NCT07209592

Brief 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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
2mo left

Started Oct 2025

Shorter than P25 for not_applicable stroke

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress79%
Oct 2025Jun 2026

First Submitted

Initial submission to the registry

September 29, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 7, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

October 15, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

October 7, 2025

Status Verified

September 1, 2025

Enrollment Period

9 months

First QC Date

September 29, 2025

Last Update Submit

September 29, 2025

Conditions

Keywords

Artificial Intelligence Based Gamification TrainingCognitionFunctional Outcomes

Outcome Measures

Primary Outcomes (4)

  • 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.

    up to four weeks

  • 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.

    up to four weeks

  • handgrip strength

    A handheld dynamometer will be used for assessing hand grip strength

    up to four weeks

  • kinetic motion analysis

    X - Box kinetic motion sensor devcie will be used for assessing motion analysis

    up to four weeks

Study Arms (2)

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

Other: AI gamificationOther: conventional therapy

conventional therapy

ACTIVE COMPARATOR

twenty patients will receive conventional therapy exercises three times per weeks for four weeks

Other: conventional therapy

Interventions

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 6 minutes , three times per week for 4 weeks. The patients Will receive AI gamification via X-box with 3 D kinetic motion analysis 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

AI gamification

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

AI gamificationconventional therapy

Eligibility Criteria

Age45 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Mai shehab, master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
opaque sealed envelope
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Artificial Intelligence Based Gamification Training and Exercise Program
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator : mai rabee ahmed shehab

Study Record Dates

First Submitted

September 29, 2025

First Posted

October 7, 2025

Study Start

October 15, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

October 7, 2025

Record last verified: 2025-09