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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06378606
Other study ID # P.T.REC/012/004907
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2023
Est. completion date June 1, 2024

Study information

Verified date April 2024
Source Cairo University
Contact nourhan hisham ali
Phone 01156860154
Email nourheshame854@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Aging over 60 years is associated with some progressive decline in cognitive domains, such as processing speed and executive function. A significant decline in cognitive function, particularly memory, which is an early symptom of dementia, can lead to mild cognitive impairment (MCI). Currently it is estimated that 50 million are living with dementia worldwide and nearly 10 million new cases occur every year, representing a serious public health problem. As such, the WHO has suggested that preventing cognitive decline and dementia is a global mental health priority. In addition to impacting the patient, dementia also has a significant impact on the family and society in general. Age is the biggest risk factor for the development of dementia, and aging is associated with a decline of cognitive function. Non-pharmacological interventions such as physical exercise and cognitive interventions may offer an alternative to pharmacological intervention in delaying dementia-related functional decline. Over the last decade, the accessibility and use of computers, smartphones and mobile internet has quickly expanded . 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date June 1, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 85 Years
Eligibility Inclusion criteria 1- Age = 65 years. 2- Literate with = 15 years of education. 3- Older adults with mild dementia. 4- Montreal cognitive assessment score 18-26 .( Pinto et al .,2019). 5- Android smartphone user. 6- Well ability to write and read. Exclusion criteria 1. Major Cardiovascular events , such as Stroke or Myocardial infraction in past three months. 2. Alzheimer's disease. 3. Sever cognitive dementia. 4. Sever hearing difficulty or visual disturbance. 5. Brain injury. 6. Limitation in communications. 7. Chronic kidney diseases. 8. Liver diseases. 9. Low or high educated. 10. Uncontrolled diabetic patients. 11. Thyroid disturbance. 12. Mental and psychological instability .

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
cognitive therapy
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.

Locations

Country Name City State
Egypt Nour Ali Cairo Giza

Sponsors (2)

Lead Sponsor Collaborator
Nourhan Hesham Ali Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Quality of life survey Quality of life : it was assessed by SF-12 health survey quality of life questionnaire.
The SF-12 is a generic, standardized questionnaire used to meas- ure two components of HRQoL: physical and mental health. . It is a shorter, yet valid alternative to the most widely used health status scale: the Short-Form-36 Health Survey Questionnaire (SF-36). The SF-12 reproduces the physical and mental component summary scores (PCS/MCS) of the SF-36. In addition, as the SF-12 contains fewer questions and takes less time to complete than the SF-36, it is more appropriate for use with older adults with common geriatric diseases, such as dementia .There scores range from zero (lowest HRQoL)-100 (highest)
1 year
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