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

NCT04333758 | Completed Results FDA Device

• 1 other identifier: NHG DSRB 2016/00442
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Rehabilitation, Telerehabilitation, Virtual Reality

Outcome Measures

Primary Outcomes (23)

• 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.

  Week 0

• 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.

  Week 3

• 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.

  Week 7

• 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.

  Week 11

• 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.

  Week 0

• 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.

  Week 3

• 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.

  Week 7

• 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.

  Week 11

• 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.

  Week 0

• 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.

  Week 3

• 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.

  Week 7

• 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.

  Week 11

• 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.

  Week 0

• 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.

  Week 3

• 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.

  Week 7

• 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.

  Week 11

• Numerical Pain Score

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

  Week 0

• Numerical Pain Score

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

  Week 3

• Numerical Pain Score

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

  Week 7

• Numerical Pain Score

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

  Week 11

• 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.

  Week 0

• 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.

  Week 7

• 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..

  Week 11

Study Arms (1)

Jintronix Intervention

EXPERIMENTAL

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

Interventions

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.

Also known as: Jintronix

Jintronix Intervention

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead

Study Sites (1)

Centre for Advanced Rehabilitation Therapeutics, Tan Tock Seng Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Results may be affected by participants having concurrent therapy, home exercise programs or other stroke-related treatment whilst undergoing the research, as these factors are not controlled for by this study design.

Results Point of Contact

• Title: Ms Lim Chien Joo
• Organization: Tan Tock Seng Hospital Pte Ltd

Chien_Joo_LIM@ttsh.com.sg

9035249

Study Officials

• Wee Keong Christopher Kuah, MSc

  Tan Tock Seng Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Occupational Therapist

Model Details: Prospective open label study.

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: April 3, 2020
• Study Start: January 5, 2017
• Primary Completion: November 14, 2018
• Study Completion: November 14, 2018
• Last Updated: June 18, 2024
• Results First Posted: June 18, 2024

Record last verified: 2024-05

Locations

SG (1)