Effects of Computer Assisted Cognitive Rehabilitation on Patients With Stroke

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

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.

Study Overview

• Status: Unknown
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Computer Assited Cognitive rehabilitation; Behavioral: Conventional Cognitive Rehabilitation

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hale Karapolat, M.D.; Phone Number: +902323903682; Email: halekarapolat@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Computer Assisted 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, and patients will progress to the difficulty level automatically. Their performance during this process (response time etc.) will be recorded.	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.
EXPERIMENTAL: Conventional Cognitive Rehabilitation; 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.	Behavioral: 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.
NO_INTERVENTION: Waiting list controls; These patients will get no intervention as means of cognitive rehabilitation, but will get their usual treatments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Ege University

Publications and helpful links

General Publications

• Gibson E, Koh CL, Eames S, Bennett S, Scott AM, Hoffmann TC. Occupational therapy for cognitive impairment in stroke patients. Cochrane Database Syst Rev. 2022 Mar 29;3(3):CD006430. doi: 10.1002/14651858.CD006430.pub3.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2019
• Primary Completion (ANTICIPATED): April 1, 2020
• Study Completion (ANTICIPATED): April 1, 2020

Study Registration Dates

• First Submitted: March 22, 2019
• First Submitted That Met QC Criteria: March 25, 2019
• First Posted (ACTUAL): March 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 26, 2019
• Last Update Submitted That Met QC Criteria: March 25, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: Stroke-CACR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No