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Completed

NCT Number: NCT04333758

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Advanced Rehabilitation Therapeutics, Tan Tock Seng Hospital

Singapore

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Jintronix Virtual Reality Telerehabilitation System

Device

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

Primary outcomes

  1. Fugl Meyer Upper Limb Motor Assessment

    Time frame: 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.

  2. Fugl Meyer Upper Limb Motor Assessment

    Time frame: Week 3

    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.

  3. Fugl Meyer Upper Limb Motor Assessment

    Time frame: Week 7

    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.

  4. Fugl Meyer Upper Limb Motor Assessment

    Time frame: Week 11

    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.

  5. Berg Balance Scale

    Time frame: 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.

  6. Berg Balance Scale

    Time frame: Week 3

    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.

  7. Berg Balance Scale Score

    Time frame: 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.

  8. Berg Balance Scale

    Time frame: Week 11

    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.

  9. 6 Minute Walk Test

    Time frame: 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. 6 Minute Walk Test

    Time frame: Week 3

    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.

  11. 6 Minute Walk Test

    Time frame: Week 7

    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.

  12. 6 Minute Walk Test

    Time frame: Week 11

    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.

  13. 10 Meter Walk Test

    Time frame: 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.

  14. 10 Meter Walk Test

    Time frame: Week 3

    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.

  15. 10 Meter Walk Test

    Time frame: Week 7

    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.

  16. 10 Meter Walk Test

    Time frame: Week 11

    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.

  17. Numerical Pain Score

    Time frame: Week 0

    Measures pain subjectively from participant's rating. Scale is from 0 (indicating no pain experienced) to 10 (indicating worst pain experienced).

  18. Numerical Pain Score

    Time frame: Week 3

    Measures pain subjectively from participant's rating. Scale is from 0 (indicating no pain experienced) to 10 (indicating worst pain experienced).

  19. Numerical Pain Score

    Time frame: Week 7

    Measures pain subjectively from participant's rating. Scale is from 0 (indicating no pain experienced) to 10 (indicating worst pain experienced).

  20. Numerical Pain Score

    Time frame: Week 11

    Measures pain subjectively from participant's rating. Scale is from 0 (indicating no pain experienced) to 10 (indicating worst pain experienced).

  21. Stroke Self-Efficacy Questionnaire

    Time frame: 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.

  22. Stroke Self-Efficacy Questionnaire

    Time frame: Week 7

    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.

  23. Stroke Self-Efficacy Questionnaire

    Time frame: Week 11

    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..

Sponsors and collaborators

Lead sponsor

Tan Tock Seng Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 3, 2020
Registry last updated
Jun 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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