NCT06378606

Brief Summary

Cognitive technology therapies, including interactive video gaming, computer soft wares and mobile technology, have been used to implement cognitive training and rehabilitation programs. Potential advantages to using technology-based interventions include enhanced accessibility and cost-effectiveness, providing a user experience to be good communicator, immersive and comprehensive.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
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 Start

First participant enrolled

July 1, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 22, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

April 22, 2024

Status Verified

April 1, 2024

Enrollment Period

11 months

First QC Date

February 25, 2024

Last Update Submit

April 18, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cognitive functions assessment

    Cognitive function : It was assessed by rehacom software and Montreal cognitive assessment (MoCA) which are a highly sensitive and specific screening tool for patients with impaired cognitive function. 1- Rehacom software screening: 9 screening modules detect cognitive functions: 4Attention, 2memory, 1logical reasoning and 2 visual field. Montreal test is a short in duration (10- 15 min) 30-point screening test that measures a number of cognitive domains such as visuospatial abilities, executive function, short-term memory, attention/concentration, language, abstract thinking, and orientation. . Patients with MoCA scores of less than 26 are considered cognitively impaired Arabic version was used

    1 year

Secondary Outcomes (1)

  • Quality of life survey

    1 year

Study Arms (3)

group A

ACTIVE COMPARATOR

(Therapy group) It will include subjects that will receive computer based cognitive therapy sessions training. omega 3 supplement .

Behavioral: cognitive therapy

Group B

EXPERIMENTAL

(Smartphone group) It will include subjects that will receive home program training by using their smartphones cognitive applications . omega 3 supplement .

Behavioral: cognitive therapy

group c

PLACEBO COMPARATOR

It won't receive interventions. only omega 3 supplement

Behavioral: cognitive therapy

Interventions

intervention : group A: recive computer cognitive traing by rehacom system and omega 3 supplement . group B: recive smart phone cognitive application and omega 3 supplement . group c recive omega 3 supplement only.

Also known as: cognitive training
Group Bgroup Agroup c

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may not qualify if:

  • Major Cardiovascular events , such as Stroke or Myocardial infraction in past three months.
  • Alzheimer's disease.
  • Sever cognitive dementia.
  • Sever hearing difficulty or visual disturbance.
  • Brain injury.
  • Limitation in communications.
  • Chronic kidney diseases.
  • Liver diseases.
  • Low or high educated.
  • Uncontrolled diabetic patients.
  • Thyroid disturbance.
  • Mental and psychological instability .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nour Ali

Cairo, Giza Governorate, 12511, Egypt

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Cognitive Behavioral TherapyCognitive Training

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesNeurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • ahmed mahdi ahmed

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

nourhan hisham ali

CONTACT

kareem adel mohamed

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The aim of study is to find the effects of screen based cognitive therapy on mild dementia in elderly .
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: The aim of study is to find the effects of screen based cognitive therapy on mild dementia in elderly .
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
physiotherapist /Nourhan Hisham Ali

Study Record Dates

First Submitted

February 25, 2024

First Posted

April 22, 2024

Study Start

July 1, 2023

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

April 22, 2024

Record last verified: 2024-04

Locations