Aphasia RehabilitationaphasiaNCT04717180
Post Stroke Aphasia Rehabilitation Using Computer-based Arabic Software Program: A Randomized Control Trial
A study testing aphasia rehabilitation using software program or conventional therapy in people with Aphasia Rehabilitation, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aphasia Rehabilitation
- What is being tested?
- aphasia rehabilitation using software program or conventional therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 20 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of aphasia
- Age 18 years or more
Who cannot join
- Intellectual disabilities.
- Visual impairment.
- Hearing impairment.
- Associated dysarthria and or apraxia of speech.
- Associated psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Aphasia Rehabilitation
- Being tested
- aphasia rehabilitation using software program or conventional therapy
- Keywords
- aphasia, post stroke
- Medical subject headings
- Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aphasia rehabilitation using software program or conventional therapyBehavioural
Also called aphasia rehabilitation using the conventional language 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
| Study group | Role | What they receive |
|---|---|---|
| group I | Active comparator | patients who received rehabilitation using the software program for aphasia rehabilitation Receives: Behavioral: aphasia rehabilitation using software program or conventional therapy |
| group II | Active comparator | patients who received rehabilitation using the conventional therapy Receives: Behavioral: aphasia rehabilitation using software program or conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Jan 2018
- Primary completion15 Sep 2019
- Study completion20 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aphasia RehabilitationStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717180
- Sponsor's protocol ID
- aphasia software
- Acronym
- aphasia
- Status last verified
- Dec 2020
- First submitted
- 2 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Stroke Aphasia Rehabilitation Using Computer-based Arabic Software Program: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04717180
- Acronym / sponsor ID
- aphasia / aphasia software
- Conditions
- Aphasia Rehabilitation
- Keywords
- aphasia, post stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 15 Sep 2019 (actual)
- Study completion
- 20 Jun 2020 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group I | Active comparator | Behavioral: aphasia rehabilitation using software program or conventional therapypatients who received rehabilitation using the software program for aphasia rehabilitation |
| group II | Active comparator | Behavioral: aphasia rehabilitation using software program or conventional therapypatients who received rehabilitation using the conventional therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of aphasia
- Age 18 years or more
Key exclusion criteria (5 listed)
- Intellectual disabilities.
- Visual impairment.
- Hearing impairment.
- Associated dysarthria and or apraxia of speech.
- Associated psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aphasia rehabilitation using software program or conventional therapyAlso: aphasia rehabilitation using the conventional language therapyPatients 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 | Behavioural | group I, group II |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aphasia rehabilitation using software program or conventional therapy in people with Aphasia Rehabilitation, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome was a measure of improvement in language abilities. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.