NCT03890159

Brief 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Apr 2019

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 26, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

1 year

First QC Date

March 22, 2019

Last Update Submit

March 25, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Beck Depression Index

    Baseline, Month 1

  • Quality of Life Assessment

    1 month

  • Functional Independence

    1 month

Study Arms (3)

Computer Assisted Cognitive Rehabilitation

EXPERIMENTAL

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

Conventional Cognitive Rehabilitation

EXPERIMENTAL

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

Waiting list controls

NO INTERVENTION

These patients will get no intervention as means of cognitive rehabilitation, but will get their usual treatments.

Interventions

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.

Computer Assisted 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.

Conventional Cognitive Rehabilitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients over 18 years of age with stroke

You may not qualify if:

  • Problems with sight
  • Comorbid neurological disease
  • Cognitive impairment prior to stroke
  • Neglect Syndrome
  • Wernicke or Global aphasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Hale Karapolat, M.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Physical Medicine and Rehabilitation Department

Study Record Dates

First Submitted

March 22, 2019

First Posted

March 26, 2019

Study Start

April 1, 2019

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

March 26, 2019

Record last verified: 2019-03