Post Stroke Aphasia Rehabilitation Using Computer-based Arabic Software Program: A Randomized Control Trial (aphasia)
Primary Purpose
Aphasia Rehabilitation
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
aphasia rehabilitation using software program or conventional therapy
Sponsored by
About this trial
This is an interventional treatment trial for Aphasia Rehabilitation focused on measuring aphasia, post stroke
Eligibility 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
Sites / Locations
- Alexandria Main University Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
group I
group II
Arm Description
patients who received rehabilitation using the software program for aphasia rehabilitation
patients who received rehabilitation using the conventional therapy
Outcomes
Primary Outcome Measures
The primary outcome was a measure of improvement in language abilities.
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04717180
First Posted
January 2, 2021
Last Updated
January 19, 2021
Sponsor
Alexandria University
1. Study Identification
Unique Protocol Identification Number
NCT04717180
Brief Title
Post Stroke Aphasia Rehabilitation Using Computer-based Arabic Software Program: A Randomized Control Trial
Acronym
aphasia
Official Title
Post Stroke Aphasia Rehabilitation Using Computer-based Arabic Software Program: A Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
September 15, 2019 (Actual)
Study Completion Date
June 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia Rehabilitation
Keywords
aphasia, post stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group I
Arm Type
Active Comparator
Arm Description
patients who received rehabilitation using the software program for aphasia rehabilitation
Arm Title
group II
Arm Type
Active Comparator
Arm Description
patients who received rehabilitation using the conventional therapy
Intervention Type
Behavioral
Intervention Name(s)
aphasia rehabilitation using software program or conventional therapy
Other Intervention Name(s)
aphasia rehabilitation using the conventional language therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
The primary outcome was a measure of improvement in language abilities.
Description
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
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Alexandria Main University Hospitals
City
Alexandria
ZIP/Postal Code
21131
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Post Stroke Aphasia Rehabilitation Using Computer-based Arabic Software Program: A Randomized Control Trial
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