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

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

Study Overview

• Status: Completed
• Conditions: Stroke, Acute
• Intervention / Treatment: Device: Silverfit 3D

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 308433
    • Tan Tock Seng Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
reduce length of stay in ICU	Reduce length of stay in ICU	3 months

Collaborators and Investigators

• Sponsor: Tan Tock Seng Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2020
• Primary Completion (Actual): March 2, 2021
• Study Completion (Actual): April 13, 2021

Study Registration Dates

• First Submitted: July 5, 2020
• First Submitted That Met QC Criteria: May 3, 2021
• First Posted (Actual): May 5, 2021

Study Record Updates

• Last Update Posted (Actual): May 5, 2021
• Last Update Submitted That Met QC Criteria: May 3, 2021
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: rehabilitation; virtual reality; Silverfit 3D
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2020/00143

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No