StrokeNCT05193539
Effects of Comprehensive Augmented and Virtual Reality in Stroke Patients
A study testing Augmented reality and virtual reality rehabilitation and Conventional occupational therapy in people with Stroke, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study was to assess the efficacy of augmented and virtual reality-based rehabilitation programs on improving upper extremity function in subacute stroke patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- Augmented reality and virtual reality rehabilitation and Conventional occupational therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Nov 2018to 21 Oct 2019
- 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
- First ever stroke
- Onset of stroke less than 3 months
- Sufficiently medically stable to participate in active rehabilitation
- Mild-to-moderate upper extremity motor impairments (Brunnstrom stage for the upper extremity 2-6).
Who cannot join
- Severe cognitive impairment (defined as score < 10 on the Mini-Mental State Examination)
- Evidence of apraxia
- Clinical history of neglect
- Previous upper extremity hemiplegia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Comprehensive Augmented and Virtual Reality for Upper Limb Rehabilitation in First-Ever Stroke Patients
The purpose of this study was to assess the efficacy of augmented and virtual reality-based rehabilitation programs on improving upper extremity function in subacute stroke patients.
Read the detailed description
This was a randomized, single-blinded study, conducted at a single acute rehabilitation unit in a university hospital. In this study, the effect of augmented and virtual reality-based rehabilitation for the recovery of subacute stroke patients compared with conventional occupational therapy was evaluated.
- Conditions
- Stroke
- Being tested
- Augmented reality and virtual reality rehabilitation, Conventional occupational therapy
- Keywords
- Virtual Reality, Augmented Reality
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented reality and virtual reality rehabilitationBehavioural
This group underwent augmented reality and virtual reality rehabilitation with 4 different systems.
The RAPAEL Smart Glove® is a wearable sensory system that contains a single 9-axis movement and position sensor with 3 acceleration channels, 3 angular rate channels, and 3 magnetic field channels that measures wrist movements, and 5 bending sensors that measure finger movements. The RAPAEL Smart Board® is a rehabilitation system used to improve arm function by practicing gravity-compensated movements. The RehabMaster® is a game-based Kinect sensor AR rehabilitation system which uses a 3D camera to digitize patient movements and quickly analyze their range of motion, speed, motion angle, and movement cycles. rehabilitation exercise using games to encourage active arm and trunk movements and promote successful rehabilitation. The COG-Trainer® is a VR system that uses a training device synchronized with the screen through simulation.
Conventional occupational therapyBehavioural
The group underwent standard ocupational therapy, such as range of motion and strengthening exercises for the affected upper extremity, table-top activities, and training for activities of daily living.
| Study group | Role | What they receive |
|---|---|---|
| Augmented reality and virtual reality rehabilitation | Experimental | This group underwent augmented reality and virtual reality rehabilitation for 60 minutes per session, 5 days per week for 2 weeks. Receives: Behavioral: Augmented reality and virtual reality rehabilitation |
| Conventional occupational therapy | Active comparator | This group underwent conventional occutational therapy for 60 minutes per session, 5 days per week for 2 weeks. Receives: Behavioral: Conventional occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment for Upper Extremity score
range (0-126), higher scores mean a better motor function
Measured: Baseline
Fugl-Meyer Assessment for Upper Extremity score
range (0-126), higher scores mean a better motor function
Measured: 2 weeks after intervention
Secondary outcomes (14)
Box and Block Test
higher scores mean a worse motor function
Measured: Baseline
Box and Block Test
higher scores mean a worse motor function
Measured: 2 weeks after intervention
Modified Barthel Index
range (0-100), higher scores mean a better activity of daily living
Measured: Baseline
Modified Barthel Index
range (0-100), higher scores mean a better activity of daily living
Measured: 2 weeks after intervention
Motor Activity Log of Amount of Use and Quality of Movement
range (0-150), higher scores mean a better activity of daily living
Measured: Baseline
Motor Activity Log of Amount of Use and Quality of Movement
range (0-150), higher scores mean a better activity of daily living
Measured: 2 weeks after intervention
EuroQol Visual Analogue Scale
range (0-100), higher scores mean a better quality of life
Measured: Baseline
EuroQol Visual Analogue Scale
range (0-100), higher scores mean a better quality of life
Measured: 2 weeks after intervention
Berg Balance Scale
range (0-56), higher scores mean a better balance function
Measured: Baseline
Berg Balance Scale
range (0-56), higher scores mean a better balance function
Measured: 2 weeks after intervention
Grip strength (kg)
higher scores mean a better hand function
Measured: Baseline
Grip strength (kg)
higher scores mean a better hand function
Measured: 2 weeks after intervention
Hand response reaction time
higher scores mean a worse hand function
Measured: Baseline
Hand response reaction time
higher scores mean a worse hand function
Measured: 2 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start19 Nov 2018
- Primary completion3 Dec 2018
- Study completion21 Oct 2019
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 Samsung Medical CenterThe 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
- Model description
- A randomized, single-blinded study. Individuals were randomly assigned to either the experimental group or control group using a computer-generated randomization technique. The randomization list was created on blocks of four and generated at the start of the study using a computerized program.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Geol Do, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193539
- Sponsor's protocol ID
- 2016-07-012-021
- Status last verified
- Jan 2022
- First submitted
- 9 Dec 2021
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Comprehensive Augmented and Virtual Reality for Upper Limb Rehabilitation in First-Ever Stroke Patients
- ClinicalTrials.gov ID
- NCT05193539
- Acronym / sponsor ID
- 2016-07-012-021
- Conditions
- Stroke
- Keywords
- Virtual Reality, Augmented Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- 3 Dec 2018 (actual)
- Study completion
- 21 Oct 2019 (actual)
- First posted
- 18 Jan 2022 (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.
The purpose of this study was to assess the efficacy of augmented and virtual reality-based rehabilitation programs on improving upper extremity function in subacute stroke patients.
Detailed description
This was a randomized, single-blinded study, conducted at a single acute rehabilitation unit in a university hospital. In this study, the effect of augmented and virtual reality-based rehabilitation for the recovery of subacute stroke patients compared with conventional occupational therapy was evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, single-blinded study. Individuals were randomly assigned to either the experimental group or control group using a computer-generated randomization technique. The randomization list was created on blocks of four and generated at the start of the study using a computerized program.
| Arm | Type | Receives |
|---|---|---|
| Augmented reality and virtual reality rehabilitation | Experimental | Behavioral: Augmented reality and virtual reality rehabilitationThis group underwent augmented reality and virtual reality rehabilitation for 60 minutes per session, 5 days per week for 2 weeks. |
| Conventional occupational therapy | Active comparator | Behavioral: Conventional occupational therapyThis group underwent conventional occutational therapy for 60 minutes per session, 5 days per week for 2 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- First ever stroke
- Onset of stroke less than 3 months
- Sufficiently medically stable to participate in active rehabilitation
- Mild-to-moderate upper extremity motor impairments (Brunnstrom stage for the upper extremity 2-6).
Key exclusion criteria (4 listed)
- Severe cognitive impairment (defined as score < 10 on the Mini-Mental State Examination)
- Evidence of apraxia
- Clinical history of neglect
- Previous upper extremity hemiplegia.
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 |
|---|---|---|
| Augmented reality and virtual reality rehabilitationThis group underwent augmented reality and virtual reality rehabilitation with 4 different systems. The RAPAEL Smart Glove® is a wearable sensory system that contains a single 9-axis movement and position sensor with 3 acceleration channels, 3 angular rate channels, and 3 magnetic field channels that measures wrist movements, and 5 bending sensors that measure finger movements. The RAPAEL Smart Board® is a rehabilitation system used to improve arm function by practicing gravity-compensated movements. The RehabMaster® is a game-based Kinect sensor AR rehabilitation system which uses a 3D camera to digitize patient movements and quickly analyze their range of motion, speed, motion angle, and movement cycles. rehabilitation exercise using games to encourage active arm and trunk movements and promote successful rehabilitation. The COG-Trainer® is a VR system that uses a training device synchronized with the screen through simulation. | Behavioural | Augmented reality and virtual reality rehabilitation |
| Conventional occupational therapyThe group underwent standard ocupational therapy, such as range of motion and strengthening exercises for the affected upper extremity, table-top activities, and training for activities of daily living. | Behavioural | Conventional occupational therapy |
Primary outcome
Fugl-Meyer Assessment for Upper Extremity score
Time frame: Baseline
range (0-126), higher scores mean a better motor function
Fugl-Meyer Assessment for Upper Extremity score
Time frame: 2 weeks after intervention
range (0-126), higher scores mean a better motor function
14 secondary outcomes
Box and Block Test
Time frame: Baseline
Box and Block Test
Time frame: 2 weeks after intervention
Modified Barthel Index
Time frame: Baseline
Modified Barthel Index
Time frame: 2 weeks after intervention
Motor Activity Log of Amount of Use and Quality of Movement
Time frame: Baseline
Motor Activity Log of Amount of Use and Quality of Movement
Time frame: 2 weeks after intervention
EuroQol Visual Analogue Scale
Time frame: Baseline
EuroQol Visual Analogue Scale
Time frame: 2 weeks after intervention
Berg Balance Scale
Time frame: Baseline
Berg Balance Scale
Time frame: 2 weeks after intervention
Grip strength (kg)
Time frame: Baseline
Grip strength (kg)
Time frame: 2 weeks after intervention
Hand response reaction time
Time frame: Baseline
Hand response reaction time
Time frame: 2 weeks after intervention
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 7 Feb 2022.
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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 Augmented reality and virtual reality rehabilitation and Conventional occupational therapy in people with Stroke, run by Samsung Medical Center 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 4 inclusion and 4 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 7 Feb 2022. 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 Assessment for Upper Extremity score (time frame: Baseline). 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 7 Feb 2022.