Stroke, AcuteNCT04874181
Use of Virtual Reality Game in Rehabilitation of Stroke Patients in Tan Tock Seng Hospital
A study testing Silverfit 3D in people with Stroke, Acute, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial summary
Use of SIlverfit 3d to aid in rehab of stroke patients focusing on their shoulder and knee strength Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- Silverfit 3D
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSingapore
- Study dates
- 27 Jul 2020to 13 Apr 2021
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 21 - 90 years old
- Diagnosis of stroke of pure motor/sensory type affecting the limbs, all levels of severity and at all stages post stroke, defined by the WHO as "a syndrome of rapidly developing symptoms and signs of focal, and at times global, loss of cerebral function lasting more than 24 hours or leading to death with no apparent cause other than that of vascular origin" (WHO 1989), diagnosed by imaging or neurological examination
- GCS 14 - 15
- RASS -1 to +1
- Blood pressure within 20% of patient's baseline
- Muscle power at least 2 out of 5 on the affected side, as assessed by the physiotherapist or clinician
Who cannot join
- Age less than 21 or more than 90 years old
- Neurological instability
- Poor prognosis/expected withdrawal of treatment/palliative care patient
- Visual loss/hearing loss
- Active delirium with inability to cooperate as determined by CAM-ICU positivity
- Severe cognitive impairment/dementia
- Haemodynamic instability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Proof Of Concept Single Arm Study To Use Virtual Reality in Rehabilitation of Stroke Patients in Neuro Intensive Care Unit in Tan Tock Seng Hospital
Use of SIlverfit 3d to aid in rehab of stroke patients focusing on their shoulder and knee strength
Read the detailed description
Either 1 of 3 physiotherapists will recruit the patient from NICU if the GCS is 14 - 15. Silverfit 3D will then be used for 20 minutes each day to train the knee and arm strength until the patient's discharge from ICU. Baseline muscle strength will be measured and graded by the physiotherapist using Medical Research Council grading then followed up by the same physiotherapist on discharge from ICU and on discharge from hospital.
- Conditions
- Stroke, Acute
- Being tested
- Silverfit 3D
- Keywords
- virtual reality, Silverfit 3D, rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silverfit 3DDevice
Virtual reality game used for rehabilitation of stroke patients
| Study group | Role | What they receive |
|---|---|---|
| Silverfit 3D | Experimental | The subject will use SIlverfit 3D for rehabilitation of his/her shoulder/knee strength post stroke. Receives: Device: Silverfit 3D |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate an improvement in muscle strength using the Medical Research Council (MRC) grading following the intervention.
Use of MRC grade to estimate improvement in muscle strength by a group of trained physiotherapists before, during and after the use of virtual reality equipment.
Measured: 3 months
estimate how much a patient can do compared to his/her baseline in terms of ability to stand/ambulation/reaching out for objects based on the physiotherapist who first saw the patient.
Patients will be interviewed on admission by the physiotherapist to find out his/her baseline activities of daily living/strength and limb power. Physiotherapists will assess the patient again on day of discharge to find out how much the patient is able to return to his/her baseline post stroke. This is a descriptive outcome measure as it is only measured by 1 physiotherapist who has seen the patient on admission and then on discharge from hospital.
Measured: 3 months
increase frequency and intensity of rehab activities in stroke patients
To increase frequency of rehab activities in patients in terms of percentage of patients who can do, time of each exercise
Measured: 6 months
Secondary outcomes (1)
reduce length of stay in ICU
Reduce length of stay in ICU
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start27 Jul 2020
- Primary completion2 Mar 2021
- Study completion13 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Arm study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874181
- Sponsor's protocol ID
- 2020/00143
- Status last verified
- Jul 2020
- First submitted
- 5 Jul 2020
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof Of Concept Single Arm Study To Use Virtual Reality in Rehabilitation of Stroke Patients in Neuro Intensive Care Unit in Tan Tock Seng Hospital
- ClinicalTrials.gov ID
- NCT04874181
- Acronym / sponsor ID
- 2020/00143
- Conditions
- Stroke, Acute
- Keywords
- virtual reality, Silverfit 3D, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 2 Mar 2021 (actual)
- Study completion
- 13 Apr 2021 (actual)
- First posted
- 5 May 2021 (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.
Use of SIlverfit 3d to aid in rehab of stroke patients focusing on their shoulder and knee strength
Detailed description
Either 1 of 3 physiotherapists will recruit the patient from NICU if the GCS is 14 - 15. Silverfit 3D will then be used for 20 minutes each day to train the knee and arm strength until the patient's discharge from ICU. Baseline muscle strength will be measured and graded by the physiotherapist using Medical Research Council grading then followed up by the same physiotherapist on discharge from ICU and on discharge from hospital.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Arm study
| Arm | Type | Receives |
|---|---|---|
| Silverfit 3D | Experimental | Device: Silverfit 3DThe subject will use SIlverfit 3D for rehabilitation of his/her shoulder/knee strength post stroke. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients 21 - 90 years old
- Diagnosis of stroke of pure motor/sensory type affecting the limbs, all levels of severity and at all stages post stroke, defined by the WHO as "a syndrome of rapidly developing symptoms and signs of focal, and at times global, loss of cerebral function lasting more than 24 hours or leading to death with no apparent cause other than that of vascular origin" (WHO 1989), diagnosed by imaging or neurological examination
- GCS 14 - 15
- RASS -1 to +1
- Blood pressure within 20% of patient's baseline
Key exclusion criteria (7 listed)
- Age less than 21 or more than 90 years old
- Neurological instability
- Poor prognosis/expected withdrawal of treatment/palliative care patient
- Visual loss/hearing loss
- Active delirium with inability to cooperate as determined by CAM-ICU positivity
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 |
|---|---|---|
| Silverfit 3DVirtual reality game used for rehabilitation of stroke patients | Device | Silverfit 3D |
Primary outcome
To estimate an improvement in muscle strength using the Medical Research Council (MRC) grading following the intervention.
Time frame: 3 months
Use of MRC grade to estimate improvement in muscle strength by a group of trained physiotherapists before, during and after the use of virtual reality equipment.
estimate how much a patient can do compared to his/her baseline in terms of ability to stand/ambulation/reaching out for objects based on the physiotherapist who first saw the patient.
Time frame: 3 months
Patients will be interviewed on admission by the physiotherapist to find out his/her baseline activities of daily living/strength and limb power. Physiotherapists will assess the patient again on day of discharge to find out how much the patient is able to return to his/her baseline post stroke. This is a descriptive outcome measure as it is only measured by 1 physiotherapist who has seen the patient on admission and then on discharge from hospital.
increase frequency and intensity of rehab activities in stroke patients
Time frame: 6 months
To increase frequency of rehab activities in patients in terms of percentage of patients who can do, time of each exercise
1 secondary outcome
reduce length of stay in ICU
Time frame: 3 months
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 5 May 2021.
- Individual participant dataSharing planned: No
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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 Silverfit 3D in people with Stroke, Acute, 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 7 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 5 May 2021. 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?
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?
To estimate an improvement in muscle strength using the Medical Research Council (MRC) grading following the intervention. (time frame: 3 months). 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 5 May 2021.