N/A
N=35
Outpatient and Home Advanced Rehabilitation Therapeutics Using Jintronix Virtual Reality Telerehabilitation System
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT04333758 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Fugl Meyer Upper Limb Motor Assessment — 36.52 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Jintronix Virtual Reality Telerehabilitation System (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Tan Tock Seng Hospital
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fugl Meyer Upper Limb Motor Assessment |
40.00 | — |
| PRIMARY Fugl Meyer Upper Limb Motor Assessment |
40.00 | — |
| PRIMARY Fugl Meyer Upper Limb Motor Assessment |
40.00 | — |
| PRIMARY Fugl Meyer Upper Limb Motor Assessment |
40.00 | — |
| PRIMARY Berg Balance Scale |
48.59 | — |
| PRIMARY Berg Balance Scale |
48.59 | — |
| PRIMARY Berg Balance Scale Score |
47.59 | — |
| PRIMARY Berg Balance Scale |
48.59 | — |
| PRIMARY 6 Minute Walk Test |
250.78 | — |
| PRIMARY 6 Minute Walk Test |
250.78 | — |
| PRIMARY 6 Minute Walk Test |
250.78 | — |
| PRIMARY 6 Minute Walk Test |
250.78 | — |
| PRIMARY 10 Meter Walk Test |
0.78 | — |
| PRIMARY 10 Meter Walk Test |
0.78 | — |
| PRIMARY 10 Meter Walk Test |
0.78 | — |
| PRIMARY 10 Meter Walk Test |
0.78 | — |
| PRIMARY Numerical Pain Score |
-0.103 | — |
| PRIMARY Numerical Pain Score |
-0.103 | — |
| PRIMARY Numerical Pain Score |
-0.103 | — |
| PRIMARY Numerical Pain Score |
-0.103 | — |
| PRIMARY Stroke Self-Efficacy Questionnaire |
93.59 | — |
| PRIMARY Stroke Self-Efficacy Questionnaire |
93.59 | — |
| PRIMARY Stroke Self-Efficacy Questionnaire |
93.59 | — |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT04333758). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.