StrokeAINCT07209592
Effect of Artificial Intelligence Based Gamification Training on Cognition and Functional Outcomes in Patients With Stroke
A study testing AI gamification and conventional therapy in people with Stroke, run by Cairo University at 1 site in Egypt.
Trial summary
this study will be conducted to investigate the effect of artificial intelligence based gamification training on cognition and functional outcomes in patients with stroke Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Stroke
- What is being tested?
- AI gamification and conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Forty hemiplegic patients with mild post stroke cognitive impairment.
- The patients age will be 45 to 60.
- Chronic stroke (6 months post-stroke).
- Score of 1 to 1+ to points on the Modified Ashworth Scale (MAS) on upper limb (shoulder , elbow ,hand).
- Stage of recovery 4-5 brunnstrom
- Essential educational level ( at least high school level)
- BMI will be ranged from 18,5 -24.9 kg\m2
Who cannot join
- Moderate and severe post stroke cognitive impairment
- Excluding cognitive impairment for any other psychological or neurological disease such as depression and dementia
- history of recent upper limb surgery
- Any musculoskeletal disorders of upper extremity (e.g fractures or injuries)
- Having a heart pacemaker, pregnancy
- Other neurological diseases or cancer
- Hormonal disturbances
Trial locations and contacts
1 site in 1 country.
About this study
this study will be conducted to investigate the effect of artificial intelligence based gamification training on cognition and functional outcomes in patients with stroke
Read the detailed description
Stroke is a neurological disorder characterized by blockage of blood vessels. Clots form in the brain and interrupt blood flow, clogging arteries and causing blood vessels to break, leading to bleeding. Rupture of the arteries leading to the brain during stroke results in the sudden death of brain cells owing to a lack of oxygen. Stroke can also lead to depression and dementia.Cognitive impairment refers to a broad range of deficits in cognitive function, including memory, attention, executive function, language, and visuo-spatial skills. Understanding the connection between stroke and cognitive impairment is crucial for effectively managing symptoms and improving stroke survivors' quality of life.Gamified interventions outperformed conventional therapies in reducing task, completion time , Sustained Engagement. AI-driven adaptive systems, such as the Bright Brainer Grasp (BBG) controller, increased patient motivation by dynamically adjusting difficulty levels based on real-time performance reducing caregiver oversight. BCI and Gamification Synergy , Brain-Computer Interface (BCI) systems combined with gamified tasks (e.g., CoWMeG) improved upper limb motor function. Motor Imagery: Enhanced neural plasticity through imagined movements .Mirror Neuron Activation: Visual feedback from avatars reinforced motor learning..Therefore this study will be designed to investigate the effect of gamification AI based training on cognition in patients with stroke.
- Conditions
- Stroke
- Being tested
- AI gamification, conventional therapy
- Keywords
- Artificial Intelligence Based Gamification Training, Cognition, Functional Outcomes
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI gamificationOther
The treatment program for AI gamification group will be in the form of cognitive tasks accompanied by cognitive driven motor tasks ( integrating cognitive strategies into motor tasks) exercises of the upper limb (shoulder, elbow, hand) in the form of AI gamification model. For each patient in study group, session will be for 60 minutes , three times per week for 4 weeks. The patients Will receive AI gamification via VR giving the patient real time feedback, visual and auditory feedback about the range and task .Using this technology we will gain the benefits of both AI and Gamification, the patients will be engaged in the exercise intensively and for a longer time with out getting bored and the tasks will be enjoyable to capture their attention , in addition to traditional training plus conventional therapy
conventional therapyOther
the patiens will receive conventional therapy exercises in the form of flexibility exercises, strengthening exercises, Aerobic training exercise
- flexibility exercises , it will be in the form of functional stretching for shoulder adductors and flexors, elbow flexors ,wrist and finger flexors
- strengthening exercises , it will be mainly strengthening exercises for upper limb (shoulder extensors, elbow , wrist and finger extensors) in addition to trunk control exercises targeting proximal stability for distal mobility.
Aerobic training exercise, as a form of cognitive training exercises
| Study group | Role | What they receive |
|---|---|---|
| AI gamification | Experimental | twenty patients will receive cognitive tasks accompanied by cognitive-driven motor tasks by AI gamification plus conventional therapy three times per weeks for four weeks Receives: Other: AI gamification; Other: conventional therapy |
| conventional therapy | Active comparator | twenty patients will receive conventional therapy exercises three times per weeks for four weeks Receives: Other: conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive disability
cognition will be measured by Smart phone- based cognitive assessement allows older adults to be more engaged in cognitive screening and monitoring both inside and outside the clinic. It provide advantages over the traditional cognitive testing such as cost ,time saving, more detailed response metric recordings, automated data collection and scoring.
Measured: up to four weeks
Secondary outcomes (3)
upper limb function
Wolf Motor Functional scale will be used for assessment of upper limb function.The original version of the WMFT consisted of 21 items. The widely used version of the WMFT consists of 17 items .It is composed of three parts namely, time, functional ability (items 1-6) and strength (items 7-14). Remaining 9 items involves analysing movement quality when completing various tasks. The less affected side is tested first, followed by the affected limb. The following tasks should be completed as quickly as possible, with a 120-second time limit.
Measured: up to four weeks
Kinovea motion analysis
Kinovea for assessment of shoulder ROM and Timing
Measured: up to four weeks
handgrip strength
A handheld dynamometer will be used for assessing hand grip strength
Measured: up to four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start1 Jan 2026
- Primary completion1 Aug 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Model description
- Artificial Intelligence Based Gamification Training and Exercise Program
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Rabee Shehab, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209592
- Sponsor's protocol ID
- P.T.REC/012/005963
- Acronym
- AI
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Artificial Intelligence Based Gamification Training on Cognition and Functional Outcomes in Patients With Stroke
- ClinicalTrials.gov ID
- NCT07209592
- Acronym / sponsor ID
- AI / P.T.REC/012/005963
- Conditions
- Stroke
- Keywords
- Artificial Intelligence Based Gamification Training, Cognition, Functional Outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 7 Oct 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 will be conducted to investigate the effect of artificial intelligence based gamification training on cognition and functional outcomes in patients with stroke
Detailed description
Stroke is a neurological disorder characterized by blockage of blood vessels. Clots form in the brain and interrupt blood flow, clogging arteries and causing blood vessels to break, leading to bleeding. Rupture of the arteries leading to the brain during stroke results in the sudden death of brain cells owing to a lack of oxygen. Stroke can also lead to depression and dementia.Cognitive impairment refers to a broad range of deficits in cognitive function, including memory, attention, executive function, language, and visuo-spatial skills. Understanding the connection between stroke and cognitive impairment is crucial for effectively managing symptoms and improving stroke survivors' quality of life.Gamified interventions outperformed conventional therapies in reducing task, completion time , Sustained Engagement. AI-driven adaptive systems, such as the Bright Brainer Grasp (BBG) controller, increased patient motivation by dynamically adjusting difficulty levels based on real-time performance reducing caregiver oversight. BCI and Gamification Synergy , Brain-Computer Interface (BCI) systems combined with gamified tasks (e.g., CoWMeG) improved upper limb motor function. Motor Imagery: Enhanced neural plasticity through imagined movements .Mirror Neuron Activation: Visual feedback from avatars reinforced motor learning..Therefore this study will be designed to investigate the effect of gamification AI based training on cognition in patients with stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Artificial Intelligence Based Gamification Training and Exercise Program
| Arm | Type | Receives |
|---|---|---|
| AI gamification | Experimental | Other: AI gamification, Other: conventional therapytwenty patients will receive cognitive tasks accompanied by cognitive-driven motor tasks by AI gamification plus conventional therapy three times per weeks for four weeks |
| conventional therapy | Active comparator | Other: conventional therapytwenty patients will receive conventional therapy exercises three times per weeks for four weeks |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Forty hemiplegic patients with mild post stroke cognitive impairment.
- The patients age will be 45 to 60.
- Chronic stroke (6 months post-stroke).
- Score of 1 to 1+ to points on the Modified Ashworth Scale (MAS) on upper limb (shoulder , elbow ,hand).
- Stage of recovery 4-5 brunnstrom
Key exclusion criteria (7 listed)
- Moderate and severe post stroke cognitive impairment
- Excluding cognitive impairment for any other psychological or neurological disease such as depression and dementia
- history of recent upper limb surgery
- Any musculoskeletal disorders of upper extremity (e.g fractures or injuries)
- Having a heart pacemaker, pregnancy
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 |
|---|---|---|
| AI gamificationThe treatment program for AI gamification group will be in the form of cognitive tasks accompanied by cognitive driven motor tasks ( integrating cognitive strategies into motor tasks) exercises of the upper limb (shoulder, elbow, hand) in the form of AI gamification model. For each patient in study group, session will be for 60 minutes , three times per week for 4 weeks. The patients Will receive AI gamification via VR giving the patient real time feedback, visual and auditory feedback about the range and task .Using this technology we will gain the benefits of both AI and Gamification, the patients will be engaged in the exercise intensively and for a longer time with out getting bored and the tasks will be enjoyable to capture their attention , in addition to traditional training plus conventional therapy | Other | AI gamification |
| conventional therapythe patiens will receive conventional therapy exercises in the form of flexibility exercises, strengthening exercises, Aerobic training exercise * flexibility exercises , it will be in the form of functional stretching for shoulder adductors and flexors, elbow flexors ,wrist and finger flexors * strengthening exercises , it will be mainly strengthening exercises for upper limb (shoulder extensors, elbow , wrist and finger extensors) in addition to trunk control exercises targeting proximal stability for distal mobility. Aerobic training exercise, as a form of cognitive training exercises | Other | AI gamification, conventional therapy |
Primary outcome
cognitive disability
Time frame: up to four weeks
cognition will be measured by Smart phone- based cognitive assessement allows older adults to be more engaged in cognitive screening and monitoring both inside and outside the clinic. It provide advantages over the traditional cognitive testing such as cost ,time saving, more detailed response metric recordings, automated data collection and scoring.
3 secondary outcomes
upper limb function
Time frame: up to four weeks
Kinovea motion analysis
Time frame: up to four weeks
handgrip strength
Time frame: up to four weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
Related trials for Stroke
Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
RecruitingPhase 3
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
Atrial Fibrillation (AF)
Not yet recruiting
The Effects of an Augmented Reality-Based Mirror Therapy System in Patients With Stroke
Stroke
Recruiting
A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With Acute Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
Role of EEG in Differentiation Between Ischemic and Hemorrhagic Stroke
Acute Ischemic Stroke, Acute Haemorrhagic Stroke
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI gamification and conventional therapy in people with Stroke, run by Cairo University at 1 site in Egypt.
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 7 inclusion and 7 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: finished, as of the sponsor's last update on 16 Sep 2026. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive disability (time frame: up to four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2026.