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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Jintronix Virtual Reality Telerehabilitation System

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• 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: Jintronix Intervention; 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; 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.; Other Names: Jintronix

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tan Tock Seng Hospital
• Investigators: Principal Investigator: Wee Keong Christopher Kuah, MSc, Tan Tock Seng Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2017
• Primary Completion (Actual): November 14, 2018
• Study Completion (Actual): November 14, 2018

Study Registration Dates

• First Submitted: March 17, 2020
• First Submitted That Met QC Criteria: April 1, 2020
• First Posted (Actual): April 3, 2020

Study Record Updates

• Last Update Posted (Actual): April 3, 2020
• Last Update Submitted That Met QC Criteria: April 1, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Rehabilitation, Telerehabilitation, Virtual Reality
• Other Study ID Numbers: NHG DSRB 2016/00442

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes