Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Post Stroke Aphasia Rehabilitation Using Computer-based Arabic Software Program: A Randomized Control Trial (aphasia)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04717180
Recruitment Status : Completed
First Posted : January 22, 2021
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Alexandria University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Aphasia is a disorder of language processing caused by a lesion in particular brain regions. Treatment aims at improving or restoring impaired function or at compensating for deficits. More recently, computer technology has been integrated into treatment options. In this study, a detailed and comprehensive computerized software program for aphasia rehabilitation is designed for the treatment of Arabic speaking Egyptian aphasic patients.

Aim of the study: design a computerized software program for the rehabilitation of Arabic speaking Egyptian aphasic patients.


Condition or disease Intervention/treatment Phase
Aphasia Rehabilitation Behavioral: aphasia rehabilitation using software program or conventional therapy Not Applicable

Detailed Description:

Aphasia is a disorder of language processing caused by a lesion in particular brain regions. Treatment aims at improving or restoring impaired function or at compensating for deficits. More recently, computer technology has been integrated into treatment options. In this study, a detailed and comprehensive computerized software program for aphasia rehabilitation is designed for the treatment of Arabic speaking Egyptian aphasic patients.

Aim of the study: design a computerized software program for the rehabilitation of Arabic speaking Egyptian aphasic patients.

Subjects: The study was conducted on 50 patients with aphasia who attend the unit of Phoniatrics during the period of one year, Department of Otorhinolaryngology, Alexandria Main University Hospitals.

Methodology: The training materials were designed as a software program. Each patient was subjected to assessment before and after the application of the rehabilitation program. Patients were randomized into two groups: group I who received therapy using the software aphasia rehabilitation program and group II who received conventional (traditional) language therapy. Therapy continued for 48 sessions over six months.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Post Stroke Aphasia Rehabilitation Using Computer-based Arabic Software Program: A Randomized Control Trial
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : September 15, 2019
Actual Study Completion Date : June 20, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: group I
patients who received rehabilitation using the software program for aphasia rehabilitation
 Behavioral: aphasia rehabilitation using software program or conventional therapy
Patients were randomized into two groups: group I who received therapy using the software aphasia rehabilitation program and group II who received conventional (traditional) language therapy
Other Name: aphasia rehabilitation using the conventional language therapy
Active Comparator: group II
patients who received rehabilitation using the conventional therapy
 Behavioral: aphasia rehabilitation using software program or conventional therapy
Patients were randomized into two groups: group I who received therapy using the software aphasia rehabilitation program and group II who received conventional (traditional) language therapy
Other Name: aphasia rehabilitation using the conventional language therapy


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. The primary outcome was a measure of improvement in language abilities. [ Time Frame: 6 months ]
    The primary outcome was a measure of improvement in language abilities. It was measured (after 48 sessions) using Boston Diagnostic Aphasia Examination (BDAE) Arabic version to detect any significant improvement in language


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of aphasia
  • Age 18 years or more

Exclusion Criteria:

  • Intellectual disabilities.
  • Visual impairment.
  • Hearing impairment.
  • Associated dysarthria and or apraxia of speech.
  • Associated psychiatric disorders
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04717180


Locations
Layout table for location information
Egypt
Alexandria Main University Hospitals
Alexandria, Egypt, 21131
Sponsors and Collaborators
Alexandria University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Alexandria University
ClinicalTrials.gov Identifier: NCT04717180    
Other Study ID Numbers: aphasia software
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexandria University:
aphasia, post stroke
Additional relevant MeSH terms:
Layout table for MeSH terms
Aphasia
Nervous System Diseases
Speech Disorders
Language Disorders
 Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations