StrokeNCT03750526
Effectiveness of Augmented Reality and Repetitive Transcranial Magnetic Stimulation
A study testing rTMS and AR, AR and Conventional physiotherapy in people with Stroke, run by Taipei Medical University Hospital at 1 site in Taiwan.
Trial summary
This study is to investigate the combined effects of repetitive Transcranial Magnetic Stimulation (rTMS) and Augmented Reality (AR) intervention on cortical excitability, balance, gait, activity in individuals with stroke. Forty 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?
- rTMS and AR, AR and Conventional physiotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Jul 2018to 30 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
- Cognitive ability is sufficient to understand the nature of study (Mini-Mental State Examination score was above 23).
- Participants suffer from unilateral hemiplegia caused by a first-ever stroke.
- Participants are stable in medical and psychological condition.
Who cannot join
- Participants have other neurologic problems that can affect balance and walking ability.
- Participants take of drugs or have other medical condition that can affect balance and function.
- Participants have contraindications for rTMS intervention such as pacemaker, cochlear implants, metal in the brain or skull, open wound of brain, or history of epilepsy.
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: Investigate the Effectiveness of Augmented Reality and Repetitive Transcranial Magnetic Stimulation Technology in Persons With Stroke
This study is to investigate the combined effects of repetitive Transcranial Magnetic Stimulation (rTMS) and Augmented Reality (AR) intervention on cortical excitability, balance, gait, activity in individuals with stroke. Forty participants will be recruited in this study. They will be allocated to four group: rTMS and AR group (10), sham rTMS and AR group (10), AR group (10), and conventional physiotherapy group (10).
Read the detailed description
Participants will be randomized allocated to four groups: rTMS and AR group, sham rTMS and AR group, AR group ,and conventional physiotherapy group in current study. All participants underwent four weeks, 3 sessions per week, and 60 minutes per session training program. Motor evoked potential (MEP), Time up go test (TUG), Berg Balance Scale (BBS), Fugl-Meyer Assessment (FMA), Multi-directional Reach Test (MDRT),The Postural Assessment Scale for Stroke Patients (PASS), and Taiwanese Depression Questionnaires (TDQ) will be assessed before and after intervention in all participants.
- Conditions
- Stroke
- Being tested
- rTMS and AR, Sham rTMS and AR, AR, Conventional physiotherapy
- Keywords
- Repetitive transcranial magnetic stimulation (rTMS), Augmented reality (AR), stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMS and ARBehavioural
rTMS performs 1Hz,15 minutes real rTMS. AR intervention contains weight-shift exercise, strengthening of lower limb and balance training for 45 minutes.
Sham rTMS and ARBehavioural
Sham rTMS applies 1Hz, 15 minutes sham rTMS. AR intervention includes weight-shift exercise, strengthening of lower limb and balance training for 45 minutes.
ARBehavioural
AR intervention contains weight-shift exercise, strengthening of lower limb and balance training for 60 minutes.
Conventional physiotherapyBehavioural
Conventional physiotherapy includes rolling, sitting, balance exercise, standing, overground walking, facilitation of the paretic limbs, and so on for 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| rTMS and AR group | Experimental | Ten participants in group A will undergo repetitive transcranial magnetic stimulation (real, 1 Hz, 15 minutes), follow by a session of augmented reality exercise (45 minutes), 3 days per week for 4 weeks. Receives: Behavioral: rTMS and AR |
| Sham rTMS and AR group | Active comparator | Ten participants in group B will receive repetitive transcranial magnetic stimulation (sham,1 Hz, 15 minutes), follow by a session of augmented reality exercise (45 minutes), 3 days per week for 4 weeks. Receives: Behavioral: Sham rTMS and AR |
| AR group | Active comparator | Ten participants in group C will undergo augmented reality exercise 60 minutes a day and 3 days per week for four weeks. Receives: Behavioral: AR |
| Conventional physiotherapy group | Active comparator | Ten participants allocated to the group D will receive conventional physiotherapy 60 minutes a day and 3 days per week for four weeks. Receives: Behavioral: Conventional 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 m, 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 4) in four groups
Secondary outcomes (6)
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 4) in four 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 4) in four groups
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 4) in four groups
Change of Multi-directional Reach Test (MDRT)
Participants will be required to reach in the forward, left and right directions. The test is performed with the participant in standing. It is the measure of the difference, in centimeters, between arm's length with arms at 90° flexion/ abduction and maximal forward, left and right directions reaching respectively, using a fixed base of support. The test uses a centimeters measuring device against a wall at shoulder height.
Measured: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
Change of The Postural Assessment Scale for Stroke Patients (PASS)
The Postural Assessment Scale for Stroke Patients (PASS) is a postural assessment scale specifically designed to assess and monitor postural control after stroke. It contains 12 four-level items of varying difficulty for assessing ability to maintain or change a given lying, sitting, or standing posture. The PASS consists of 2 sections with a 4-point scale to describe each task. The total score ranges from 0 - 36. A score of 0 denotes the inability of the participant to perform the task, and a score of 3 denotes that the participant can complete the task based on a preset criterion. The highest possible score is 36.
Measured: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
Change of Taiwanese Depression Questionnaires (TDQ)
Taiwanese Depression Questionnaires (TDQ) contains 18 items to screen the situation of depression within a week. The TDQ, which is a 4-point scale with 18 items, is a culturally specific depression self-rating instrument for effective screening of depression in Taiwan and has satisfactory reliability and validity. Subjects are guided to rate each item on a scale from 0 to 3 on the basis of "how often you felt the physical and emotional aspects during the past week". Zero denotes never, three means always. TDQ scores range from 0 to 54.
Measured: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start31 Jul 2018
- Primary completion30 Oct 2023 (estimated)
- Study completion30 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
- 40 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
- Investigators
- Chien-Hung Lai, MD PhD, Principal investigator, Taipei Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750526
- Sponsor's protocol ID
- N201703084
- Status last verified
- Jan 2023
- First submitted
- 20 Nov 2018
- 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
- Investigate the Effectiveness of Augmented Reality and Repetitive Transcranial Magnetic Stimulation Technology in Persons With Stroke
- ClinicalTrials.gov ID
- NCT03750526
- Acronym / sponsor ID
- N201703084
- Conditions
- Stroke
- Keywords
- Repetitive transcranial magnetic stimulation (rTMS), Augmented reality (AR), stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Taipei Medical University HospitalUniversity, hospital or other
- Study start
- 31 Jul 2018 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 23 Nov 2018 (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 combined effects of repetitive Transcranial Magnetic Stimulation (rTMS) and Augmented Reality (AR) intervention on cortical excitability, balance, gait, activity in individuals with stroke. Forty participants will be recruited in this study. They will be allocated to four group: rTMS and AR group (10), sham rTMS and AR group (10), AR group (10), and conventional physiotherapy group (10).
Detailed description
Participants will be randomized allocated to four groups: rTMS and AR group, sham rTMS and AR group, AR group ,and conventional physiotherapy group in current study. All participants underwent four weeks, 3 sessions per week, and 60 minutes per session training program. Motor evoked potential (MEP), Time up go test (TUG), Berg Balance Scale (BBS), Fugl-Meyer Assessment (FMA), Multi-directional Reach Test (MDRT),The Postural Assessment Scale for Stroke Patients (PASS), and Taiwanese Depression Questionnaires (TDQ) 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
- 4
| Arm | Type | Receives |
|---|---|---|
| rTMS and AR group | Experimental | Behavioral: rTMS and ARTen participants in group A will undergo repetitive transcranial magnetic stimulation (real, 1 Hz, 15 minutes), follow by a session of augmented reality exercise (45 minutes), 3 days per week for 4 weeks. |
| Sham rTMS and AR group | Active comparator | Behavioral: Sham rTMS and ARTen participants in group B will receive repetitive transcranial magnetic stimulation (sham,1 Hz, 15 minutes), follow by a session of augmented reality exercise (45 minutes), 3 days per week for 4 weeks. |
| AR group | Active comparator | Behavioral: ARTen participants in group C will undergo augmented reality exercise 60 minutes a day and 3 days per week for four weeks. |
| Conventional physiotherapy group | Active comparator | Behavioral: Conventional physiotherapyTen participants allocated to the group D will receive conventional physiotherapy 60 minutes a day and 3 days per week for four 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)
- Cognitive ability is sufficient to understand the nature of study (Mini-Mental State Examination score was above 23).
- Participants suffer from unilateral hemiplegia caused by a first-ever stroke.
- Participants are stable in medical and psychological condition.
Key exclusion criteria (3 listed)
- Participants have other neurologic problems that can affect balance and walking ability.
- Participants take of drugs or have other medical condition that can affect balance and function.
- Participants have contraindications for rTMS intervention such as pacemaker, cochlear implants, metal in the brain or skull, open wound of brain, or history of epilepsy.
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 |
|---|---|---|
| rTMS and ARrTMS performs 1Hz,15 minutes real rTMS. AR intervention contains weight-shift exercise, strengthening of lower limb and balance training for 45 minutes. | Behavioural | rTMS and AR group |
| Sham rTMS and ARSham rTMS applies 1Hz, 15 minutes sham rTMS. AR intervention includes weight-shift exercise, strengthening of lower limb and balance training for 45 minutes. | Behavioural | Sham rTMS and AR group |
| ARAR intervention contains weight-shift exercise, strengthening of lower limb and balance training for 60 minutes. | Behavioural | AR group |
| Conventional physiotherapyConventional physiotherapy includes rolling, sitting, balance exercise, standing, overground walking, facilitation of the paretic limbs, and so on for 60 minutes. | Behavioural | Conventional 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 4) in four groups
The TUG test will ask participants to stand up, walk for 3 m, 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.
6 secondary outcomes
Change of Berg Balance Scale (BBS)
Time frame: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
Change of Motor evoked potential (MEP)
Time frame: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
Change of Fugl-Meyer Assessment (FMA)-Lower extremity
Time frame: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
Change of Multi-directional Reach Test (MDRT)
Time frame: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
Change of The Postural Assessment Scale for Stroke Patients (PASS)
Time frame: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
Change of Taiwanese Depression Questionnaires (TDQ)
Time frame: Measurement before and after intervention ( week 0 and at the end of week 4) in four 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.
Chien-Hung Lai, MD PhD principal investigator
Taipei Medical University 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 rTMS and AR, AR and Conventional 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 4) in four groups). 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.