AphasiaNCT02694133
Efficacy of Telerehabilitation in the Patients With Aphasia
A study testing Smart Phone Based Assistive Speech Therapeutic System and Mobile phone-based tele rehabilitation program in people with Aphasia, run by Kaohsiung Veterans General Hospital..
Trial summary
The study will invite 30 patients to join, and they will be arranged in the face to face group and telerehabilitation group randomly. In the telerehabilitation group, the investigators use the mobile device, which with the camera and speaker, for patients to practice the naming training at home, and assess the speech… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Aphasia
- What is being tested?
- Smart Phone Based Assistive Speech Therapeutic System and Mobile phone-based tele rehabilitation program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Dec 2012
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients diagnosed as aphasia
Who cannot join
- poor auditory comprehension
About this study
The study will invite 30 patients to join, and they will be arranged in the face to face group and telerehabilitation group randomly.
In the telerehabilitation group, the investigators use the mobile device, which with the camera and speaker, for patients to practice the naming training at home, and assess the speech ability every 2-4weeks by speech therapist via telerehabilitation platform.
Read more
Concise Chinese Aphasia Test (CCAT) and ASHA FACS conceptual framework Test will be used as the assessment tool for evaluation speech ability and functional ability.
The investigators expect that patients can improve their speech ability, functional ability, and quality of life via telerehabilitation speech therapy.
And the investigators can establish the standard telerehabilitation speech therapy protocol for aphasia therapy.
- Conditions
- Aphasia
- Being tested
- Smart Phone Based Assistive Speech Therapeutic System, Mobile phone-based tele rehabilitation program
- Keywords
- telerehabilitation, aphasia, speech therapy, rehabilitation device, visual action therapy, naming drills
- Medical subject headings
- Aphasia, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart Phone Based Assistive Speech Therapeutic SystemProcedure or surgery
use the mobile device, which with the camera and speaker, for patients to practice the naming training at home, and assess the speech ability every 2-4weeks by speech therapist via telerehabilitation platform. Concise Chinese Aphasia Test (CCAT) will be used as the assessment tool for evaluation speech ability and functional ability.
Mobile phone-based tele rehabilitation programProcedure or surgery
Mobile phone-based tele rehabilitation program
| Study group | Role | What they receive |
|---|---|---|
| Aphasia group | Experimental | Aphasia Receives: Procedure: Smart Phone Based Assistive Speech Therapeutic System; Procedure: Mobile phone-based tele rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concise Chinese Aphasia Test
Measured: monthly changes within 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startJan 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphasiaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Veterans General Hospital.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun-Han Yang, Kaohsiung Veterans General Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694133
- Sponsor's protocol ID
- VGHKS-CT11-06
- Status last verified
- Feb 2016
- First submitted
- 27 Dec 2011
- Last updated
- 29 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Telerehabilitation in the Patients With Aphasia
- ClinicalTrials.gov ID
- NCT02694133
- Acronym / sponsor ID
- VGHKS-CT11-06
- Conditions
- Aphasia
- Keywords
- telerehabilitation, aphasia, speech therapy, rehabilitation device, visual action therapy, naming drills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Kaohsiung Veterans General Hospital.University, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 29 Feb 2016 (estimated)
- 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.
The study will invite 30 patients to join, and they will be arranged in the face to face group and telerehabilitation group randomly.
In the telerehabilitation group, the investigators use the mobile device, which with the camera and speaker, for patients to practice the naming training at home, and assess the speech ability every 2-4weeks by speech therapist via telerehabilitation platform.
Concise Chinese Aphasia Test (CCAT) and ASHA FACS conceptual framework Test will be used as the assessment tool for evaluation speech ability and functional ability.
The investigators expect that patients can improve their speech ability, functional ability, and quality of life via telerehabilitation speech therapy.
And the investigators can establish the standard telerehabilitation speech therapy protocol for aphasia therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aphasia group | Experimental | Procedure: Smart Phone Based Assistive Speech Therapeutic System, Procedure: Mobile phone-based tele rehabilitation programAphasia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients diagnosed as aphasia
Key exclusion criteria (1 listed)
- poor auditory comprehension
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 |
|---|---|---|
| Smart Phone Based Assistive Speech Therapeutic Systemuse the mobile device, which with the camera and speaker, for patients to practice the naming training at home, and assess the speech ability every 2-4weeks by speech therapist via telerehabilitation platform. Concise Chinese Aphasia Test (CCAT) will be used as the assessment tool for evaluation speech ability and functional ability. | Procedure or surgery | Aphasia group |
| Mobile phone-based tele rehabilitation programMobile phone-based tele rehabilitation program | Procedure or surgery | Aphasia group |
Primary outcome
Concise Chinese Aphasia Test
Time frame: monthly changes within 3 months
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 29 Feb 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Smart Phone Based Assistive Speech Therapeutic System and Mobile phone-based tele rehabilitation program in people with Aphasia, run by Kaohsiung Veterans General Hospital..
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 1 inclusion and 1 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 29 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Concise Chinese Aphasia Test (time frame: monthly changes within 3 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 29 Feb 2016.