Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Virginia | OTHER |
Not provided
Not provided
The University of Virginia (UVA) Director of Neurorehabilitation will lead GRASP randomized, controlled efficacy trials. The study will involve employment of the GRASP system in three one-hour sessions per week over eight weeks by stroke survivors suffering from ongoing hand function impairment.
Testing will involve employment of the GRASP system (glove orthosis, sensor package, and application software) in three one-hour sessions per week over eight weeks by stroke survivors suffering from ongoing hand function impairment. This frequency and duration is consistent with previous studies successfully investigating new upper extremity (UE) therapies. The primary outcome of the efficacy study will be change in hand function for a group of participants using the GRASP system versus a control group receiving standard care over the same period.
Participants assigned to the GRASP intervention group will attend five outpatient clinic visits for consent, pre-assessment, and familiarization with the system, followed by an initial home visit and eight weeks (3x per week) of independent at-home practice. In this study period, GRASP intervention group participants will employ the instrumented glove orthosis while performing functional tasks within virtual activities of daily living (ADLs).
Participants in the Usual Care Treatment (UCT) control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as UCT control group participants.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GRASP Intervention | Experimental | This arm will perform eight weeks of independent home practice for upper extremity therapy using the GRASP system. |
|
| Control | Active Comparator | Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as control group participants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GRASP HEP | Device | The GRASP system comprises a sensor package and therapy game software that works with a commercial glove orthosis to enable virtual world-based practice of activities of daily living (ADLs) involving the hand. |
| Measure | Description | Time Frame |
|---|---|---|
| Pre Intervention Fugl-Meyer Assessment of Upper Extremity Motor Function (FMUE) | FMUE is one of the most widely used and accepted quantitative measures of motor function in stroke patients, used in clinical and research settings. Individual patient movements associated with specific motor functions are scored using a 3-point ordinal scale (0, 1, or 2). The study employs a subscale of the full assessment that incorporates 33 items relevant to shoulder, elbow, forearm, wrist, hand, and grasp function, thus creating a possible range of 0 to 66 points. Higher scores correspond to higher levels of motor function. | Pre-intervention at Baseline |
| Post Intervention Fugl-Meyer Assessment of Upper Extremity Motor Function (FMUE) | FMUE is one of the most widely used and accepted quantitative measures of motor function in stroke patients, used in clinical and research settings. Individual patient movements associated with specific motor functions are scored using a 3-point ordinal scale (0, 1, or 2). The study employs a subscale of the full assessment that incorporates 33 items relevant to shoulder, elbow, forearm, wrist, hand, and grasp function, thus creating a possible range of 0 to 66 points. Higher scores correspond to higher levels of motor function. | Post Intervention at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pre Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA) | The WMFT test is a functionally-oriented clinical and research instrument. The test consists of 15 motor tasks scored both for time and quality of movement. The WMFT Functional Assessment (WMFT-FA) score is an observational assessment of movement quality and scored using a 6-point ordinal rating scale that ranges from 0 (no use of the affected side attempted) to 5 (normal function). A total WMFT-FA score is calculated by taking the average across all 15 UE tasks. A patient's WMFT-FA score is thus a real number that can range from 0 to 5. An increase in WMFT-FA score implies improved motor function. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
(3) A psychological diagnosis that in the determination of the Principal Investigator could significantly impact subject's participation or that could be aggravated by study participation (Principal Investigator will consult with candidate's personal physician as appropriate); (4) Determination by the Principal Investigator that participation would result in significant agitation or elevated stress; (5) Visual field deficit in either eye that impairs the ability to view the computer monitor; (6) Stiffness or contractures of the muscles, joints, tendons, ligaments, or skin that restricts normal movement; (7) More than mild tone/spasticity (measured on modified Ashworth, 5-point scale); (8) Severe contractures or joint deformities in the fingers; (9) Open wound or infection, severe edema, or excessive swelling which might interfere with wearing the glove; (10) Severe pre-stroke co-morbidities, such as cardiovascular, neurological, orthopedic, or rheumatoid impairments before stroke that may interfere with task performance; (11) Severe sensory deficits from the involved UE; or (12) Hemispatial neglect that impairs the ability to process and perceive visual stimuli provided through the computer monitor.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UVA Outpatient Rehabilitation Clinic | Charlottesville | Virginia | 22901 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36960762 | Derived | Adams RJ, Ellington AL, Kuccera KA, Leaman H, Smithson C, Patrie JT. Telehealth-Guided Virtual Reality for Recovery of Upper Extremity Function Following Stroke. OTJR (Thorofare N J). 2023 Jul;43(3):446-456. doi: 10.1177/15394492231158375. Epub 2023 Mar 24. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | GRASP Intervention | This arm will perform eight weeks of independent home practice for upper extremity therapy using the GRASP system. GRASP HEP: The GRASP system comprises a sensor package and therapy game software that works with a commercial glove orthosis to enable virtual world-based practice of activities of daily living (ADLs) involving the hand. |
| FG001 | Control | Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as control group participants. Usual Care Treatment (UCT): Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as UCT group participants. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | GRASP Intervention | This arm will perform eight weeks of independent home practice for upper extremity therapy using the GRASP system. GRASP HEP: The GRASP system comprises a sensor package and therapy game software that works with a commercial glove orthosis to enable virtual world-based practice of activities of daily living (ADLs) involving the hand. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Pre Intervention Fugl-Meyer Assessment of Upper Extremity Motor Function (FMUE) | FMUE is one of the most widely used and accepted quantitative measures of motor function in stroke patients, used in clinical and research settings. Individual patient movements associated with specific motor functions are scored using a 3-point ordinal scale (0, 1, or 2). The study employs a subscale of the full assessment that incorporates 33 items relevant to shoulder, elbow, forearm, wrist, hand, and grasp function, thus creating a possible range of 0 to 66 points. Higher scores correspond to higher levels of motor function. | Posted | Mean | 95% Confidence Interval | score on a scale | Pre-intervention at Baseline |
|
8 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GRASP Intervention | This arm will perform eight weeks of independent home practice for upper extremity therapy using the GRASP system. GRASP HEP: The GRASP system comprises a sensor package and therapy game software that works with a commercial glove orthosis to enable virtual world-based practice of activities of daily living (ADLs) involving the hand. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Adams | Barron Associates, Inc. | 4348253435 | adams@bainet.com |
Not provided
| 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 | Sep 18, 2020 | Aug 28, 2023 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Intervention group performs therapy using the GRASP system for virtual world-based practice.
Control group follows a Usual Care Treatment (UCT) regimen.
Not provided
Not provided
Investigator administrating assessments will be blinded to subject group assignment.
| Usual Care Treatment (UCT) | Behavioral | Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as UCT group participants. |
|
| Pre-intervention at Baseline |
| Post Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA) | The WMFT test is a functionally-oriented clinical and research instrument. The test consists of 15 motor tasks scored both for time and quality of movement. The WMFT Functional Assessment (WMFT-FA) score is an observational assessment of movement quality and scored using a 6-point ordinal rating scale that ranges from 0 (no use of the affected side attempted) to 5 (normal function). A total WMFT-FA score is calculated by taking the average across all 15 UE tasks. A patient's WMFT-FA score is thus a real number that can range from 0 to 5. An increase in WMFT-FA score implies improved motor function. | Post Intervention at 8 weeks |
| Pre Intervention Wolf Motor Function Test Time (WMFT-TIME) | The WMFT test is a functionally-oriented clinical and research instrument. The test consists of 15 motor tasks scored both for time and quality of movement. WMFT-TIME is a quantitative measure calculated using the average time to complete the tasks. Any time greater than 120 seconds is recorded as 120 seconds. A patient's WMFT-TIME score (average completion time) thus ranges from 0 to 120. A reduction in WMFT-TIME implies improved motor function. | Pre-intervention at Baseline |
| Post Intervention Wolf Motor Function Test Time (WMFT-TIME) | The WMFT test is a functionally-oriented clinical and research instrument. The test consists of 15 motor tasks scored both for time and quality of movement. WMFT-TIME is a quantitative measure calculated using the average time to complete the tasks. Any time greater than 120 seconds is recorded as 120 seconds. A patient's WMFT-TIME score (average completion time) thus ranges from 0 to 120. A reduction in WMFT-TIME implies improved motor function. | Post Intervention at 8 weeks |
| Pre Intervention Box and Blocks Test (BBT) | The BBT provides a measure of unilateral gross manual dexterity. Subjects are asked to move 2.5 cm wooden cubes from one 8.5 cm tall box to another, as quickly as possible. The BBT score is simply the number of blocks moved in 60 seconds. A patient's WMFT-FA score is thus an integer number if blocks that is greater than or equal to zero. The maximum number of blocks is 150. An increase in BBT score implies improved motor function. | Pre-intervention at Baseline |
| Post Intervention Box and Blocks Test (BBT) | The BBT provides a measure of unilateral gross manual dexterity. Subjects are asked to move 2.5 cm wooden cubes from one 8.5 cm tall box to another, as quickly as possible. The BBT score is simply the number of blocks moved in 60 seconds. A patient's WMFT-FA score is thus an integer number if blocks that is greater than or equal to zero. The maximum number of blocks is 150. An increase in BBT score implies improved motor function. | Post Intervention at 8 weeks |
| Pre Intervention Motor Activity Log - Amount (MAL-Amount) | The MAL is a structured interview assessing use of the affected arm in 30 daily activities in the subject's real-life experience. These range from turning on a light to eating finger foods. For each activity, the subject provides a self-assessment of the frequency with which the affected arm is involved in the activity (MAL-Amount) and the quality with which the affected arm performs (MAL-How Well). Grading is on a Likert scale. At the low end, 0 corresponds to never using the weaker arm for the activity. On the upper end, 5 corresponds to using the weaker arm equivalently to the stronger arm. A total MAL-Amount score is calculated by taking the average across all 30 activities. Likewise, a total MAL-How Well score is calculated by taking the average across all 30 activities. A patient's MAL-Amount and MAL-How Well scores are thus real numbers that can range from 0 to 5. An increase in these scores implies improved motor function. | Pre-intervention at Baseline |
| Post Intervention Motor Activity Log - Amount (MAL-Amount) | The MAL is a structured interview assessing use of the affected arm in 30 daily activities in the subject's real-life experience. These range from turning on a light to eating finger foods. For each activity, the subject provides a self-assessment of the frequency with which the affected arm is involved in the activity (MAL-Amount) and the quality with which the affected arm performs (MAL-How Well). Grading is on a Likert scale. At the low end, 0 corresponds to never using the weaker arm for the activity. On the upper end, 5 corresponds to using the weaker arm equivalently to the stronger arm. A total MAL-Amount score is calculated by taking the average across all 30 activities. Likewise, a total MAL-How Well score is calculated by taking the average across all 30 activities. A patient's MAL-Amount and MAL-How Well scores are thus real numbers that can range from 0 to 5. An increase in these scores implies improved motor function. | Post Intervention at 8 weeks |
| Pre Intervention Motor Activity Log - How Well (MAL-How Well) | The MAL is a structured interview assessing use of the affected arm in 30 daily activities in the subject's real-life experience. These range from turning on a light to eating finger foods. For each activity, the subject provides a self-assessment of the frequency with which the affected arm is involved in the activity (MAL-Amount) and the quality with which the affected arm performs (MAL-How Well). Grading is on a Likert scale. At the low end, 0 corresponds to never using the weaker arm for the activity. On the upper end, 5 corresponds to using the weaker arm equivalently to the stronger arm. A total MAL-Amount score is calculated by taking the average across all 30 activities. Likewise, a total MAL-How Well score is calculated by taking the average across all 30 activities. A patient's MAL-Amount and MAL-How Well scores are thus real numbers that can range from 0 to 5. An increase in these scores implies improved motor function. | Pre-intervention at Baseline |
| Post Intervention Motor Activity Log - How Well (MAL-How Well) | The MAL is a structured interview assessing use of the affected arm in 30 daily activities in the subject's real-life experience. These range from turning on a light to eating finger foods. For each activity, the subject provides a self-assessment of the frequency with which the affected arm is involved in the activity (MAL-Amount) and the quality with which the affected arm performs (MAL-How Well). Grading is on a Likert scale. At the low end, 0 corresponds to never using the weaker arm for the activity. On the upper end, 5 corresponds to using the weaker arm equivalently to the stronger arm. A total MAL-Amount score is calculated by taking the average across all 30 activities. Likewise, a total MAL-How Well score is calculated by taking the average across all 30 activities. A patient's MAL-Amount and MAL-How Well scores are thus real numbers that can range from 0 to 5. An increase in these scores implies improved motor function. | Post Intervention at 8 weeks |
| BG001 |
| Control |
Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as control group participants. Usual Care Treatment (UCT): Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as UCT group participants. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control | Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as control group participants. Usual Care Treatment (UCT): Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as UCT group participants. |
|
|
| Primary | Post Intervention Fugl-Meyer Assessment of Upper Extremity Motor Function (FMUE) | FMUE is one of the most widely used and accepted quantitative measures of motor function in stroke patients, used in clinical and research settings. Individual patient movements associated with specific motor functions are scored using a 3-point ordinal scale (0, 1, or 2). The study employs a subscale of the full assessment that incorporates 33 items relevant to shoulder, elbow, forearm, wrist, hand, and grasp function, thus creating a possible range of 0 to 66 points. Higher scores correspond to higher levels of motor function. | Posted | Mean | 95% Confidence Interval | score on a scale | Post Intervention at 8 weeks |
|
|
|
| Secondary | Pre Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA) | The WMFT test is a functionally-oriented clinical and research instrument. The test consists of 15 motor tasks scored both for time and quality of movement. The WMFT Functional Assessment (WMFT-FA) score is an observational assessment of movement quality and scored using a 6-point ordinal rating scale that ranges from 0 (no use of the affected side attempted) to 5 (normal function). A total WMFT-FA score is calculated by taking the average across all 15 UE tasks. A patient's WMFT-FA score is thus a real number that can range from 0 to 5. An increase in WMFT-FA score implies improved motor function. | Posted | Mean | 95% Confidence Interval | score on a scale | Pre-intervention at Baseline |
|
|
|
| Secondary | Post Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA) | The WMFT test is a functionally-oriented clinical and research instrument. The test consists of 15 motor tasks scored both for time and quality of movement. The WMFT Functional Assessment (WMFT-FA) score is an observational assessment of movement quality and scored using a 6-point ordinal rating scale that ranges from 0 (no use of the affected side attempted) to 5 (normal function). A total WMFT-FA score is calculated by taking the average across all 15 UE tasks. A patient's WMFT-FA score is thus a real number that can range from 0 to 5. An increase in WMFT-FA score implies improved motor function. | Posted | Mean | 95% Confidence Interval | score on a scale | Post Intervention at 8 weeks |
|
|
|
| Secondary | Pre Intervention Wolf Motor Function Test Time (WMFT-TIME) | The WMFT test is a functionally-oriented clinical and research instrument. The test consists of 15 motor tasks scored both for time and quality of movement. WMFT-TIME is a quantitative measure calculated using the average time to complete the tasks. Any time greater than 120 seconds is recorded as 120 seconds. A patient's WMFT-TIME score (average completion time) thus ranges from 0 to 120. A reduction in WMFT-TIME implies improved motor function. | Posted | Mean | 95% Confidence Interval | score on a scale | Pre-intervention at Baseline |
|
|
|
| Secondary | Post Intervention Wolf Motor Function Test Time (WMFT-TIME) | The WMFT test is a functionally-oriented clinical and research instrument. The test consists of 15 motor tasks scored both for time and quality of movement. WMFT-TIME is a quantitative measure calculated using the average time to complete the tasks. Any time greater than 120 seconds is recorded as 120 seconds. A patient's WMFT-TIME score (average completion time) thus ranges from 0 to 120. A reduction in WMFT-TIME implies improved motor function. | Posted | Mean | 95% Confidence Interval | score on a scale | Post Intervention at 8 weeks |
|
|
|
| Secondary | Pre Intervention Box and Blocks Test (BBT) | The BBT provides a measure of unilateral gross manual dexterity. Subjects are asked to move 2.5 cm wooden cubes from one 8.5 cm tall box to another, as quickly as possible. The BBT score is simply the number of blocks moved in 60 seconds. A patient's WMFT-FA score is thus an integer number if blocks that is greater than or equal to zero. The maximum number of blocks is 150. An increase in BBT score implies improved motor function. | Posted | Mean | 95% Confidence Interval | blocks | Pre-intervention at Baseline |
|
|
|
| Secondary | Post Intervention Box and Blocks Test (BBT) | The BBT provides a measure of unilateral gross manual dexterity. Subjects are asked to move 2.5 cm wooden cubes from one 8.5 cm tall box to another, as quickly as possible. The BBT score is simply the number of blocks moved in 60 seconds. A patient's WMFT-FA score is thus an integer number if blocks that is greater than or equal to zero. The maximum number of blocks is 150. An increase in BBT score implies improved motor function. | Posted | Mean | 95% Confidence Interval | blocks | Post Intervention at 8 weeks |
|
|
|
| Secondary | Pre Intervention Motor Activity Log - Amount (MAL-Amount) | The MAL is a structured interview assessing use of the affected arm in 30 daily activities in the subject's real-life experience. These range from turning on a light to eating finger foods. For each activity, the subject provides a self-assessment of the frequency with which the affected arm is involved in the activity (MAL-Amount) and the quality with which the affected arm performs (MAL-How Well). Grading is on a Likert scale. At the low end, 0 corresponds to never using the weaker arm for the activity. On the upper end, 5 corresponds to using the weaker arm equivalently to the stronger arm. A total MAL-Amount score is calculated by taking the average across all 30 activities. Likewise, a total MAL-How Well score is calculated by taking the average across all 30 activities. A patient's MAL-Amount and MAL-How Well scores are thus real numbers that can range from 0 to 5. An increase in these scores implies improved motor function. | Posted | Mean | 95% Confidence Interval | score on a scale | Pre-intervention at Baseline |
|
|
|
| Secondary | Post Intervention Motor Activity Log - Amount (MAL-Amount) | The MAL is a structured interview assessing use of the affected arm in 30 daily activities in the subject's real-life experience. These range from turning on a light to eating finger foods. For each activity, the subject provides a self-assessment of the frequency with which the affected arm is involved in the activity (MAL-Amount) and the quality with which the affected arm performs (MAL-How Well). Grading is on a Likert scale. At the low end, 0 corresponds to never using the weaker arm for the activity. On the upper end, 5 corresponds to using the weaker arm equivalently to the stronger arm. A total MAL-Amount score is calculated by taking the average across all 30 activities. Likewise, a total MAL-How Well score is calculated by taking the average across all 30 activities. A patient's MAL-Amount and MAL-How Well scores are thus real numbers that can range from 0 to 5. An increase in these scores implies improved motor function. | Posted | Mean | 95% Confidence Interval | score on a scale | Post Intervention at 8 weeks |
|
|
|
| Secondary | Pre Intervention Motor Activity Log - How Well (MAL-How Well) | The MAL is a structured interview assessing use of the affected arm in 30 daily activities in the subject's real-life experience. These range from turning on a light to eating finger foods. For each activity, the subject provides a self-assessment of the frequency with which the affected arm is involved in the activity (MAL-Amount) and the quality with which the affected arm performs (MAL-How Well). Grading is on a Likert scale. At the low end, 0 corresponds to never using the weaker arm for the activity. On the upper end, 5 corresponds to using the weaker arm equivalently to the stronger arm. A total MAL-Amount score is calculated by taking the average across all 30 activities. Likewise, a total MAL-How Well score is calculated by taking the average across all 30 activities. A patient's MAL-Amount and MAL-How Well scores are thus real numbers that can range from 0 to 5. An increase in these scores implies improved motor function. | Posted | Mean | 95% Confidence Interval | score on a scale | Pre-intervention at Baseline |
|
|
|
| Secondary | Post Intervention Motor Activity Log - How Well (MAL-How Well) | The MAL is a structured interview assessing use of the affected arm in 30 daily activities in the subject's real-life experience. These range from turning on a light to eating finger foods. For each activity, the subject provides a self-assessment of the frequency with which the affected arm is involved in the activity (MAL-Amount) and the quality with which the affected arm performs (MAL-How Well). Grading is on a Likert scale. At the low end, 0 corresponds to never using the weaker arm for the activity. On the upper end, 5 corresponds to using the weaker arm equivalently to the stronger arm. A total MAL-Amount score is calculated by taking the average across all 30 activities. Likewise, a total MAL-How Well score is calculated by taking the average across all 30 activities. A patient's MAL-Amount and MAL-How Well scores are thus real numbers that can range from 0 to 5. An increase in these scores implies improved motor function. | Posted | Mean | 95% Confidence Interval | score on a scale | Post Intervention at 8 weeks |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Control | Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as control group participants. Usual Care Treatment (UCT): Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as UCT group participants. | 0 | 9 | 0 | 9 | 0 | 9 |
Not provided
Not provided
Not provided