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| ID | Type | Description | Link |
|---|---|---|---|
| 1R44NS097061-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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This study has 2 parts: In one part of this study, people with stroke will either play a custom designed computer game for stroke rehabilitation called Duck Duck Punch or an off the shelf computer game with their weaker arm 3 times per week for 6 weeks. Evaluations will determine whether or not one computer game improved arm movement more than the other. In the second part of the study, people with stroke, caregivers of people with stroke and stroke rehabilitation therapists will meet in several focus groups to design a useful and informative Duck Duck Punch performance report.
Stroke is a problem nationally, but especially in the southeastern USA, a region known as the "stroke belt" where stroke incidence is high and age of stroke onset is low. The vast majority, >75%, of stroke survivors experience paresis of one arm/hand that does not resolve acutely. Long-term arm movement impairment restricts independence with self-care and vocational activities, increases caregiver burden and reduces quality of life. Although rehabilitation improves outcomes, systematic financial pressures increasingly limit its duration. Unfortunately, this is happening at a time when strong evidence is emerging that traditional therapy programs do not provide adequate amounts of movement practice needed for motor recovery. Thus, there is a need for innovative technology to augment traditional stroke rehabilitation programs in a way that can provide the necessary movement practice within the constraints of current rehabilitation practice.
To meet this need, the Principal Investigators developed a prototype Kinect-based post-stroke rehabilitation game called Duck Duck Punch (DDP). While maintaining the appeal of a game, DDP has a therapeutic focus because its unique design elicits an arm motor recovery process consistent with evidence-based stroke rehabilitation principles. The player moves his/her physical arm to control an avatar arm to reach and "punch" virtual ducks. Custom features allow tailoring of game difficulty to match a player's impairment level so that the player seeks to accomplish optimally challenging movement goals. By design, the avatar does not respond to atypical arm motions, which encourages the player to trial and error a variety of motions until implicitly learning the more normal strategy. Thus, unlike most commercially available "off the shelf" games, success requires "therapist approved" healthy arm motions. Success motivates continued game play for extended practice of healthy motions. Therapists can integrate DDP into in-clinic or in-home therapies for additional quasi-supervised movement practice and receive a performance report that quantifies and monitors progress toward recovery goals. Further development of this report will enable its integration into a billable rehabilitation program.
The Investigators licensed DDP and formed a company, Recovr, which has received investment funding for initial start-up and market research. Of note, DDP has also received FDA 510(k) Clearance to "support physical rehabilitation of adults in the clinic and at home via performance of therapist-assigned reach exercises for the upper extremities." In a funded NIH/NIGMS pilot project, the investigators established the technical merit and feasibility of DDP as a tool to augment inpatient, outpatient and home-based stroke rehabilitation by increasing therapist- and patient-directed movement practice opportunities. Very promising results motivated the current project that seeks to test the functional viability of DDP and determine its commercial potential.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duck Duck Punch | Experimental | Subjects in this arm will engage in Duck Duck Punch Play, a custom designed computer game developed for stroke rehabilitation for 6 weeks. |
|
| Commercially Available Game | Active Comparator | Subjects in this arm will engage in a Commercially Available Game Play off-the-shelf computer game for 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duck Duck Punch Play | Device | The behavioral intervention will include playing a hands-free video game custom designed for stroke survivors. |
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| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Upper Extremity Assessment (FMA-UE) | 33 item measure of upper extremity (UE) motor control impairment. Total scores were analyzed from 0/66 (indicating a severe impairment, no motor control) to 66/66 (indicating a mild impairment, with near normal motor control) | Change from baseline at post 6 weeks of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Wolf Motor Function Test (WMFT) | The Wolf Motor Function Test contains 15 items, each of which measure upper extremity functional ability by recording the time (seconds) required to accomplish the task. High functional ability is evident in quicker performance times near 0 seconds. Low functional ability is evident in slower performance times near 120 seconds. The assessment is scored by recording the time to perform each of the 15 items (0 seconds to 120 seconds per item), then the average item performance time is calculated. A small average item performance time (near 0 seconds) indicates higher functional ability and thus a better outcome. A large average item performance time (near 120 seconds) indicates less functional ability and thus a poorer outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle L Woodbury, PhD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
At the conclusion of the study, de-identified data will be available to other researchers and may be obtained by emailing the PI
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| ID | Title | Description |
|---|---|---|
| FG000 | Duck Duck Punch | Subjects in this arm will engage in Duck Duck Punch Play, a custom designed computer game developed for stroke rehabilitation for 6 weeks. Duck Duck Punch Play: The behavioral intervention will include playing a hands-free video game custom designed for stroke survivors. |
| FG001 | Commercially Available Game | Subjects in this arm will engage in a Commercially Available Game Play off-the-shelf computer game for 6 weeks. Commercially Available Game Play: The behavioral intervention will include playing a hands-free video game available off-the-shelf. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Duck Duck Punch | Subjects in this arm will engage in Duck Duck Punch Play, a custom designed computer game developed for stroke rehabilitation for 6 weeks. Duck Duck Punch Play: The behavioral intervention will include playing a hands-free video game custom designed for stroke survivors. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Fugl-Meyer Upper Extremity Assessment (FMA-UE) | 33 item measure of upper extremity (UE) motor control impairment. Total scores were analyzed from 0/66 (indicating a severe impairment, no motor control) to 66/66 (indicating a mild impairment, with near normal motor control) | Posted | Mean | Standard Deviation | Units on a scale | Change from baseline at post 6 weeks of intervention |
|
Adverse event data were collected throughout the duration of the study a total of 1 year, and 11 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 | Duck Duck Punch | Subjects in this arm will engage in Duck Duck Punch Play, a custom designed computer game developed for stroke rehabilitation for 6 weeks. Duck Duck Punch Play: The behavioral intervention will include playing a hands-free video game custom designed for stroke survivors. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall Unrelated to Study | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle Woodbury | Medical University of South Carolina | 843-792-1671 | woodbuml@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 25, 2018 | Jan 30, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 25, 2018 | Jul 14, 2020 | SAP_001.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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Stroke survivors will either play a custom designed computer game for stroke rehabilitation called Duck Duck Punch or an off the shelf computer game with their weaker arm 3 times per week for 6 weeks. Evaluations will determine whether or not one computer game improved arm movement more than the other.
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Blinded raters perform scoring of all assessments
| Commercially Available Game Play | Behavioral | The behavioral intervention will include playing a hands-free video game available off-the-shelf. |
|
| Change from baseline at post 6 weeks of intervention |
| Kinematic Variable; Shoulder Flexion-elbow Extension Interjoint Coordination | Shoulder flexion-elbow extension interjoint coordination. Correlation between the shoulder flexion and elbow extension joint angles during a forward reach movement. Values range from -1 (indicating an abnormal flexor synergy pattern, i.e. higher impairment) to 1 (indicating movement similar to a healthy individual, i.e. lower impairment). | Change from baseline at post 6 weeks of intervention |
| Kinematic Variable; Trunk Displacement | Displacement of the upper trunk marker during reaching task | Change from baseline at post 6 weeks of intervention |
| Commercially Available Game |
Subjects in this arm will engage in a Commercially Available Game Play off-the-shelf computer game for 6 weeks. Commercially Available Game Play: The behavioral intervention will include playing a hands-free video game available off-the-shelf. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| 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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Subjects in this arm will engage in a Commercially Available Game Play off-the-shelf computer game for 6 weeks.
Commercially Available Game Play: The behavioral intervention will include playing a hands-free video game available off-the-shelf.
|
|
| Secondary | Wolf Motor Function Test (WMFT) | The Wolf Motor Function Test contains 15 items, each of which measure upper extremity functional ability by recording the time (seconds) required to accomplish the task. High functional ability is evident in quicker performance times near 0 seconds. Low functional ability is evident in slower performance times near 120 seconds. The assessment is scored by recording the time to perform each of the 15 items (0 seconds to 120 seconds per item), then the average item performance time is calculated. A small average item performance time (near 0 seconds) indicates higher functional ability and thus a better outcome. A large average item performance time (near 120 seconds) indicates less functional ability and thus a poorer outcome. | Posted | Mean | Standard Deviation | Time (seconds) | Change from baseline at post 6 weeks of intervention |
|
|
|
| Secondary | Kinematic Variable; Shoulder Flexion-elbow Extension Interjoint Coordination | Shoulder flexion-elbow extension interjoint coordination. Correlation between the shoulder flexion and elbow extension joint angles during a forward reach movement. Values range from -1 (indicating an abnormal flexor synergy pattern, i.e. higher impairment) to 1 (indicating movement similar to a healthy individual, i.e. lower impairment). | Posted | Mean | Standard Deviation | Units on a scale | Change from baseline at post 6 weeks of intervention |
|
|
|
| Secondary | Kinematic Variable; Trunk Displacement | Displacement of the upper trunk marker during reaching task | Posted | Mean | Standard Deviation | mm | Change from baseline at post 6 weeks of intervention |
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| 0 |
| 33 |
| 0 |
| 33 |
| 1 |
| 33 |
| EG001 | Commercially Available Game | Subjects in this arm will engage in a Commercially Available Game Play off-the-shelf computer game for 6 weeks. Commercially Available Game Play: The behavioral intervention will include playing a hands-free video game available off-the-shelf. | 0 | 33 | 0 | 33 | 1 | 33 |
| Visit to ER Unrelated to Study | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |