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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wee Keong Christopher Kuah, MSc | Tan Tock Seng Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Advanced Rehabilitation Therapeutics, Tan Tock Seng Hospital | Singapore | Singapore |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | There are 3 drop-outs from the study. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Week 0 |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ms Lim Chien Joo | Tan Tock Seng Hospital Pte Ltd | 9035249 | Chien_Joo_LIM@ttsh.com.sg |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 30, 2016 | Nov 11, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Prospective open label study.
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|
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| 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 |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | There are 3 drop-outs from the study. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | There are 3 drop-outs from the study. | Count of Participants | Participants |
|
| Region of Enrollment | There are 3 drop-outs from the study. | Count of Participants | Participants |
|
| Handedness | There are 3 drop-outs from the study. | Count of Participants | Participants |
|
| Education, Customized | There are 3 drop-outs from the study. | Count of Participants | Participants |
|
| Gaming Experience: Yes, No | There are 3 drop-outs from the study. | Count of Participants | Participants |
|
| Post Stroke Duration, Continuous | There are 3 drop-outs from the study. | Median | Inter-Quartile Range | days |
|
| Nature of Stroke: Infarct, Haemorrhage | There are 3 drop-outs from the study. | Count of Participants | Participants |
|
| Side of Stroke: Left, Right, Bilateral | There are 3 drop-outs from the study. | Count of Participants | Participants |
|
| Involved Side: Left, Right | There are 3 drop-outs from the study. | Count of Participants | Participants |
|
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Week 3 |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Week 7 |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Week 11 |
|
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Week 0 |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Week 3 |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Week 7 |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Week 11 |
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| 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. | Posted | Mean | Standard Deviation | meters | Week 0 |
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| 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. | Posted | Mean | Standard Deviation | meters | Week 3 |
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| 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. | Posted | Mean | Standard Deviation | meters | Week 7 |
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| 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. | Posted | Mean | Standard Deviation | meters | Week 11 |
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| 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. | Posted | Mean | Standard Deviation | meters/second | Week 0 |
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| 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. | Posted | Mean | Standard Deviation | meters/second | Week 3 |
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| 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. | Posted | Mean | Standard Deviation | meters/second | Week 7 |
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| 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. | Posted | Mean | Standard Deviation | meters/second | Week 11 |
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| 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). | Posted | Mean | Standard Deviation | score on a scale | Week 0 |
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| 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). | Posted | Mean | 95% Confidence Interval | score on a scale | Week 3 |
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| 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). | Posted | Mean | 95% Confidence Interval | score on a scale | Week 7 |
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| 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). | Posted | Mean | 95% Confidence Interval | score on a scale | Week 11 |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Week 0 |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Week 7 |
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| 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.. | Posted | Mean | Standard Deviation | score on a scale | Week 11 |
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| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |