Stroke
Conditions
Keywords
Rehabilitation, Telerehabilitation, Virtual Reality
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).
Interventions
DEVICEJintronix 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.
Sponsors
Tan Tock Seng Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective open label study.
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl Meyer Upper Limb Motor Assessment | Week 0 | Measures motor impairment of upper limb recovery from a neurological insult. Range of scores from 0-66 points. Total score of 66 points with higher scores indicating better arm motor functions. |
| Berg Balance Scale | Week 0 | Measures static and dynamic balance abilities. Range of scores from 0-56 points. Total score of 56 points with higher scores indicating better balance functions. |
| Berg Balance Scale Score | Week 7 | Measures static and dynamic balance abilities. Range of scores from 0-56 points. Total score of 56 points with higher scores indicating better balance functions. |
| 6 Minute Walk Test | Week 0 | Measures endurance inferred from distance measured directly via distance markers placed on ground, as the participant walked up and down repeatedly on a flat ground walking track for a duration of 6 minutes. Higher distance covered by participant in this 6 minutes indicates a better outcome of higher endurance. There is no lower and upper distance limits set for this measure. |
| 10 Meter Walk Test | Week 0 | Measures walking speed as participant walked on a flat ground walking track of 10 metres. Walking speed is calcuated by dividing 10 metres over time taken by a stopwatch. Faster walking speed indicates a better outcome. There is no lower and upper walking speed limits set for this measure. |
| Numerical Pain Score | Week 0 | Measures pain subjectively from participant's rating. Scale is from 0 (indicating no pain experienced) to 10 (indicating worst pain experienced). |
| Stroke Self-Efficacy Questionnaire | Week 0 | Measures a stroke survivor's perceived level of confidence in functional performance. Each of the 13 questions is scored on a 10-point scale (i.e. 0-10) with 0 indicating Not At All Confident and 10 indicating Very Confident. The points from the 13 questions are then added to get a total score, with a minimum score of 0 and a maximum score of 130. Higher score reflects a better outcome. |
Countries
Singapore
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 32 |
| Total | 32 |
Baseline characteristics
| Characteristic | Jintronix Intervention |
|---|---|
| Age, Continuous | 55.03 years STANDARD_DEVIATION 11.39 |
| Education, Customized Institute of Technical Education | 3 Participants |
| Education, Customized Polytechnic Education | 5 Participants |
| Education, Customized Primary School | 5 Participants |
| Education, Customized Secondary School | 2 Participants |
| Education, Customized Tertiary Education | 17 Participants |
| Gaming Experience: Yes, No No | 13 Participants |
| Gaming Experience: Yes, No Yes | 19 Participants |
| Handedness Left | 2 Participants |
| Handedness Right | 30 Participants |
| Involved Side: Left, Right Left | 14 Participants |
| Involved Side: Left, Right Right | 18 Participants |
| Nature of Stroke: Infarct, Haemorrhage Haemorrhage | 20 Participants |
| Nature of Stroke: Infarct, Haemorrhage Infarct | 12 Participants |
| Post Stroke Duration, Continuous | 320.50 days |
| Race/Ethnicity, Customized Chinese | 27 Participants |
| Race/Ethnicity, Customized Indian | 1 Participants |
| Race/Ethnicity, Customized Malay | 2 Participants |
| Race/Ethnicity, Customized Others | 2 Participants |
| Region of Enrollment Singapore | 32 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 21 Participants |
| Side of Stroke: Left, Right, Bilateral Bilateral | 2 Participants |
| Side of Stroke: Left, Right, Bilateral Left | 16 Participants |
| Side of Stroke: Left, Right, Bilateral Right | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 35 |
| other Total, other adverse events | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 |
Outcome results
Primary
10 Meter Walk Test
Measures walking speed as participant walked on a flat ground walking track of 10 metres. Walking speed is calcuated by dividing 10 metres over time taken by a stopwatch. Faster walking speed indicates a better outcome. There is no lower and upper walking speed limits set for this measure.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Jintronix Intervention | 10 Meter Walk Test | 0.71 meters/second | Standard Deviation 0.42 |
Primary
10 Meter Walk Test
Measures walking speed as participant walked on a flat ground walking track of 10 metres. Walking speed is calcuated by dividing 10 metres over time taken by a stopwatch. Faster walking speed indicates a better outcome. There is no lower and upper walking speed limits set for this measure.
Time frame: Week 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Jintronix Intervention | 10 Meter Walk Test | 0.74 meters/second | Standard Deviation 0.47 |
Primary
10 Meter Walk Test
Measures walking speed as participant walked on a flat ground walking track of 10 metres. Walking speed is calcuated by dividing 10 metres over time taken by a stopwatch. Faster walking speed indicates a better outcome. There is no lower and upper walking speed limits set for this measure.
Time frame: Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Jintronix Intervention | 10 Meter Walk Test | 0.76 meters/second | Standard Deviation 0.51 |
Primary
10 Meter Walk Test
Measures walking speed as participant walked on a flat ground walking track of 10 metres. Walking speed is calcuated by dividing 10 metres over time taken by a stopwatch. Faster walking speed indicates a better outcome. There is no lower and upper walking speed limits set for this measure.
Time frame: Week 11
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Jintronix Intervention | 10 Meter Walk Test | 0.78 meters/second | Standard Deviation 0.52 |
Primary
6 Minute Walk Test
Measures endurance inferred from distance measured directly via distance markers placed on ground, as the participant walked up and down repeatedly on a flat ground walking track for a duration of 6 minutes. Higher distance covered by participant in this 6 minutes indicates a better outcome of higher endurance. There is no lower and upper distance limits set for this measure.
Time frame: Week 11
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Jintronix Intervention | 6 Minute Walk Test | 250.78 meters | Standard Deviation 158.95 |
Primary
6 Minute Walk Test
Measures endurance inferred from distance measured directly via distance markers placed on ground, as the participant walked up and down repeatedly on a flat ground walking track for a duration of 6 minutes. Higher distance covered by participant in this 6 minutes indicates a better outcome of higher endurance. There is no lower and upper distance limits set for this measure.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Jintronix Intervention | 6 Minute Walk Test | 206.23 meters | Standard Deviation 129.38 |
Primary
6 Minute Walk Test
Measures endurance inferred from distance measured directly via distance markers placed on ground, as the participant walked up and down repeatedly on a flat ground walking track for a duration of 6 minutes. Higher distance covered by participant in this 6 minutes indicates a better outcome of higher endurance. There is no lower and upper distance limits set for this measure.
Time frame: Week 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Jintronix Intervention | 6 Minute Walk Test | 227.67 meters | Standard Deviation 144.46 |
Primary
6 Minute Walk Test
Measures endurance inferred from distance measured directly via distance markers placed on ground, as the participant walked up and down repeatedly on a flat ground walking track for a duration of 6 minutes. Higher distance covered by participant in this 6 minutes indicates a better outcome of higher endurance. There is no lower and upper distance limits set for this measure.
Time frame: Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Jintronix Intervention | 6 Minute Walk Test | 239.83 meters | Standard Deviation 148.56 |
Primary
Berg Balance Scale
Measures static and dynamic balance abilities. Range of scores from 0-56 points. Total score of 56 points with higher scores indicating better balance functions.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Jintronix Intervention | Berg Balance Scale | 43.34 score on a scale | Standard Deviation 9.99 |
Primary
Berg Balance Scale
Measures static and dynamic balance abilities. Range of scores from 0-56 points. Total score of 56 points with higher scores indicating better balance functions.
Time frame: Week 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Jintronix Intervention | Berg Balance Scale | 47.17 score on a scale | Standard Deviation 8.64 |
Primary
Berg Balance Scale
Measures static and dynamic balance abilities. Range of scores from 0-56 points. Total score of 56 points with higher scores indicating better balance functions.
Time frame: Week 11
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Jintronix Intervention | Berg Balance Scale | 48.59 score on a scale | Standard Deviation 8.97 |
Primary
Berg Balance Scale Score
Measures static and dynamic balance abilities. Range of scores from 0-56 points. Total score of 56 points with higher scores indicating better balance functions.
Time frame: Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Jintronix Intervention | Berg Balance Scale Score | 47.59 score on a scale | Standard Deviation 9.53 |
Primary
Fugl Meyer Upper Limb Motor Assessment
Measures motor impairment of upper limb recovery from a neurological insult. Range of scores from 0-66 points. Total score of 66 points with higher scores indicating better arm motor functions.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Jintronix Intervention | Fugl Meyer Upper Limb Motor Assessment | 36.52 score on a scale | Standard Deviation 16.55 |
Primary
Fugl Meyer Upper Limb Motor Assessment
Measures motor impairment of upper limb recovery from a neurological insult. Range of scores from 0-66 points. Total score of 66 points with higher scores indicating better arm motor functions.
Time frame: Week 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Jintronix Intervention | Fugl Meyer Upper Limb Motor Assessment | 38.48 score on a scale | Standard Deviation 16.55 |
Primary
Fugl Meyer Upper Limb Motor Assessment
Measures motor impairment of upper limb recovery from a neurological insult. Range of scores from 0-66 points. Total score of 66 points with higher scores indicating better arm motor functions.
Time frame: Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Jintronix Intervention | Fugl Meyer Upper Limb Motor Assessment | 39.17 score on a scale | Standard Deviation 16.2 |
Primary
Fugl Meyer Upper Limb Motor Assessment
Measures motor impairment of upper limb recovery from a neurological insult. Range of scores from 0-66 points. Total score of 66 points with higher scores indicating better arm motor functions.
Time frame: Week 11
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Jintronix Intervention | Fugl Meyer Upper Limb Motor Assessment | 40.00 score on a scale | Standard Deviation 16.7 |
Primary
Numerical Pain Score
Measures pain subjectively from participant's rating. Scale is from 0 (indicating no pain experienced) to 10 (indicating worst pain experienced).
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Jintronix Intervention | Numerical Pain Score | 0.10 score on a scale | Standard Deviation 0.41 |
Primary
Numerical Pain Score
Measures pain subjectively from participant's rating. Scale is from 0 (indicating no pain experienced) to 10 (indicating worst pain experienced).
Time frame: Week 3
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Jintronix Intervention | Numerical Pain Score | 0.103 score on a scale |
Primary
Numerical Pain Score
Measures pain subjectively from participant's rating. Scale is from 0 (indicating no pain experienced) to 10 (indicating worst pain experienced).
Time frame: Week 7
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Jintronix Intervention | Numerical Pain Score | 0.000 score on a scale |
Primary
Numerical Pain Score
Measures pain subjectively from participant's rating. Scale is from 0 (indicating no pain experienced) to 10 (indicating worst pain experienced).
Time frame: Week 11
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Jintronix Intervention | Numerical Pain Score | -0.103 score on a scale |
Primary
Stroke Self-Efficacy Questionnaire
Measures a stroke survivor's perceived level of confidence in functional performance. Each of the 13 questions is scored on a 10-point scale (i.e. 0-10) with 0 indicating Not At All Confident and 10 indicating Very Confident. The points from the 13 questions are then added to get a total score, with a minimum score of 0 and a maximum score of 130. Higher score reflects a better outcome.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Jintronix Intervention | Stroke Self-Efficacy Questionnaire | 80.79 score on a scale | Standard Deviation 19.3 |
Primary
Stroke Self-Efficacy Questionnaire
Measures a stroke survivor's perceived level of confidence in functional performance. Each of the 13 questions is scored on a 10-point scale (i.e. 0-10) with 0 indicating Not At All Confident and 10 indicating Very Confident. The points from the 13 questions are then added to get a total score, with a minimum score of 0 and a maximum score of 130. Higher score reflects a better outcome.
Time frame: Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Jintronix Intervention | Stroke Self-Efficacy Questionnaire | 91.79 score on a scale | Standard Deviation 20.11 |
Primary
Stroke Self-Efficacy Questionnaire
Measures a stroke survivor's perceived level of confidence in functional performance. Each of the 13 questions is scored on a 10-point scale (i.e. 0-10) with 0 indicating Not At All Confident and 10 indicating Very Confident. The points from the 13 questions are then added to get a total score, with a minimum score of 0 and a maximum score of 130. Higher score reflects a better outcome..
Time frame: Week 11
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Jintronix Intervention | Stroke Self-Efficacy Questionnaire | 93.59 score on a scale | Standard Deviation 20.49 |