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| Name | Class |
|---|---|
| Rancho Research Institute, Inc. | OTHER |
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We will investigate the efficacy of a newly developed exercise device (RehabTouch) for people in the subacute stage after a stroke compared to a traditional tabletop exercise program. RehabTouch uses embedded sensors that can track and record the patient's direction and degree of movement as they perform exercises described on a computer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RehabTouch Exercise Program | Experimental | Participants will perform targetted movement exercises by interacting with the RehabTouch pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks. |
|
| Conventional tabletop exercise program | Active Comparator | Conventional tabletop exercise program is a traditional exercise program described in a booklet similar to what is typical provided to stroke patients upon their discharge from the hospital. Participants will be asked to perform these exercises at least 3 hours per week for 3 consecutive weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RehabTouch | Device | Exercise using the motion sensing devices and a computer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fugl-Meyer Arm Motor Score From Baseline to One Month Post Therapy | The Fugl-Meyer Arm Motor Score is a stroke-specific, performance-based impairment index which measure 33 arm movement patterns based on a scale of 0 to 2 each, for a total possible score of 66. For each movement patter, a score of zero means the participant is unable to perform the movement pattern; a score of 2 means the participant performed the movement patterns faultlessly. | From Baseline to One-month Post-therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Box and Blocks Test Score | The Box & Blocks Test (BBT) score assess hand function and gripping ability by instructing an individual to move as many blocks as possible, one at a time, from one compartment to the other for a period of 60 seconds. The BBT is scored by counting the number of blocks carried over the partition from one compartment to the other during the one-minute trial period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Shaw, MD | Rancho Research Institute, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rancho Research Institute, Inc. | Downey | California | 90242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36636751 | Derived | Swanson VA, Johnson C, Zondervan DK, Bayus N, McCoy P, Ng YFJ, Schindele Bs J, Reinkensmeyer DJ, Shaw S. Optimized Home Rehabilitation Technology Reduces Upper Extremity Impairment Compared to a Conventional Home Exercise Program: A Randomized, Controlled, Single-Blind Trial in Subacute Stroke. Neurorehabil Neural Repair. 2023 Jan;37(1):53-65. doi: 10.1177/15459683221146995. Epub 2023 Jan 12. |
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| ID | Title | Description |
|---|---|---|
| FG000 | RehabTouch Exercise Program | Participants will perform targetted movement exercises by interacting with the RehabTouch pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks. RehabTouch: Exercise using the motion sensing devices and a computer |
| FG001 | Conventional Tabletop Exercise Program | Conventional tabletop exercise program is a traditional exercise program described in a booklet similar to what is typical provided to stroke patients upon their discharge from the hospital. Participants will be asked to perform these exercises at least 3 hours per week for 3 consecutive weeks. Conventional tabletop exercise program: Exercise following printed sheets of exercises |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RehabTouch Exercise Program | Participants will perform targetted movement exercises by interacting with the RehabTouch pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks. RehabTouch: Exercise using the motion sensing devices and a computer |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Fugl-Meyer Arm Motor Score From Baseline to One Month Post Therapy | The Fugl-Meyer Arm Motor Score is a stroke-specific, performance-based impairment index which measure 33 arm movement patterns based on a scale of 0 to 2 each, for a total possible score of 66. For each movement patter, a score of zero means the participant is unable to perform the movement pattern; a score of 2 means the participant performed the movement patterns faultlessly. | Three participants in the conventional therapy group did not perform their one-month follow-up assessment; one of these did perform the end-of-therapy assessment. For this one participant, the missing one-month follow-up data point was imputed for the primary outcome measure by adding the average change in Fugl-Meyer score across all participants in the conventional therapy group from end-of-therapy to one-month follow-up to this participant's end-of-therapy Fugl-Meyer score. | Posted | Mean | Standard Deviation | Score on a Scale | From Baseline to One-month Post-therapy |
|
1 year, 4 months
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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 | RehabTouch Exercise Program | Participants will perform targetted movement exercises by interacting with the RehabTouch pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks. RehabTouch: Exercise using the motion sensing devices and a computer |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Zondervan | Flint Rehabilitation Devices | 9493137322 | dzondervan@flintrehab.com |
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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 31, 2021 | Jan 10, 2022 | Prot_SAP_002.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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| Conventional tabletop exercise program | Other | Exercise following printed sheets of exercises |
|
| From Baseline to One-month Post-therapy |
| 10 Meter Walk Test | The 10MWT assesses walking speed in meters per second over a short duration. | From Baseline to One-month Post-therapy |
| Motor Activity Log | The Motor Activity Log (MAL) is a semi-structured interview to assess arm function after hemiparetic stroke. Individuals are asked to rate Quality of Movement (QOM) and Amount of Movement (AOM) during 28 daily functional tasks on a 0-5 point scale. For the QOM subscale, 0 represents an inability to use the affected arm to perform an activity, while 5 represents a normal ability to use the affected arm. For the AOM scale, 0 represents never using the affected arm to perform the activity, and 5 indicates always using the affected arm to perform the activity. | One-month Post-therapy |
| Visual Analog Pain Scale | A standard analog scale that ranges from 0 to 10 for assessing pain. | From Baseline to One-month Post-therapy |
| Modified Ashworth Spasticity Scale | The Modified Ashworth Spasticity (MAS) Scale measures spasticity in patients with lesions of the Central Nervous System. Tests resistance to passive movement about a joint with varying degrees of velocity, with movements in flexion and extension scored separately. Scores for each movement direction and joint range from 0-5, with 6 choices. A score of 0 indicates no increase in tone during movement. A score of 5 indicates that the limb was rigid during the passive movement. | From Baseline to One-month Post-therapy |
| Conventional Tabletop Exercise Program |
Conventional tabletop exercise program is a traditional exercise program described in a booklet similar to what is typical provided to stroke patients upon their discharge from the hospital. Participants will be asked to perform these exercises at least 3 hours per week for 3 consecutive weeks. Conventional tabletop exercise program: Exercise following printed sheets of exercises |
| 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 |
|
| RehabTouch Exercise Program |
Participants will perform targetted movement exercises by interacting with the RehabTouch pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks. RehabTouch: Exercise using the motion sensing devices and a computer |
| OG001 | Conventional Tabletop Exercise Program | Conventional tabletop exercise program is a traditional exercise program described in a booklet similar to what is typical provided to stroke patients upon their discharge from the hospital. Participants will be asked to perform these exercises at least 3 hours per week for 3 consecutive weeks. Conventional tabletop exercise program: Exercise following printed sheets of exercises |
|
|
|
| Secondary | Change in Box and Blocks Test Score | The Box & Blocks Test (BBT) score assess hand function and gripping ability by instructing an individual to move as many blocks as possible, one at a time, from one compartment to the other for a period of 60 seconds. The BBT is scored by counting the number of blocks carried over the partition from one compartment to the other during the one-minute trial period. | Posted | Mean | Standard Deviation | Boxes | From Baseline to One-month Post-therapy |
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| Secondary | 10 Meter Walk Test | The 10MWT assesses walking speed in meters per second over a short duration. | Posted | Mean | Standard Deviation | meters per second | From Baseline to One-month Post-therapy |
|
|
|
| Secondary | Motor Activity Log | The Motor Activity Log (MAL) is a semi-structured interview to assess arm function after hemiparetic stroke. Individuals are asked to rate Quality of Movement (QOM) and Amount of Movement (AOM) during 28 daily functional tasks on a 0-5 point scale. For the QOM subscale, 0 represents an inability to use the affected arm to perform an activity, while 5 represents a normal ability to use the affected arm. For the AOM scale, 0 represents never using the affected arm to perform the activity, and 5 indicates always using the affected arm to perform the activity. | Posted | Mean | Standard Deviation | Score on a Scale | One-month Post-therapy |
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| Secondary | Visual Analog Pain Scale | A standard analog scale that ranges from 0 to 10 for assessing pain. | Posted | Mean | Standard Deviation | Score on a Scale | From Baseline to One-month Post-therapy |
|
|
|
| Secondary | Modified Ashworth Spasticity Scale | The Modified Ashworth Spasticity (MAS) Scale measures spasticity in patients with lesions of the Central Nervous System. Tests resistance to passive movement about a joint with varying degrees of velocity, with movements in flexion and extension scored separately. Scores for each movement direction and joint range from 0-5, with 6 choices. A score of 0 indicates no increase in tone during movement. A score of 5 indicates that the limb was rigid during the passive movement. | Posted | Mean | Standard Deviation | Score on a Scale | From Baseline to One-month Post-therapy |
|
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| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Conventional Tabletop Exercise Program | Conventional tabletop exercise program is a traditional exercise program described in a booklet similar to what is typical provided to stroke patients upon their discharge from the hospital. Participants will be asked to perform these exercises at least 3 hours per week for 3 consecutive weeks. Conventional tabletop exercise program: Exercise following printed sheets of exercises | 0 | 13 | 0 | 13 | 0 | 13 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |