Use of Virtual Reality Game in Rehabilitation of Stroke Patients in Tan Tock Seng Hospital

Sponsor

Tan Tock Seng Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04874181

Collaborator

(none)

Enrollment

Location

Arm

8.5

Actual Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Stroke, Acute	Device: Silverfit 3D	N/A

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

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Single Arm studySingle Arm study

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Jul 27, 2020

Actual Primary Completion Date :

Mar 2, 2021

Actual Study Completion Date :

Apr 13, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Silverfit 3D The subject will use SIlverfit 3D for rehabilitation of his/her shoulder/knee strength post stroke.	Device: Silverfit 3D Virtual reality game used for rehabilitation of stroke patients

Arm

Intervention/Treatment

Experimental: Silverfit 3D

The subject will use SIlverfit 3D for rehabilitation of his/her shoulder/knee strength post stroke.

Device: Silverfit 3D

Virtual reality game used for rehabilitation of stroke patients

Outcome Measures

Primary Outcome Measures

To estimate an improvement in muscle strength using the Medical Research Council (MRC) grading following the intervention. [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. [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 [6 months]
To increase frequency of rehab activities in patients in terms of percentage of patients who can do, time of each exercise

Secondary Outcome Measures

reduce length of stay in ICU [3 months]
Reduce length of stay in ICU

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tan Tock Seng Hospital	Singapore		Singapore	308433

Sponsors and Collaborators

Tan Tock Seng Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tan Tock Seng Hospital

ClinicalTrials.gov Identifier:

NCT04874181

Other Study ID Numbers:

2020/00143

First Posted:

May 5, 2021

Last Update Posted:

May 5, 2021

Last Verified:

Jul 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Tan Tock Seng Hospital

virtual reality

Silverfit 3D

rehabilitation

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of May 5, 2021