StrokeNCT01815905
Effect of U-Health Service in Stroke Patients
A study testing Mobile program for occupational and speech therapy and Traditional rehabilitation therapy in people with Stroke, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Provides mobile programs for occupational and speech therapy to patients with stroke. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- Mobile program for occupational and speech therapy and Traditional rehabilitation therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2013to Feb 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- stroke confirmed by brain imaging study
- Impairment in upper extremity function or speech
- native speaker of Korean
Who cannot join
- previous history of aphasia
- psychiatric or psychotic problem
- severe cognitive dysfunction
- severe hearing or visual loss
- cannot sit with devices
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Bundang-gu, 463-707
About this study
Official title: U-Health Service Using Mobile Device for Improvement of Post-Stroke Upper Limb Function and Aphasia
Provides mobile programs for occupational and speech therapy to patients with stroke.
- Conditions
- Stroke
- Being tested
- Mobile program for occupational and speech therapy, Traditional rehabilitation therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile program for occupational and speech therapyOther
Traditional rehabilitation therapyOther
| Study group | Role | What they receive |
|---|---|---|
| Traditional therapy | Active comparator | Traditional rehabilitation therapy Receives: Other: Traditional rehabilitation therapy |
| Mobile program | Experimental | Mobile program for occupational and speech therapy Receives: Other: Mobile program for occupational and speech therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer upper extremity scale
upper extremity function test
Measured: 4weeks
short form K-FAST (Korean version of Frenchay Aphasia Screening)
speech function screening test
Measured: 4weeks
Secondary outcomes (2)
Hand grip strength
hand power measurement
Measured: 4weeks
K-WAB(Korean version-the Western Aphasia Battery)
speech evaluation
Measured: 4weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- KT Corporation
- Responsible party
- Principal investigator, Nam-Jong Paik, Seoul National University Bundang Hospital
- Investigators
- Nam-Jong Paik, PhD, Study chair, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01815905
- Sponsor's protocol ID
- B-1206/160-005
- Status last verified
- Mar 2014
- First submitted
- 11 Mar 2013
- Last updated
- 5 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- U-Health Service Using Mobile Device for Improvement of Post-Stroke Upper Limb Function and Aphasia
- ClinicalTrials.gov ID
- NCT01815905
- Acronym / sponsor ID
- B-1206/160-005
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- KT Corporation
- Study start
- Mar 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 21 Mar 2013 (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.
Provides mobile programs for occupational and speech therapy to patients with stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional therapy | Active comparator | Other: Traditional rehabilitation therapyTraditional rehabilitation therapy |
| Mobile program | Experimental | Other: Mobile program for occupational and speech therapyMobile program for occupational and speech therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- stroke confirmed by brain imaging study
- Impairment in upper extremity function or speech
- native speaker of Korean
Key exclusion criteria (5 listed)
- previous history of aphasia
- psychiatric or psychotic problem
- severe cognitive dysfunction
- severe hearing or visual loss
- cannot sit with devices
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 |
|---|---|---|
| Mobile program for occupational and speech therapy | Other | Mobile program |
| Traditional rehabilitation therapy | Other | Traditional therapy |
Primary outcome
Fugl-Meyer upper extremity scale
Time frame: 4weeks
upper extremity function test
short form K-FAST (Korean version of Frenchay Aphasia Screening)
Time frame: 4weeks
speech function screening test
2 secondary outcomes
Hand grip strength
Time frame: 4weeks
K-WAB(Korean version-the Western Aphasia Battery)
Time frame: 4weeks
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 5 Mar 2014.
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
Nam-Jong Paik, PhD study chair
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile program for occupational and speech therapy and Traditional rehabilitation therapy in people with Stroke, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 3 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 5 Mar 2014. 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 South Korea. 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?
Fugl-Meyer upper extremity scale (time frame: 4weeks). The study lists 2 primary outcomes in all. 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 5 Mar 2014.