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The overall objective of the proposed study is to carry out usability and design-evaluation assessments of the BURT robotic device for delivering long-term intervention in stroke survivors. The BURT is an upper extremity robotic device that enables the user to see and feel engaging games that encourage intensive therapy. The investigators intend to recruit up to 10 stroke survivors over the course of the study. Participants will train their arm with the BURT for 18 sessions over approximately 6 weeks then participate in a question/answer formatted discussion with research staff to discuss the usability of the device. The investigators will also assess participant's arm function at baseline and after the training sessions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm motor function retraining with BURT | Experimental | All participants will receive 1 hour sessions, 2-3x/week for 6 weeks (total 18 sessions). Sessions will be organized with 30 minutes of robotic-assisted training and 30 minutes of hands-on training with a research therapist to work on the baseline goals of the subject. Hands-on training will be done with routinely employed techniques in therapy to transfer the skills gained with the robotic device in everyday life activities. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arm motor function retraining with BURT | Device | Intervention will be focused on patients impairments to assess the feasibility of the BURT device to carry-on long interventions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes From Baseline in Fugl-Meyer Upper Extremity Scores | Assessment of upper extremity impairments. Individual items of the scale are summed for a total score ranking from 0 to 66. Higher scores indicate better outcomes. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes From Baseline in Goal Attainment Scale Scores | Standardized measure of goals selection and scaling to calculate the extend to which the participant's goals are met. The Goal Attainment Scale ranges from -2 to +2. Positive scores indicates goals are better than expected, score of 0 indicates goals are met and negative scores indicates goals aren't met. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes From Baseline in Wolf Motor Function Test Scores (Time Subscale) | Assessment of upper-extremity function by the performance time of the Wolf Motor Function Test). The average of the 15 items is reported. The time ranges from 0 to 120 seconds. A decrease in performance time is associated with improved upper-extremity function. | 6 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Rehabilitation Hospital | Boston | Massachusetts | 02129 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm Motor Function Retraining With BURT | All participants will receive 1 hour sessions, 2-3x/week for 6 weeks (total 18 sessions). Sessions will be organized with 30 minutes of robotic-assisted training and 30 minutes of hands-on training with a research therapist to work on the baseline goals of the subject. Hands-on training will be done with routinely employed techniques in therapy to transfer the skills gained with the robotic device in everyday life activities. Arm motor function retraining with BURT: Intervention will be focused on patients impairments to assess the feasibility of the BURT device to carry-on long interventions |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm Motor Function Retraining With BURT | All participants will receive 1 hour sessions, 2-3x/week for 6 weeks (total 18 sessions). Sessions will be organized with 30 minutes of robotic-assisted training and 30 minutes of hands-on training with a research therapist to work on the baseline goals of the subject. Hands-on training will be done with routinely employed techniques in therapy to transfer the skills gained with the robotic device in everyday life activities. Arm motor function retraining with BURT: Intervention will be focused on patients impairments to assess the feasibility of the BURT device to carry-on long interventions |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Changes From Baseline in Fugl-Meyer Upper Extremity Scores | Assessment of upper extremity impairments. Individual items of the scale are summed for a total score ranking from 0 to 66. Higher scores indicate better outcomes. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
We collected information in regard to potential adverse events during the 6 weeks of the study intervention.
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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 | Arm Motor Function Retraining With BURT | All participants will receive 1 hour sessions, 2-3x/week for 6 weeks (total 18 sessions). Sessions will be organized with 30 minutes of robotic-assisted training and 30 minutes of hands-on training with a research therapist to work on the baseline goals of the subject. Hands-on training will be done with routinely employed techniques in therapy to transfer the skills gained with the robotic device in everyday life activities. Arm motor function retraining with BURT: Intervention will be focused on patients impairments to assess the feasibility of the BURT device to carry-on long interventions |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paolo Bonato, PhD | Spaulding Rehabilitation Hospital | 6179526319 | pbonato@partners.org |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 5, 2018 | Jan 10, 2020 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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All participants will receive the same intervention
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| Changes From Baseline in Motor Activity Log Scores |
Use of upper extremity in daily life. The self-reported amount of use is reported on a scale from 0 to 5. A score of zero is assigned when the hemiparetic side is not used during the activity of daily living, a score of 5 is assigned when the hemiparetic side is used as much as before the stroke. The 30 items of the scale are averaged. Higher scores are a sign of better use in daily life. |
| 6 weeks |
| Changes From Baseline in Modified Ashworth Scale Scores | Assessment of muscle tone for upper extremity muscles. Score rank from 0 (no tone) to 4 (no movement possible). Lower scores indicates a better outcome. Tone at the shoulder and elbow were measured | 6 weeks |
| Changes From Baseline in Articulations Range of Motion | Assessment of active arm range of motion with goniometry. Results are reported in degrees and higher ranges include better outcomes. | 6 weeks |
| Changes From Baseline in Manual Muscle Testing Scale Scores | Assessment of arm muscle strength using the manual muscle testing scale ranking from 0 (no contraction) to 10 (maximal strength). Higher scores indicate better outcomes. | 6 weeks |
| Changes From Baseline in Wolf Motor Function Test Scores (FAS Subcale) | Assessment of upper-extremity function with the Functional ability subscale of the Wolf Motor Function Test. The average of the 15 items is reported. Scores ranges from 0 to 5, they rate the quality of the movement performance. 0= do not attempt, up to 5= identical to contralateral side. Higher scores are associated with better movement quality. | 6 weeks |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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| Secondary | Changes From Baseline in Goal Attainment Scale Scores | Standardized measure of goals selection and scaling to calculate the extend to which the participant's goals are met. The Goal Attainment Scale ranges from -2 to +2. Positive scores indicates goals are better than expected, score of 0 indicates goals are met and negative scores indicates goals aren't met. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
| Other Pre-specified | Changes From Baseline in Wolf Motor Function Test Scores (Time Subscale) | Assessment of upper-extremity function by the performance time of the Wolf Motor Function Test). The average of the 15 items is reported. The time ranges from 0 to 120 seconds. A decrease in performance time is associated with improved upper-extremity function. | Posted | Mean | Standard Deviation | Time (seconds) | 6 weeks |
|
|
|
| Other Pre-specified | Changes From Baseline in Motor Activity Log Scores | Use of upper extremity in daily life. The self-reported amount of use is reported on a scale from 0 to 5. A score of zero is assigned when the hemiparetic side is not used during the activity of daily living, a score of 5 is assigned when the hemiparetic side is used as much as before the stroke. The 30 items of the scale are averaged. Higher scores are a sign of better use in daily life. | One study participant did not complete the questionnaire | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
| Other Pre-specified | Changes From Baseline in Modified Ashworth Scale Scores | Assessment of muscle tone for upper extremity muscles. Score rank from 0 (no tone) to 4 (no movement possible). Lower scores indicates a better outcome. Tone at the shoulder and elbow were measured | One study participant did not completed this evaluation | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
| Other Pre-specified | Changes From Baseline in Articulations Range of Motion | Assessment of active arm range of motion with goniometry. Results are reported in degrees and higher ranges include better outcomes. | One study participant did not complete this evaluation | Posted | Mean | Standard Deviation | degrees | 6 weeks |
|
|
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| Other Pre-specified | Changes From Baseline in Manual Muscle Testing Scale Scores | Assessment of arm muscle strength using the manual muscle testing scale ranking from 0 (no contraction) to 10 (maximal strength). Higher scores indicate better outcomes. | One study participant did not completed this evaluation | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
| Other Pre-specified | Changes From Baseline in Wolf Motor Function Test Scores (FAS Subcale) | Assessment of upper-extremity function with the Functional ability subscale of the Wolf Motor Function Test. The average of the 15 items is reported. Scores ranges from 0 to 5, they rate the quality of the movement performance. 0= do not attempt, up to 5= identical to contralateral side. Higher scores are associated with better movement quality. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
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| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| Elbow extensors |
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| Wrist flexors |
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| Wrist extensors |
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| Finger flexors |
|
| Finger extensors |
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| Title | Measurements |
|---|---|
|
| Shoulder ADD |
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| Shoulder IR |
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| Shoulder ER |
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| Elbow Flexion |
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| Elbow extension |
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| Forearm pronation |
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| Forearm supination |
|
| Wrist extension |
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| Wrist flexion |
|
| Ulnar flexion |
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| Radial flexion |
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| Index flexion |
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| Index extension |
|
| Title | Measurements |
|---|---|
|
| Shoulder abductors |
|
| Shoulder internal rotators |
|
| Shoulder external rotators |
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| Elbow flexors |
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| Elbow extensors |
|
| Forearm pronators |
|
| Forearm supinators |
|
| Wrist extension |
|
| Wrist flexion |
|