Effects of Computer Assisted Cognitive Rehabilitation on Patients With Stroke

Stroke Clinical Trial

Official title:

Effects of Computer Assisted Cognitive Rehabilitation on Patients With Stroke in Attention, Functional Independence and Quality of Life

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03890159
• Other study ID #: Stroke-CACR
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: March 2019
• Source: Ege University
• Contact: Hale Karapolat, M.D.
• Phone: +902323903682
• Email: halekarapolat[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to investigate the effects of computer assisted cognitive rehabilitation and conventional cognitive rehabilitation methods on patients' attention, quality of life and functional independence. Recruiting from 15 patients from each group, patients will be followed up for a month and the outcome measures will be repeated.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients over 18 years of age with stroke

Exclusion Criteria:

• Problems with sight

• Comorbid neurological disease

• Cognitive impairment prior to stroke

• Neglect Syndrome

• Wernicke or Global aphasia

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Computer Assited Cognitive rehabilitation
Patients will receive their therapies 1 day a day, 2-3 days a week. The computer-aided cognitive rehabilitation group will perform simulation-based exercises, including exercises related to attention, in a special computer program (Cogniplus TR version) during therapy hours. The total duration of intervention will be 1 month.
• Conventional Cognitive Rehabilitation
Patients will receive their therapies 1 day a day, 2-3 days a week. The home (paper pen) exercise group will take the necessary exercises on paper suitable for their respective levels and the daily tasks suitable for their functional needs and interests. The total duration of intervention will be 1 month.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroop test	Stroop test is a quick measurement for ability of color perception and focusing attention Participants are asked to read 112 words with color within 2 min. Then, they are required to tell the color of these 112 words as color-word association. Finally, time of accomplishing task and number of correct read, corrections and errors are examined.	1 month
Primary	Trail making	Trail making test is used to evaluate the attention and velocity. Participants are asked to sequentially connect 25 circles with number which was written in only one style (Line A), or to sequentially connect 25 circles with number which was written in two styles (Line B). The time used to complete the line A or B and the number of errors and fouls are recorded and analyzed.	1 month
Secondary	Beck Depression Index	It is a test frequently used to assess depressive symptoms in chronic diseases. It is comprised of 21 items, 8 of which investigate the somatic symptoms of depression (such as loss of appetite and difficulty sleeping) and 13 of which address the cognitive-affective symptoms of depression (e.g., despair, social withdrawal). The BDI is scored as follows: 0-9: no symptoms; 10-16: mild depression; 17-29: moderate depression; and 30-63: severe depression	Baseline, Month 1
Secondary	Quality of Life Assessment	Medical Outcomes Study 36-item Short Form Survey (SF-36). This is one of the most widely used scales evaluating quality of life. The SF-36 explores eight dimensions of the quality of life "physical function", "physical role", "bodily pain", "general health", "vitality", "social function", "emotional role" and "mental health". All scales were linearly transformed to a 0 to 100 scoring, with 100 indicating most favorable health state and 0 indicating the least favorable health state	1 month
Secondary	Functional Independence	The FIM is a generic and global activity scale that measures an individual's independence in conducting his or her daily fundamental physical and cognitive activities. The FIM measures 81 items in two areas: 1) physical/motor function (13 items) and 2) cognitive/ psychosocial function (5 items). The items are divided into six subgroups according to activities, four physical and two cognitive. Each item is scored on a scale of one to seven, with "level 1" indicating that the patient needs complete help and "level 7" indicating complete independence. The total FIM score varies between 18 and 126.	1 month