StrokeNCT04333758
Outpatient and Home Advanced Rehabilitation Therapeutics Using Jintronix Virtual Reality Telerehabilitation System
A study testing Jintronix Virtual Reality Telerehabilitation System in people with Stroke, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial summary
The use of virtual reality technology in a telerehabilitation service is not well established in Singapore. This feasibility trial aims to evaluate the benefits of using Jintronix to deliver a clinic-to-home, caregiver-supervised and individualised exercise telerehabilitation program to complement outpatient services… Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Jintronix Virtual Reality Telerehabilitation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSingapore
- Study dates
- 5 Jan 2017to 14 Nov 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with motor deficits due to stroke as diagnosed by CT or MRI, who are attending outpatient rehabilitation services at Tan Tock Seng Hospital Rehabilitation Centre and Centre for Advanced Rehabilitation Therapeutics
- post stroke of at least 3 months with stable neurological status
- 21-75 years old
- able to perform at minimal level of assistance (i.e. carer provides only up to 25% of physical support) for sitting, standing and/or walking tasks
- has a primary caregiver that must be present in all trial sessions
- able to understand and participate in a 15 minutes Jintronix trial during screening
Who cannot join
- has seizure history
- has severe cognitive deficits, perceptual deficits, and/or emotional-behavioural issues
- has unstable medical conditions which may affect participation (e.g unresolved sepsis, postural hypotension, end stage renal failure) or anticipated life expectancy of <1 year due to malignancy or neurodegenerative disorder
- has pain score of >5
- is pregnant or breastfeeding
- has known poor cardiac ejection fraction (<30%) or lung function (FEV1<30%)
- has non-weight bearing status in either lower extremities
- has caregiver who is unable to meet competency requirements as assessed by study team
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Centre for Advanced Rehabilitation Therapeutics, Tan Tock Seng Hospital
Singapore
About this study
The use of virtual reality technology in a telerehabilitation service is not well established in Singapore. This feasibility trial aims to evaluate the benefits of using Jintronix to deliver a clinic-to-home, caregiver-supervised and individualised exercise telerehabilitation program to complement outpatient services and improve clinical outcomes for post-stroke users.
Read the detailed description
With the emphasis on improving population health, reducing the need for hospital care, and promoting self-management, it will be beneficial to make good use of current available technologies to complement centre-based therapy with cost effectiveness and efficiency.
One mode of such care delivery to a patient's home is through a telerehabilitation system that enables remote monitoring of patients' participation and performance in individualised home exercises. In addition, timely review and adjustments in the home programs to cater to progress or changes in patients' performance can be carried out by therapists remotely.
In the recent years, there has been an increased utilisation of virtual reality applications in physical rehabilitation for specific training objectives, such as, movement retraining, balance control and strength training. Virtual reality exercises when prescribed with defined training objectives and duration can potentially be valuable to increase patients' training intensity in the comfort of their own homes.
The majority of patients receiving outpatient and home based rehabilitation at Tan Tock Seng Hospital (TTSH) Rehabilitation Centre (RC) and Centre for Advanced Rehabilitation Therapeutics (CART) are patients who have had a stroke. Hence this group of outpatients that are at least 3 months post-stroke will be recruited for this trial. It is hypothesized that they will benefit from increased intensity of upper limb, balance and/or gait rehabilitation with Jintronix telerehabilitation system that facilitates them to further exercise at home and not just at the clinic.
The study is thus designed to evaluate the feasibility of a novel telerehabilitation service based on the Jintronix Virtual Reality Platform to complement existing outpatient therapy services of TTSH RC (including its outpatient service arm at CART).
- Conditions
- Stroke
- Being tested
- Jintronix Virtual Reality Telerehabilitation System
- Keywords
- Rehabilitation, Telerehabilitation, Virtual Reality
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jintronix Virtual Reality Telerehabilitation SystemDevice
Also called Jintronix
System consists of an internet-based rehabilitation software linked to a Microsoft Kinect camera for motion detection.
Study team therapist prescribed a list of guided exercises and therapeutic activities (games) for training of whole body, lower and upper extremities. These can be done in sitting or standing, depending on individual participant's capacity.
Telemonitoring is done by study team therapist during each of the training day (Mondays-Fridays) of the home-based training phase. Training performance results are reviewed and training games are adjusted or changed to optimise home training.
| Study group | Role | What they receive |
|---|---|---|
| Jintronix Intervention | Experimental | 2 consecutive phases of intervention for all participants using Jintronix virtual reality telerehabilitation software.
Phase 1 consisted of 9 (3/week for 3 weeks) 45-min/session clinic-based sessions conducted by study team therapist, with concurrent caregiver training.
Phase 2 consisted of 20 (5/week for 4 weeks) 45min/session home-based sessions supervised by trained caregiver, with telemonitoring by study team therapist. Receives: Device: Jintronix Virtual Reality Telerehabilitation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl Meyer Upper Limb Motor Assessment
Measures motor impairment of upper limb recovery from a neurological insult. Range of scores from 0-66 points. Total score of 66 points with higher scores indicating better arm motor functions.
Measured: Week 0
Fugl Meyer Upper Limb Motor Assessment
Measures motor impairment of upper limb recovery from a neurological insult. Range of scores from 0-66 points. Total score of 66 points with higher scores indicating better arm motor functions.
Measured: Week 3
Fugl Meyer Upper Limb Motor Assessment
Measures motor impairment of upper limb recovery from a neurological insult. Range of scores from 0-66 points. Total score of 66 points with higher scores indicating better arm motor functions.
Measured: Week 7
Fugl Meyer Upper Limb Motor Assessment
Measures motor impairment of upper limb recovery from a neurological insult. Range of scores from 0-66 points. Total score of 66 points with higher scores indicating better arm motor functions.
Measured: Week 11
Berg Balance Scale
Measures static and dynamic balance abilities. Range of scores from 0-56 points. Total score of 56 points with higher scores indicating better balance functions.
Measured: Week 0
Berg Balance Scale
Measures static and dynamic balance abilities. Range of scores from 0-56 points. Total score of 56 points with higher scores indicating better balance functions.
Measured: Week 3
Berg Balance Scale Score
Measures static and dynamic balance abilities. Range of scores from 0-56 points. Total score of 56 points with higher scores indicating better balance functions.
Measured: Week 7
Berg Balance Scale
Measures static and dynamic balance abilities. Range of scores from 0-56 points. Total score of 56 points with higher scores indicating better balance functions.
Measured: Week 11
6 Minute Walk Test
Measures endurance inferred from distance measured directly via distance markers placed on ground, as the participant walked up and down repeatedly on a flat ground walking track for a duration of 6 minutes.
Higher distance covered by participant in this 6 minutes indicates a better outcome of higher endurance. There is no lower and upper distance limits set for this measure.
Measured: Week 0
6 Minute Walk Test
Measures endurance inferred from distance measured directly via distance markers placed on ground, as the participant walked up and down repeatedly on a flat ground walking track for a duration of 6 minutes.
Higher distance covered by participant in this 6 minutes indicates a better outcome of higher endurance. There is no lower and upper distance limits set for this measure.
Measured: Week 3
6 Minute Walk Test
Measures endurance inferred from distance measured directly via distance markers placed on ground, as the participant walked up and down repeatedly on a flat ground walking track for a duration of 6 minutes.
Higher distance covered by participant in this 6 minutes indicates a better outcome of higher endurance. There is no lower and upper distance limits set for this measure.
Measured: Week 7
6 Minute Walk Test
Measures endurance inferred from distance measured directly via distance markers placed on ground, as the participant walked up and down repeatedly on a flat ground walking track for a duration of 6 minutes.
Higher distance covered by participant in this 6 minutes indicates a better outcome of higher endurance. There is no lower and upper distance limits set for this measure.
Measured: Week 11
10 Meter Walk Test
Measures walking speed as participant walked on a flat ground walking track of 10 metres. Walking speed is calcuated by dividing 10 metres over time taken by a stopwatch.
Faster walking speed indicates a better outcome. There is no lower and upper walking speed limits set for this measure.
Measured: Week 0
10 Meter Walk Test
Measures walking speed as participant walked on a flat ground walking track of 10 metres. Walking speed is calcuated by dividing 10 metres over time taken by a stopwatch.
Faster walking speed indicates a better outcome. There is no lower and upper walking speed limits set for this measure.
Measured: Week 3
10 Meter Walk Test
Measures walking speed as participant walked on a flat ground walking track of 10 metres. Walking speed is calcuated by dividing 10 metres over time taken by a stopwatch.
Faster walking speed indicates a better outcome. There is no lower and upper walking speed limits set for this measure.
Measured: Week 7
10 Meter Walk Test
Measures walking speed as participant walked on a flat ground walking track of 10 metres. Walking speed is calcuated by dividing 10 metres over time taken by a stopwatch.
Faster walking speed indicates a better outcome. There is no lower and upper walking speed limits set for this measure.
Measured: Week 11
Numerical Pain Score
Measures pain subjectively from participant's rating. Scale is from 0 (indicating no pain experienced) to 10 (indicating worst pain experienced).
Measured: Week 0
Numerical Pain Score
Measures pain subjectively from participant's rating. Scale is from 0 (indicating no pain experienced) to 10 (indicating worst pain experienced).
Measured: Week 3
Numerical Pain Score
Measures pain subjectively from participant's rating. Scale is from 0 (indicating no pain experienced) to 10 (indicating worst pain experienced).
Measured: Week 7
Numerical Pain Score
Measures pain subjectively from participant's rating. Scale is from 0 (indicating no pain experienced) to 10 (indicating worst pain experienced).
Measured: Week 11
Stroke Self-Efficacy Questionnaire
Measures a stroke survivor's perceived level of confidence in functional performance.
Each of the 13 questions is scored on a 10-point scale (i.e. 0-10) with 0 indicating "Not At All Confident" and 10 indicating "Very Confident".
The points from the 13 questions are then added to get a total score, with a minimum score of 0 and a maximum score of 130. Higher score reflects a better outcome.
Measured: Week 0
Stroke Self-Efficacy Questionnaire
Measures a stroke survivor's perceived level of confidence in functional performance.
Each of the 13 questions is scored on a 10-point scale (i.e. 0-10) with 0 indicating "Not At All Confident" and 10 indicating "Very Confident".
The points from the 13 questions are then added to get a total score, with a minimum score of 0 and a maximum score of 130. Higher score reflects a better outcome.
Measured: Week 7
Stroke Self-Efficacy Questionnaire
Measures a stroke survivor's perceived level of confidence in functional performance.
Each of the 13 questions is scored on a 10-point scale (i.e. 0-10) with 0 indicating "Not At All Confident" and 10 indicating "Very Confident".
The points from the 13 questions are then added to get a total score, with a minimum score of 0 and a maximum score of 130. Higher score reflects a better outcome..
Measured: Week 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start5 Jan 2017
- Primary completion14 Nov 2018
- Study completion14 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective open label study.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kuah Wee Keong Christopher, Tan Tock Seng Hospital
- Investigators
- Wee Keong Christopher Kuah, MSc, Principal investigator, Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04333758
- Sponsor's protocol ID
- NHG DSRB 2016/00442
- Status last verified
- May 2024
- First submitted
- 17 Mar 2020
- Last updated
- 18 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient and Home Advanced Rehabilitation Therapeutics Using Jintronix Virtual Reality Telerehabilitation System
- ClinicalTrials.gov ID
- NCT04333758
- Acronym / sponsor ID
- NHG DSRB 2016/00442
- Conditions
- Stroke
- Keywords
- Rehabilitation, Telerehabilitation, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Study start
- 5 Jan 2017 (actual)
- Primary completion
- 14 Nov 2018 (actual)
- Study completion
- 14 Nov 2018 (actual)
- First posted
- 3 Apr 2020 (actual)
- Results
- Posted 18 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The use of virtual reality technology in a telerehabilitation service is not well established in Singapore. This feasibility trial aims to evaluate the benefits of using Jintronix to deliver a clinic-to-home, caregiver-supervised and individualised exercise telerehabilitation program to complement outpatient services and improve clinical outcomes for post-stroke users.
Detailed description
With the emphasis on improving population health, reducing the need for hospital care, and promoting self-management, it will be beneficial to make good use of current available technologies to complement centre-based therapy with cost effectiveness and efficiency.
One mode of such care delivery to a patient's home is through a telerehabilitation system that enables remote monitoring of patients' participation and performance in individualised home exercises. In addition, timely review and adjustments in the home programs to cater to progress or changes in patients' performance can be carried out by therapists remotely.
In the recent years, there has been an increased utilisation of virtual reality applications in physical rehabilitation for specific training objectives, such as, movement retraining, balance control and strength training. Virtual reality exercises when prescribed with defined training objectives and duration can potentially be valuable to increase patients' training intensity in the comfort of their own homes.
The majority of patients receiving outpatient and home based rehabilitation at Tan Tock Seng Hospital (TTSH) Rehabilitation Centre (RC) and Centre for Advanced Rehabilitation Therapeutics (CART) are patients who have had a stroke. Hence this group of outpatients that are at least 3 months post-stroke will be recruited for this trial. It is hypothesized that they will benefit from increased intensity of upper limb, balance and/or gait rehabilitation with Jintronix telerehabilitation system that facilitates them to further exercise at home and not just at the clinic.
The study is thus designed to evaluate the feasibility of a novel telerehabilitation service based on the Jintronix Virtual Reality Platform to complement existing outpatient therapy services of TTSH RC (including its outpatient service arm at CART).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective open label study.
| Arm | Type | Receives |
|---|---|---|
| Jintronix Intervention | Experimental | Device: Jintronix Virtual Reality Telerehabilitation System2 consecutive phases of intervention for all participants using Jintronix virtual reality telerehabilitation software. Phase 1 consisted of 9 (3/week for 3 weeks) 45-min/session clinic-based sessions conducted by study team therapist, with concurrent caregiver training. Phase 2 consisted of 20 (5/week for 4 weeks) 45min/session home-based sessions supervised by trained caregiver, with telemonitoring by study team therapist. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients with motor deficits due to stroke as diagnosed by CT or MRI, who are attending outpatient rehabilitation services at Tan Tock Seng Hospital Rehabilitation Centre and Centre for Advanced Rehabilitation Therapeutics
- post stroke of at least 3 months with stable neurological status
- 21-75 years old
- able to perform at minimal level of assistance (i.e. carer provides only up to 25% of physical support) for sitting, standing and/or walking tasks
- has a primary caregiver that must be present in all trial sessions
Key exclusion criteria (8 listed)
- has seizure history
- has severe cognitive deficits, perceptual deficits, and/or emotional-behavioural issues
- has unstable medical conditions which may affect participation (e.g unresolved sepsis, postural hypotension, end stage renal failure) or anticipated life expectancy of <1 year due to malignancy or neurodegenerative disorder
- has pain score of >5
- is pregnant or breastfeeding
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 |
|---|---|---|
| Jintronix Virtual Reality Telerehabilitation SystemAlso: JintronixSystem consists of an internet-based rehabilitation software linked to a Microsoft Kinect camera for motion detection. Study team therapist prescribed a list of guided exercises and therapeutic activities (games) for training of whole body, lower and upper extremities. These can be done in sitting or standing, depending on individual participant's capacity. Telemonitoring is done by study team therapist during each of the training day (Mondays-Fridays) of the home-based training phase. Training performance results are reviewed and training games are adjusted or changed to optimise home training. | Device | Jintronix Intervention |
Primary outcome
Fugl Meyer Upper Limb Motor Assessment
Time frame: Week 0
Measures motor impairment of upper limb recovery from a neurological insult. Range of scores from 0-66 points. Total score of 66 points with higher scores indicating better arm motor functions.
Fugl Meyer Upper Limb Motor Assessment
Time frame: Week 3
Measures motor impairment of upper limb recovery from a neurological insult. Range of scores from 0-66 points. Total score of 66 points with higher scores indicating better arm motor functions.
Fugl Meyer Upper Limb Motor Assessment
Time frame: Week 7
Measures motor impairment of upper limb recovery from a neurological insult. Range of scores from 0-66 points. Total score of 66 points with higher scores indicating better arm motor functions.
Fugl Meyer Upper Limb Motor Assessment
Time frame: Week 11
Measures motor impairment of upper limb recovery from a neurological insult. Range of scores from 0-66 points. Total score of 66 points with higher scores indicating better arm motor functions.
Berg Balance Scale
Time frame: Week 0
Measures static and dynamic balance abilities. Range of scores from 0-56 points. Total score of 56 points with higher scores indicating better balance functions.
Berg Balance Scale
Time frame: Week 3
Measures static and dynamic balance abilities. Range of scores from 0-56 points. Total score of 56 points with higher scores indicating better balance functions.
Berg Balance Scale Score
Time frame: Week 7
Measures static and dynamic balance abilities. Range of scores from 0-56 points. Total score of 56 points with higher scores indicating better balance functions.
Berg Balance Scale
Time frame: Week 11
Measures static and dynamic balance abilities. Range of scores from 0-56 points. Total score of 56 points with higher scores indicating better balance functions.
6 Minute Walk Test
Time frame: Week 0
Measures endurance inferred from distance measured directly via distance markers placed on ground, as the participant walked up and down repeatedly on a flat ground walking track for a duration of 6 minutes. Higher distance covered by participant in this 6 minutes indicates a better outcome of higher endurance. There is no lower and upper distance limits set for this measure.
6 Minute Walk Test
Time frame: Week 3
Measures endurance inferred from distance measured directly via distance markers placed on ground, as the participant walked up and down repeatedly on a flat ground walking track for a duration of 6 minutes. Higher distance covered by participant in this 6 minutes indicates a better outcome of higher endurance. There is no lower and upper distance limits set for this measure.
6 Minute Walk Test
Time frame: Week 7
Measures endurance inferred from distance measured directly via distance markers placed on ground, as the participant walked up and down repeatedly on a flat ground walking track for a duration of 6 minutes. Higher distance covered by participant in this 6 minutes indicates a better outcome of higher endurance. There is no lower and upper distance limits set for this measure.
6 Minute Walk Test
Time frame: Week 11
Measures endurance inferred from distance measured directly via distance markers placed on ground, as the participant walked up and down repeatedly on a flat ground walking track for a duration of 6 minutes. Higher distance covered by participant in this 6 minutes indicates a better outcome of higher endurance. There is no lower and upper distance limits set for this measure.
10 Meter Walk Test
Time frame: Week 0
Measures walking speed as participant walked on a flat ground walking track of 10 metres. Walking speed is calcuated by dividing 10 metres over time taken by a stopwatch. Faster walking speed indicates a better outcome. There is no lower and upper walking speed limits set for this measure.
10 Meter Walk Test
Time frame: Week 3
Measures walking speed as participant walked on a flat ground walking track of 10 metres. Walking speed is calcuated by dividing 10 metres over time taken by a stopwatch. Faster walking speed indicates a better outcome. There is no lower and upper walking speed limits set for this measure.
10 Meter Walk Test
Time frame: Week 7
Measures walking speed as participant walked on a flat ground walking track of 10 metres. Walking speed is calcuated by dividing 10 metres over time taken by a stopwatch. Faster walking speed indicates a better outcome. There is no lower and upper walking speed limits set for this measure.
10 Meter Walk Test
Time frame: Week 11
Measures walking speed as participant walked on a flat ground walking track of 10 metres. Walking speed is calcuated by dividing 10 metres over time taken by a stopwatch. Faster walking speed indicates a better outcome. There is no lower and upper walking speed limits set for this measure.
Numerical Pain Score
Time frame: Week 0
Measures pain subjectively from participant's rating. Scale is from 0 (indicating no pain experienced) to 10 (indicating worst pain experienced).
Numerical Pain Score
Time frame: Week 3
Measures pain subjectively from participant's rating. Scale is from 0 (indicating no pain experienced) to 10 (indicating worst pain experienced).
Numerical Pain Score
Time frame: Week 7
Measures pain subjectively from participant's rating. Scale is from 0 (indicating no pain experienced) to 10 (indicating worst pain experienced).
Numerical Pain Score
Time frame: Week 11
Measures pain subjectively from participant's rating. Scale is from 0 (indicating no pain experienced) to 10 (indicating worst pain experienced).
Stroke Self-Efficacy Questionnaire
Time frame: Week 0
Measures a stroke survivor's perceived level of confidence in functional performance. Each of the 13 questions is scored on a 10-point scale (i.e. 0-10) with 0 indicating "Not At All Confident" and 10 indicating "Very Confident". The points from the 13 questions are then added to get a total score, with a minimum score of 0 and a maximum score of 130. Higher score reflects a better outcome.
Stroke Self-Efficacy Questionnaire
Time frame: Week 7
Measures a stroke survivor's perceived level of confidence in functional performance. Each of the 13 questions is scored on a 10-point scale (i.e. 0-10) with 0 indicating "Not At All Confident" and 10 indicating "Very Confident". The points from the 13 questions are then added to get a total score, with a minimum score of 0 and a maximum score of 130. Higher score reflects a better outcome.
Stroke Self-Efficacy Questionnaire
Time frame: Week 11
Measures a stroke survivor's perceived level of confidence in functional performance. Each of the 13 questions is scored on a 10-point scale (i.e. 0-10) with 0 indicating "Not At All Confident" and 10 indicating "Very Confident". The points from the 13 questions are then added to get a total score, with a minimum score of 0 and a maximum score of 130. Higher score reflects a better outcome..
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Wee Keong Christopher Kuah, MSc principal investigator
Tan Tock Seng 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 Jintronix Virtual Reality Telerehabilitation System in people with Stroke, run by Tan Tock Seng Hospital at 1 site in Singapore.
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 6 inclusion and 8 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 18 Jun 2024. 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 Singapore. 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?
Yes. Results are posted in the registry (first posted 18 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Limb Motor Assessment (time frame: Week 0). The study lists 23 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 18 Jun 2024.