search
Back to results

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
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia Rehabilitation focused on measuring aphasia, post stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
January 2, 2021
Last Updated
January 19, 2021
Sponsor
Alexandria University
search

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

We'll reach out to this number within 24 hrs