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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date July 2020
Source Tan Tock Seng Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Use of SIlverfit 3d to aid in rehab of stroke patients focusing on their shoulder and knee strength


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Silverfit 3D
Virtual reality game used for rehabilitation of stroke patients

Locations

Country Name City State
Singapore Tan Tock Seng Hospital Singapore

Sponsors (1)

Lead Sponsor Collaborator
Tan Tock Seng Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

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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