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

Primary Purpose

Stroke, Acute

Status

Completed

Phase

Not Applicable

Locations

Singapore

Study Type

Interventional

Intervention

Silverfit 3D

About this trial

This is an interventional supportive care trial for Stroke, Acute focused on measuring virtual reality, Silverfit 3D, rehabilitation

Eligibility Criteria

21 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Tan Tock Seng Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Silverfit 3D

Arm Description

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

Outcomes

Primary Outcome Measures

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.

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.

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

Secondary Outcome Measures

reduce length of stay in ICU

Reduce length of stay in ICU

Full Information

NCT ID

NCT04874181

First Posted

July 5, 2020

Last Updated

May 3, 2021

Sponsor

Tan Tock Seng Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04874181

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

July 27, 2020 (Actual)

Primary Completion Date

March 2, 2021 (Actual)

Study Completion Date

April 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tan Tock Seng Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Acute

Keywords

virtual reality, Silverfit 3D, rehabilitation

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Single Arm study

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Silverfit 3D

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Silverfit 3D

Intervention Description

Virtual reality game used for rehabilitation of stroke patients

Primary Outcome Measure Information:

Title

To estimate an improvement in muscle strength using the Medical Research Council (MRC) grading following the intervention.

Description

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.

Time Frame

3 months

Title

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.

Description

Time Frame

3 months

Title

increase frequency and intensity of rehab activities in stroke patients

Description

To increase frequency of rehab activities in patients in terms of percentage of patients who can do, time of each exercise

Time Frame

6 months

Secondary Outcome Measure Information:

Title

reduce length of stay in ICU

Description

Reduce length of stay in ICU

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Tan Tock Seng Hospital

City

Singapore

ZIP/Postal Code

308433

Country

Singapore

12. IPD Sharing Statement

Plan to Share IPD

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

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