Stroke, Acute Clinical Trial
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
NCT number | NCT04874181 |
Other study ID # | 2020/00143 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 27, 2020 |
Est. completion date | April 13, 2021 |
Verified date | July 2020 |
Source | Tan Tock Seng Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Use of SIlverfit 3d to aid in rehab of stroke patients focusing on their shoulder and knee strength
Status | Completed |
Enrollment | 20 |
Est. completion date | April 13, 2021 |
Est. primary completion date | March 2, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 90 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Singapore | Tan Tock Seng Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
Tan Tock Seng Hospital |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 3 months | |
Primary | 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. | 3 months | |
Primary | 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 | 6 months | |
Secondary | reduce length of stay in ICU | Reduce length of stay in ICU | 3 months |
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