StrokeNCT04003571
Effectiveness of Interactive Augmented Reality and Electrical Neuromodulation System in Persons With Stroke
A study testing Augmented Reality with Functional Electrical Stimulation group and Traditional physiotherapy in people with Stroke, run by Taipei Medical University Hospital at 1 site in Taiwan.
Trial summary
This study is to investigate the effects of Augmented Reality (AR) combined with Functional Electrical Stimulation (FES) intervention on cortical excitability, brain structure, lower limbs function, balance, and spasticity in individuals with stroke. Twenty participants will be recruited in this study. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Augmented Reality with Functional Electrical Stimulation group and Traditional physiotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Oct 2019to 31 Dec 2023
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients present with unilateral hemiplegia caused by a first-ever stroke
- Brunnstrom stage above stage II, mental health was stable
- Cognitive ability is sufficient to understand the nature of study (Mini-Mental State Examination score was above 23)
Who cannot join
- Patients having other neurologic problems, which can affect balance and walking ability
- Intake of drugs or other medical condition that can affect function or can't tolerate rehabilitation
- severe hearing or eye problem
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical university Hospital
Taipei
Chien-Hung Lai, MD PhD
About this study
Official title: Development of Interactive Augmented Reality and Electrical Neuromodulation System to Improve Neuroplasticity and Limbs Function in Persons With Stroke
This study is to investigate the effects of Augmented Reality (AR) combined with Functional Electrical Stimulation (FES) intervention on cortical excitability, brain structure, lower limbs function, balance, and spasticity in individuals with stroke. Twenty participants will be recruited in this study. They will be allocated to two group: AR and FES group (10), Traditional physiotherapy group (10).
Read the detailed description
Participants will be randomized allocated to two groups: Augmented Reality and Functional Electrical Stimulation group , and traditional physiotherapy group. All participants will undergo 60 minutes per session, 3 sessions per week for 8 weeks training. Functional Magnetic Resonance Imaging (fMRI) with Diffusion Tensor Imaging (DTI), Time up go test (TUG), Berg Balance Scale (BBS), Fugl-Meyer Assessment (FMA), Modified Ashworth Scale (MAS), 10 meter walking test will be assessed before and after intervention in all participants.
- Conditions
- Stroke
- Being tested
- Augmented Reality with Functional Electrical Stimulation group, Traditional physiotherapy
- Keywords
- stroke, augmented reality, functional electrical stimulation
- 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 with Functional Electrical Stimulation groupBehavioural
Experimental group contains 30 minutes augmented reality combined with functional electrical stimulation training, and 30 minutes traditional physiotherapy. Augmented reality includes treadmill and balance exercise. Functional electrical stimulation applies on tibialis anterior muscle. Traditional physiotherapy includes rolling, sitting, standing, overground walking, facilitation of the paretic limbs, and so on.
Traditional physiotherapyBehavioural
Traditional physiotherapy includes treadmill and balance training for 30 minutes as well as rolling, sitting, standing, overground walking, facilitation of the paretic limbs for another 30 minutes .
| Study group | Role | What they receive |
|---|---|---|
| Augmented reality with functional electrical stimulation group | Experimental | Ten participants in group A will undergo 30 minutes interactive augmented reality with functional electrical stimulation intervention and 30 minutes traditional physiotherapy per day, 3 days a week for 8 weeks. Receives: Behavioral: Augmented Reality with Functional Electrical Stimulation group |
| Traditional physiotherapy group | Active comparator | Ten participants in group B will undergo 30 minutes treadmill and balance training as well as 30 minutes traditional conventional physiotherapy a day, 3 days a week, for 8 weeks. Receives: Behavioral: Traditional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Time Up Go test (TUG)
The TUG test will ask participants to stand up, walk for 3 meters, turn, walk back and sit down as fast as they can during the test, and the time requires for each patient to complete the test is recorded.
Measured: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
Change of Berg Balance Scale (BBS)
Participants performed a series of 14 functional balance tasks, including maintaining a quiet stance, sitting-to-standing, shifting weight and reaching, turning in place, standing on one leg, and maintaining a tandem stance. Each task was scored on a 5-point ordinal scale (from 0 to 4). A score of 0 denotes the inability of the participant to perform the task, and a score of 4 denotes that the participant can complete the task based on a preset criterion. The highest possible score is 56.
Measured: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
Change of Functional magnetic resonance imaging (fMRI)
Our study will use 3 Tesla magnetic resonance imaging[GE DISCOVERY MR750w system (GE Healthcare, Milwaukee, Wisconsin)] for functional magnetic resonance imaging. Resting-state functional MRI image is an echo-planar Image (EPI) technique, using a parameter time of repetition of 2500 milliseconds, time of echo is 30 milliseconds, 43 axial slices,slice thickness is 3 mm, flip angle is 80 degrees, field of view is 192 x 192 millimeters, and vixen size is 3 x 3 x 3 millimeters. The EPI scan for 525 seconds. All subjects are asked to close their eyes and supine. our study uses the fractional amplitude of low-frequency fluctuations analysis to confirm abnormal brain function.
Measured: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
Secondary outcomes (5)
Change of Fugl-Meyer Assessment (FMA)-Lower extremity
Fugl-Meyer Assessment-Lower extremity is used to measure lower-limb recovery in stroke rehabilitation studies.The scale has 6 items ranging from reflex activity to voluntary motor control. Each item further comprises components, with a total of 17. Scoring is done on a 3-point ordinal scale ranges from 0 (no performance) to 2 (faultless performance). The total score range from 0 (no motor function) to 34 (good motor recovery).
Measured: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
Change of Modified Ashworth Scale (MAS)
Modified Ashworth scale (MAS) measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. Scoring is recorded as follows:
0: No increase in muscle tone
- Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the Range of motion (ROM)
- More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
- Considerable increase in muscle tone, passive movement difficult
- Affected part(s) rigid in flexion or extension
Measured: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
Change of Motor evoked potential (MEP)
Motor evoked potential (MEP) is recorded from tibialis anterior muscles following direct transcranial magnetic stimulation (TMS) of motor cortex. All TMS is delivered with the participant seated upright on the chair. Both passive and active conditions, participants are instructed to relax their right leg in the seated position. TMS is delivered over the motor cortex (M1) using a concave double cone coil (Magstim Co., United Kingdom) attached to a BiStim magnetic stimulator (Magstim Co., United Kingdom). To locate the optimal site, stimuli are delivered over various points along the M1. The optimal site is the location on the M1 that evoked the greatest MEP amplitude in the bilateral tibialis anterior muscles. The onset latency and onset to peak amplitude will be assessed.
Measured: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
Change of 10 meter walking test
Individual walks without assistance 10 meters and the time is measured. Participants will walk 10 meter at preferred walking speed and fastest speed possible, respectively.
Measured: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
Change of Diffusion Tensor Imaging (DTI)
Diffusion tensor imaging technique apply to Echo-Planar Image(EPI) technique, fimbriodentate vein is 192X192 mm², time of repetition/time of echo is 11000/110.6 mm, matrix is 72X72 pixels, slice thickness is 2.7 mm. Diffusion weight gradient along 60 directions at b value of 3000/mm². By observing the reduction of the degree of diffusion anisotropy, to study the recovery of motor function after stroke.
Measured: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start10 Oct 2019
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
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.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lai chien hung, Taipei Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003571
- Sponsor's protocol ID
- N201904041
- Status last verified
- Jan 2023
- First submitted
- 27 Jun 2019
- Last updated
- 31 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Interactive Augmented Reality and Electrical Neuromodulation System to Improve Neuroplasticity and Limbs Function in Persons With Stroke
- ClinicalTrials.gov ID
- NCT04003571
- Acronym / sponsor ID
- N201904041
- Conditions
- Stroke
- Keywords
- stroke, augmented reality, functional electrical stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Taipei Medical University HospitalUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 1 Jul 2019 (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.
This study is to investigate the effects of Augmented Reality (AR) combined with Functional Electrical Stimulation (FES) intervention on cortical excitability, brain structure, lower limbs function, balance, and spasticity in individuals with stroke. Twenty participants will be recruited in this study. They will be allocated to two group: AR and FES group (10), Traditional physiotherapy group (10).
Detailed description
Participants will be randomized allocated to two groups: Augmented Reality and Functional Electrical Stimulation group , and traditional physiotherapy group. All participants will undergo 60 minutes per session, 3 sessions per week for 8 weeks training. Functional Magnetic Resonance Imaging (fMRI) with Diffusion Tensor Imaging (DTI), Time up go test (TUG), Berg Balance Scale (BBS), Fugl-Meyer Assessment (FMA), Modified Ashworth Scale (MAS), 10 meter walking test will be assessed before and after intervention in all participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Augmented reality with functional electrical stimulation group | Experimental | Behavioral: Augmented Reality with Functional Electrical Stimulation groupTen participants in group A will undergo 30 minutes interactive augmented reality with functional electrical stimulation intervention and 30 minutes traditional physiotherapy per day, 3 days a week for 8 weeks. |
| Traditional physiotherapy group | Active comparator | Behavioral: Traditional physiotherapyTen participants in group B will undergo 30 minutes treadmill and balance training as well as 30 minutes traditional conventional physiotherapy a day, 3 days a week, for 8 weeks. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients present with unilateral hemiplegia caused by a first-ever stroke
- Brunnstrom stage above stage II, mental health was stable
- Cognitive ability is sufficient to understand the nature of study (Mini-Mental State Examination score was above 23)
Key exclusion criteria (3 listed)
- Patients having other neurologic problems, which can affect balance and walking ability
- Intake of drugs or other medical condition that can affect function or can't tolerate rehabilitation
- severe hearing or eye problem
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 with Functional Electrical Stimulation groupExperimental group contains 30 minutes augmented reality combined with functional electrical stimulation training, and 30 minutes traditional physiotherapy. Augmented reality includes treadmill and balance exercise. Functional electrical stimulation applies on tibialis anterior muscle. Traditional physiotherapy includes rolling, sitting, standing, overground walking, facilitation of the paretic limbs, and so on. | Behavioural | Augmented reality with functional electrical stimulation group |
| Traditional physiotherapyTraditional physiotherapy includes treadmill and balance training for 30 minutes as well as rolling, sitting, standing, overground walking, facilitation of the paretic limbs for another 30 minutes . | Behavioural | Traditional physiotherapy group |
Primary outcome
Change of Time Up Go test (TUG)
Time frame: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
The TUG test will ask participants to stand up, walk for 3 meters, turn, walk back and sit down as fast as they can during the test, and the time requires for each patient to complete the test is recorded.
Change of Berg Balance Scale (BBS)
Time frame: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
Participants performed a series of 14 functional balance tasks, including maintaining a quiet stance, sitting-to-standing, shifting weight and reaching, turning in place, standing on one leg, and maintaining a tandem stance. Each task was scored on a 5-point ordinal scale (from 0 to 4). A score of 0 denotes the inability of the participant to perform the task, and a score of 4 denotes that the participant can complete the task based on a preset criterion. The highest possible score is 56.
Change of Functional magnetic resonance imaging (fMRI)
Time frame: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
Our study will use 3 Tesla magnetic resonance imaging[GE DISCOVERY MR750w system (GE Healthcare, Milwaukee, Wisconsin)] for functional magnetic resonance imaging. Resting-state functional MRI image is an echo-planar Image (EPI) technique, using a parameter time of repetition of 2500 milliseconds, time of echo is 30 milliseconds, 43 axial slices,slice thickness is 3 mm, flip angle is 80 degrees, field of view is 192 x 192 millimeters, and vixen size is 3 x 3 x 3 millimeters. The EPI scan for 525 seconds. All subjects are asked to close their eyes and supine. our study uses the fractional amplitude of low-frequency fluctuations analysis to confirm abnormal brain function.
5 secondary outcomes
Change of Fugl-Meyer Assessment (FMA)-Lower extremity
Time frame: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
Change of Modified Ashworth Scale (MAS)
Time frame: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
Change of Motor evoked potential (MEP)
Time frame: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
Change of 10 meter walking test
Time frame: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
Change of Diffusion Tensor Imaging (DTI)
Time frame: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
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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.
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 with Functional Electrical Stimulation group and Traditional physiotherapy in people with Stroke, run by Taipei Medical University Hospital at 1 site in Taiwan.
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 3 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: status not confirmed, as of the sponsor's last update on 31 Jan 2023. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chien-Hung Lai, MD PhD (886-2-27372181 ext. 3538, chlai@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Time Up Go test (TUG) (time frame: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups). The study lists 3 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 31 Jan 2023.