computerized Cognitive Training Based on Instrumental Activities of Daily Living: A Pilot Randomized Controlled Trial with Chronic Psychiatric Inpatients. Games Health J. 2022 Oct 11. doi: 10.1089/g4h.2021.0228. Online ahead of print.
- The Dividat Senso is a scientifically validated exergame platform that combines cognitive and physical training through interactive step-based games, enhancing balance, coordination, and mental function in older adults and clinical populations.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tobias Melcher, Dr. Dripl.Psych. study director
Universitäre Psychiatrischen Kliniken (UPK) Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dividat Senso and OTAGO Falls-prevention program in people with Psychosis and Exergaming, run by Tobias Melcher at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tobias Melcher, Dr. Dipl.-Psych. (+41 61 325 5163, tobias.melcher@upk.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the exergame-based motor-cognitive training: adherence (time frame: Throughout the 4-week intervention period.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07060742, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.