Outpatient and Home Advanced Rehabilitation Therapeutics Using Jintronix Virtual Reality Telerehabilitation System

Study Overview
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Brief Summary
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The use of virtual reality technology in a telerehabilitation service is not well established in Singapore. This feasibility trial aims to evaluate the benefits of using Jintronix to deliver a clinic-to-home, caregiver-supervised and individualised exercise telerehabilitation program to complement outpatient services and improve clinical outcomes for post-stroke users.

Official Title
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Outpatient and Home Advanced Rehabilitation Therapeutics Using Jintronix Virtual Reality Telerehabilitation System

Conditions
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Stroke

Intervention / Treatment
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* Device: Jintronix Virtual Reality Telerehabilitation System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with motor deficits due to stroke as diagnosed by CT or MRI, who are attending outpatient rehabilitation services at Tan Tock Seng Hospital Rehabilitation Centre and Centre for Advanced Rehabilitation Therapeutics post stroke of at least 3 months with stable neurological status 21-75 years old able to perform at minimal level of assistance (i.e. carer provides only up to 25% of physical support) for sitting, standing and/or walking tasks has a primary caregiver that must be present in all trial sessions able to understand and participate in a 15 minutes Jintronix trial during screening Exclusion Criteria: has seizure history has severe cognitive deficits, perceptual deficits, and/or emotional-behavioural issues has unstable medical conditions which may affect participation (e.g unresolved sepsis, postural hypotension, end stage renal failure) or anticipated life expectancy of <1 year due to malignancy or neurodegenerative disorder has pain score of >5 is pregnant or breastfeeding has known poor cardiac ejection fraction (<30%) or lung function (FEV1<30%) has non-weight bearing status in either lower extremities has caregiver who is unable to meet competency requirements as assessed by study team

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective open label study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jintronix Intervention<br>2 consecutive phases of intervention for all participants using Jintronix virtual reality telerehabilitation software. Phase 1 consisted of 9 (3/week for 3 weeks) 45-min/session clinic-based sessions conducted by study team therapist, with concurrent caregiver training. Phase 2 consisted of 20 (5/week for 4 weeks) 45min/session home-based sessions supervised by trained caregiver, with telemonitoring by study team therapist. | Device: Jintronix Virtual Reality Telerehabilitation System<br>* System consists of an internet-based rehabilitation software linked to a Microsoft Kinect camera for motion detection. Study team therapist prescribed a list of guided exercises and therapeutic activities (games) for training of whole body, lower and upper extremities. These can be done in sitting or standing, depending on individual participant's capacity. Telemonitoring is done by study team therapist during each of the training day (Mondays-Fridays) of the home-based training phase. Training performance results are reviewed and training games are adjusted or changed to optimise home training.<br>* Other names: Jintronix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl Meyer Upper Limb Motor Assessment | Measures motor impairment of upper limb recovery from a neurological insult. | Week 0 | 
| Change of Fugl Meyer Upper Limb Motor Assessment Score from Week 0 | Measures change of motor impairment of upper limb recovery from a neurological insult. | Week 3 | 
| Change of Fugl Meyer Upper Limb Motor Assessment Score from Week 3 | Measures change of motor impairment of upper limb recovery from a neurological insult. | Week 7 | 
| Change of Fugl Meyer Upper Limb Motor Assessment Score from Week 7 | Measures change of motor impairment of upper limb recovery from a neurological insult. | Week 11 | 
| Berg Balance Scale | Measures static and dynamic balance abilities. | Week 0 | 
| Change of Berg Balance Scale Score from Week 0 | Measures change of static and dynamic balance abilities. | Week 3 | 
| Change of Berg Balance Scale Score from Week 3 | Measures change of static and dynamic balance abilities. | Week 7 | 
| Change of Berg Balance Scale Score from Week 7 | Measures change of static and dynamic balance abilities. | Week 11 | 
| 6 Minute Walk Test | Measures endurance inferred from distance walked over 6 minutes. | Week 0 | 
| Change of 6 Minute Walk Test Score from Week 0 | Measures change of endurance inferred from distance walked over 6 minutes. | Week 3 | 
| Change of 6 Minute Walk Test Score from Week 3 | Measures change of endurance inferred from distance walked over 6 minutes. | Week 7 | 
| Change of 6 Minute Walk Test Score from Week 7 | Measures change of endurance inferred from distance walked over 6 minutes. | Week 11 | 
| 10 Meter Walk Test | Measures walking speed over 10 meters. | Week 0 | 
| Change of 10 Meter Walk Test Score from Week 0 | Measures change of walking speed over 10 meters. | Week 3 | 
| Change of 10 Meter Walk Test Score from Week 3 | Measures change of walking speed over 10 meters. | Week 7 | 
| Change of 10 Meter Walk Test Score from Week 7 | Measures change of walking speed over 10 meters. | Week 11 | 
| Pain Score | Measures pain subjectively from participant's rating of 0 (no pain) to 10 (worst pain). | Week 0 | 
| Change of Pain Score from Week 0 | Measures change of pain subjectively from participant's rating of 0 (no pain) to 10 (worst pain). | Week 3 | 
| Change of Pain Score from Week 3 | Measures change of pain subjectively from participant's rating of 0 (no pain) to 10 (worst pain). | Week 7 | 
| Change of Pain Score from Week 7 | Measures change of pain subjectively from participant's rating of 0 (no pain) to 10 (worst pain). | Week 11 | 
| Stroke Self-Efficacy Questionnaire | Measures a stroke survivor's perceived level of confidence in functional performance. | Week 0 | 
| Change of Stroke Self-Efficacy Questionnaire Scores from Week 0 | Measures change of a stroke survivor's perceived level of confidence in functional performance. | Week 7 | 
| Change of Stroke Self-Efficacy Questionnaire Scores from Week 7 | Measures change of a stroke survivor's perceived level of confidence in functional performance. | Week 11 | 
| Subjective Feedback Questionnaire | A. Measures a participant's level of agreement on a 5-point Likert scale with the following points: i. ease of setup; (ii) ease of following instructions of system; (iii) if training was enjoyable; (iv) if therapist was able to monitor participant's performance; (v) if exercises were prescribed at right level of challenge; (vi) if this approach motivated participant to keep up with exercises; and (vii) if such training should be recommended to others. B. Additional comments with regards to participants' experiences in the study, if any, were also collected. | Week11 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation, Telerehabilitation, Virtual Reality