Upper Extremity Dysfunction After the StrokeNCT02013999
The Development of Upper Extremity Rehabilitation Program Using Virtual Reality for the Stroke Patients
A study testing Virtual reality program for upper extremity rehabilitation and standard occupational therapy in people with Upper Extremity Dysfunction After the Stroke, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Using the upper extremity rehabilitation program developed by virtual reality would help the recovery upper extremity function in patients with stroke. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Upper Extremity Dysfunction After the Stroke
- What is being tested?
- Virtual reality program for upper extremity rehabilitation and standard occupational therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2013to 24 Nov 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
- ischemic or hemorrhagic stroke confirmed by brain imaging study
- upper extremity dysfunction
- possible to use a simple device
Who cannot join
- delirium, confusion or other evidence related to the consciousness
- uncontrolled medical or surgical disease
- unable to command to the order due to severe cognitive impairment
- visual impairment
- unable to sit
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: Mobile Game-based Virtual Reality Rehabilitation Program for Upper Limb Dysfunction After Ischemic Stroke
Using the upper extremity rehabilitation program developed by virtual reality would help the recovery upper extremity function in patients with stroke.
Read the detailed description
This randomized, double-blind, controlled trial included 24 patients with ischemic stroke. The intervention group received 30 min of conventional occupational therapy (OT) and 30 min of the mobile upper extremity rehabilitation program using a smartphone and a tablet PC (MoU-Rehab). The controls (n = 12) received conventional OT alone for 1 h per day. Rehabilitation consisted of 10 sessions of therapy, 5 days per week, for 2 weeks. The outcome measures (Fugl-Meyer Assessment of the upper extremity [FMA-UE], Brunnstr¨om stage [B-stage] for the arm and the hand, manual muscle testing [MMT], modified Barthel index [MBI], EuroQol-5 Dimension [EQ-5D], and Beck Depression Inventory [BDI]) were assessed at the beginning and end of treatment, and at 1 month. User satisfaction was evaluated by a qestionnaire.
- Being tested
- Virtual reality program for upper extremity rehabilitation, standard occupational therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality program for upper extremity rehabilitationOther
standard occupational therapyOther
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality program | Experimental | mobile device for virtual reality program Receives: Other: Virtual reality program for upper extremity rehabilitation |
| Control | Active comparator | standard occupuational therapy Receives: Other: standard occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer upper extremity scale
for motor evaluation
Measured: baseline(just before beginning the treatment), at the end of the treatment for 2 weeks, 1 month later of the end of the treatment for 2 weeks
Secondary outcomes (6)
brunnström stage
for motor evaluation
Measured: baseline(just before beginning the treatment), at the end of the treatment for 2 weeks, 1 month later of the end of the treatment for 2 weeks
Modified Barthel Index
for ADL independence
Measured: baseline(just before beginning the treatment), at the end of the treatment for 2 weeks, 1 month later of the end of the treatment for 2 weeks
Medical Research Council (MRC) Scale for Muscle Strength
for motor evaluation
Measured: baseline(just before beginning the treatment), at the end of the treatment for 2 weeks, 1 month later of the end of the treatment for 2 weeks
Euroqol(EQ)-5D
EQ-5D
Measured: baseline(just before beginning the treatment), at the end of the treatment for 2 weeks, 1 month later of the end of the treatment for 2 weeks
Virtual reality kinematic data
Automatically recorded
Measured: everytime when the patient uses program (automatically all recorded)
questionnaire
for user satisfaction
Measured: at the end of the treatment for 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study startOct 2013
- Primary completion24 Nov 2014
- Study completion24 Nov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Extremity Dysfunction After the StrokeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nam-Jong Paik, Seoul National University Bundang Hospital
- Investigators
- Nam-Jong Paik, Ph.D, Principal investigator, Seoul National University Bundang Hospital, Seongnam, South Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013999
- Sponsor's protocol ID
- B-1306/208-005
- Status last verified
- Jan 2018
- First submitted
- 3 Dec 2013
- Last updated
- 30 Jan 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Game-based Virtual Reality Rehabilitation Program for Upper Limb Dysfunction After Ischemic Stroke
- ClinicalTrials.gov ID
- NCT02013999
- Acronym / sponsor ID
- B-1306/208-005
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- 24 Nov 2014 (actual)
- Study completion
- 24 Nov 2014 (actual)
- First posted
- 17 Dec 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.
Using the upper extremity rehabilitation program developed by virtual reality would help the recovery upper extremity function in patients with stroke.
Detailed description
This randomized, double-blind, controlled trial included 24 patients with ischemic stroke. The intervention group received 30 min of conventional occupational therapy (OT) and 30 min of the mobile upper extremity rehabilitation program using a smartphone and a tablet PC (MoU-Rehab). The controls (n = 12) received conventional OT alone for 1 h per day. Rehabilitation consisted of 10 sessions of therapy, 5 days per week, for 2 weeks. The outcome measures (Fugl-Meyer Assessment of the upper extremity [FMA-UE], Brunnstr¨om stage [B-stage] for the arm and the hand, manual muscle testing [MMT], modified Barthel index [MBI], EuroQol-5 Dimension [EQ-5D], and Beck Depression Inventory [BDI]) were assessed at the beginning and end of treatment, and at 1 month. User satisfaction was evaluated by a qestionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality program | Experimental | Other: Virtual reality program for upper extremity rehabilitationmobile device for virtual reality program |
| Control | Active comparator | Other: standard occupational therapystandard occupuational therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- ischemic or hemorrhagic stroke confirmed by brain imaging study
- upper extremity dysfunction
- possible to use a simple device
Key exclusion criteria (5 listed)
- delirium, confusion or other evidence related to the consciousness
- uncontrolled medical or surgical disease
- unable to command to the order due to severe cognitive impairment
- visual impairment
- unable to sit
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 |
|---|---|---|
| Virtual reality program for upper extremity rehabilitation | Other | Virtual reality program |
| standard occupational therapy | Other | Control |
Primary outcome
Fugl-Meyer upper extremity scale
Time frame: baseline(just before beginning the treatment), at the end of the treatment for 2 weeks, 1 month later of the end of the treatment for 2 weeks
for motor evaluation
6 secondary outcomes
brunnström stage
Time frame: baseline(just before beginning the treatment), at the end of the treatment for 2 weeks, 1 month later of the end of the treatment for 2 weeks
Modified Barthel Index
Time frame: baseline(just before beginning the treatment), at the end of the treatment for 2 weeks, 1 month later of the end of the treatment for 2 weeks
Medical Research Council (MRC) Scale for Muscle Strength
Time frame: baseline(just before beginning the treatment), at the end of the treatment for 2 weeks, 1 month later of the end of the treatment for 2 weeks
Euroqol(EQ)-5D
Time frame: baseline(just before beginning the treatment), at the end of the treatment for 2 weeks, 1 month later of the end of the treatment for 2 weeks
Virtual reality kinematic data
Time frame: everytime when the patient uses program (automatically all recorded)
questionnaire
Time frame: at the end of the treatment for 2 weeks
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 30 Jan 2018.
Related trials for Upper Extremity Dysfunction After the Stroke
Not yet recruiting
Spinal Cord Stimulation Combined With Motor Imagery Brain-Computer Interface for Chronic Post-Stroke Upper Limb Motor Dysfunction
Chronic Stroke
Not yet recruiting
Individualized rTMS Synchronized Task Training for Closed-loop Neuromodulation of Post-stroke Motor Dysfunction
Upper Extremity Dysfunction After the Stroke
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, Ph.D principal investigator
Seoul National University Bundang Hospital, Seongnam, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality program for upper extremity rehabilitation and standard occupational therapy in people with Upper Extremity Dysfunction After the 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 30 Jan 2018. 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: baseline(just before beginning the treatment), at the end of the treatment for 2 weeks, 1 month later of the end of the treatment for 2 weeks). 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 30 Jan 2018.