Clinical trial NCT04333758: Outpatient and Home Advanced Rehabilitation Therapeutics Using Jintronix Virtual Reality Telerehabilitation System
Official title: Outpatient and Home Advanced Rehabilitation Therapeutics Using Jintronix Virtual Reality Telerehabilitation System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Rehabilitation, Telerehabilitation, Virtual Reality
Lead sponsor: Tan Tock Seng Hospital
Sponsor class: OTHER
First posted: 2020-04-03
Enrollment: 35
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective open label study.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: With the emphasis on improving population health, reducing the need for hospital care, and promoting self-management, it will be beneficial to make good use of current available technologies to complement centre-based therapy with cost effectiveness and efficiency.

One mode of such care delivery to a patient's home is through a telerehabilitation system that enables remote monitoring of patients' participation and performance in individualised home exercises. In addition, timely review and adjustments in the home programs to cater to progress or changes in patients' performance can be carried out by therapists remotely.

In the recent years, there has been an increased utilisation of virtual reality applications in physical rehabilitation for specific training objectives, such as, movement retraining, balance control and strength training. Virtual reality exercises when prescribed with defined training objectives and duration can potentially be valuable to increase patients' training intensity in the comfort of their own homes.

The majority of patients receiving outpatient and home based rehabilitation at Tan Tock Seng Hospital (TTSH) Rehabilitation Centre (RC) and Centre for Advanced Rehabilitation Therapeutics (CART) are patients who have had a stroke. Hence this group of outpatients that are at least 3 months post-stroke will be recruited for this trial. It is hypothesized that they will benefit from increased intensity of upper limb, balance and/or gait rehabilitation with Jintronix telerehabilitation system that facilitates them to further exercise at home and not just at the clinic.

The study is thus designed to evaluate the feasibility of a novel telerehabilitation service based on the Jintronix Virtual Reality Platform to complement existing outpatient therapy services of TTSH RC (including its outpatient service arm at CART).

Eligibility criteria: 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

Primary outcomes:
measure: Fugl Meyer Upper Limb Motor Assessment
timeFrame: Week 0
measure: Fugl Meyer Upper Limb Motor Assessment
timeFrame: Week 3
measure: Fugl Meyer Upper Limb Motor Assessment
timeFrame: Week 7
measure: Fugl Meyer Upper Limb Motor Assessment
timeFrame: Week 11
measure: Berg Balance Scale
timeFrame: Week 0
measure: Berg Balance Scale
timeFrame: Week 3
measure: Berg Balance Scale Score
timeFrame: Week 7
measure: Berg Balance Scale
timeFrame: Week 11
measure: 6 Minute Walk Test
timeFrame: Week 0
measure: 6 Minute Walk Test
timeFrame: Week 3
measure: 6 Minute Walk Test
timeFrame: Week 7
measure: 6 Minute Walk Test
timeFrame: Week 11
measure: 10 Meter Walk Test
timeFrame: Week 0
measure: 10 Meter Walk Test
timeFrame: Week 3
measure: 10 Meter Walk Test
timeFrame: Week 7
measure: 10 Meter Walk Test
timeFrame: Week 11
measure: Numerical Pain Score
timeFrame: Week 0
measure: Numerical Pain Score
timeFrame: Week 3
measure: Numerical Pain Score
timeFrame: Week 7
measure: Numerical Pain Score
timeFrame: Week 11
measure: Stroke Self-Efficacy Questionnaire
timeFrame: Week 0
measure: Stroke Self-Efficacy Questionnaire
timeFrame: Week 7
measure: Stroke Self-Efficacy Questionnaire
timeFrame: Week 11
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Centre for Advanced Rehabilitation Therapeutics, Tan Tock Seng Hospital
Study officials:
affiliation: Tan Tock Seng Hospital
name: Wee Keong Christopher Kuah, MSc
role: PRINCIPAL_INVESTIGATOR
References: