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COVID inhibited additional home visits for device installation and testing
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This study is a longitudinal, randomized control trial evaluating the use of two commercially available dynamic arm support devices (1) Armon Ayura-Kinova and 2) JAECO WREX) to promote participation in activities of daily living (ADLs) in non-ambulatory individuals with Duchenne muscular dystrophy (DMD) with upper extremity weakness.
This study is a longitudinal, randomized control trial evaluating the use of two commercially available dynamic arm support devices (1) Armon Ayura-Kinova and 2) JAECO WREX) to promote participation in activities of daily living (ADLs) in non-ambulatory individuals with Duchenne muscular dystrophy (DMD) with upper extremity weakness. Up to 30 individuals will be enrolled to participate in this research study, which includes a two-week baseline data collection period, a four-week device trial and a two-week post device data collection period. Participants will be randomly assigned to trial one of the dynamic arm support devices during the four week in-home trial. The ActiGraph GT9x (name of device), a wrist worn activity monitoring device, will be worn during the baseline period, the device trial and the post device data collection period to capture upper extremity (UE) movement patterns. UE performance will be further quantified with use of a physical motor assessment, the Performance of Upper Limb (PUL) assessment and patient reported outcomes. Data gleaned will provide important knowledge and objective results regarding the potential benefit of dynamic arm supports in individuals with DMD with limited functional use of their upper extremities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Armon Ayura (Kinova) | Experimental | Participants will trial the Armon Ayura dynamic arm support. |
|
| JAECO WREX | Experimental | Participants will trial the JAECO Wilmington Robotic EXoskeleton (WREX) dynamic arm support. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Armon Ayura (Kinova) | Device | Actively assisted mechanical arm support (electric powered to balance arm) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Upper Extremity Activity Counts (Movement) Through Actigraphy | Measured through the ActiGraph GT9X wrist worn activity monitoring device: The multi-axis activity monitor measures activity counts that represent movement of the upper extremity. We calculated the average activity counts during testing items with the arm device and testing items without the arm device. We then calculated change scores (average activity counts without the device minus average activity counts with the device). Higher activity counts indicate more effort and more movement during item testing without the device compared to using the device. | Collection of activity counts through the ActiGraph GT9x occurred during testing phase with and without the upper extremity arm device. |
| Change in Upper Extremity Position Through Actigraphy | Measured through the ActiGraph GT9X wrist worn activity monitoring device: The multi-axis activity monitor (gyroscope within the monitor) measures activity counts (movement) per second in the x, y, and z planes. Change in average activity counts (movement) in x, y, and z planes during the 4-week trial period compared to the 2-week baseline period are reported (higher activity counts means more movement during trial). X plane is horizontal movement, y plane is vertical movement, and z plane extends outward from the body. | Collection of activity counts through the ActiGraph GT9x occurs from baseline through the end of the 4-week device trial. |
| Measure | Description | Time Frame |
|---|---|---|
| Goal Attainment Scale (GAS) | The GAS is a personal interview which allows the individual to determine important and personally meaningful goals. Each participant chose three individualized goals to work on and assess at the end of the study. Goal scaling is standardized in order to calculate the extent to which a patient's goals are met.The GAS uses a 5-point rating scale to determine if the goal was not met (-2) up to a greater than expected meeting of the personal goal (+2). A score of 0 indicates the goal was met as anticipated. We report the average change in the score of each goal when the participant uses the trial device. Here we use change scores which range from 0 (performed the same with and without the device) to 4 (participant performed at a greater than expected level with the device). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roxanna M Bendixen, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15260 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Armon Ayura (Kinova) | Participants will trial the Armon Ayura dynamic arm support. Armon Ayura (Kinova): Actively assisted mechanical arm support (electric powered to balance arm) |
| FG001 | JAECO WREX | Participants will trial the JAECO Wilmington Robotic EXoskeleton (WREX) dynamic arm support. JAECO Wrex: Passive mechanical arm support (elastic bands to balance arm) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Armon Ayura (Kinova) | Participants will trial the Armon Ayura dynamic arm support. Armon Ayura (Kinova): Actively assisted mechanical arm support (electric powered to balance arm) |
| BG001 | JAECO WREX |
| 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 | Change in Upper Extremity Activity Counts (Movement) Through Actigraphy | Measured through the ActiGraph GT9X wrist worn activity monitoring device: The multi-axis activity monitor measures activity counts that represent movement of the upper extremity. We calculated the average activity counts during testing items with the arm device and testing items without the arm device. We then calculated change scores (average activity counts without the device minus average activity counts with the device). Higher activity counts indicate more effort and more movement during item testing without the device compared to using the device. | All participants who had completed the testing period while wearing the Actigraph GT9x are reported. All participants were tested, but data are missing due to technology failure or not wearing the ActiGraph during testing. Participants who were not wearing the ActiGraph during testing are not reported. Comparisons between groups (Kinova and WREX) were not analyzed due to small sample sizes in both groups. | Posted | Mean | Standard Deviation | Activity Counts | Collection of activity counts through the ActiGraph GT9x occurred during testing phase with and without the upper extremity arm device. |
For each participant, adverse event data were collected for up to 10 weeks.
Participants were monitored throughout baseline data collection, the 4 week in-home device trial, and 2 weeks following the removal of the arm device. We maintained contact with participants throughout the study and recorded any adverse or serious adverse event.
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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 | Armon Ayura (Kinova) | Participants will trial the Armon Ayura dynamic arm support. Armon Ayura (Kinova): Actively assisted mechanical arm support (electric powered to balance arm) |
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Coronavirus disease 2019 (COVID) occurred during recruitment and testing, which required us to terminate the trial early before achieving full recruitment. Technical problems with the accelerometer (Actigraph GT9x) led to missing data. At times testing occurred when the participant was not wearing the accelerometer, also leading to missing data. Sample sizes were therefore too small to compute p values or provide any comparative data (between devices). Therefore, change scores were recorded.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roxanna M. Bendixen, Principal Investigator | University of Pittsburgh | 4123836603 | bendixen@pitt.edu |
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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 | Mar 19, 2020 | Jan 25, 2022 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D020388 | Muscular Dystrophy, Duchenne |
| ID | Term |
|---|---|
| D009136 | Muscular Dystrophies |
| D020966 | Muscular Disorders, Atrophic |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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Participants will be randomly assigned to trial a dynamic arm support (Armon Ayura (Kinova) or JAECO WREX)
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| JAECO Wrex | Device | Passive mechanical arm support (elastic bands to balance arm) |
|
| The GAS is completed and scored at baseline and at the end of the 4 week trial with and without the device. |
Participants will trial the JAECO Wilmington Robotic EXoskeleton (WREX) dynamic arm support.
JAECO Wrex: Passive mechanical arm support (elastic bands to balance arm)
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| 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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| Actigraphy (wrist worn activity monitor) | Baseline data were collected using wrist worn Actigraph GT9x during baseline assessment of upper extremity function without the dynamic arm support device. Data were collected over a 2-week time period and means and standard deviation activity counts were used. Actigraph GT9x provides activity counts which measure movement in all directions. | Data were collected using wrist worn Actigraph GT9x during baseline assessment of upper extremity function without the dynamic arm support device. Data were collected over a 2-week time period and means and standard deviation activity counts were used. Actigraph GT9x provides activity counts which measure movement in all directions. The Actigraph was not worn during baseline testing for some participants, resulting in missing activity count data. Higher activity counts represents more movement. | Mean | Standard Deviation | activity counts |
|
| ID | Title | Description |
|---|
| OG000 | Armon Ayura (Kinova) | Participants will trial the Armon Ayura dynamic arm support. Armon Ayura (Kinova): Actively assisted mechanical arm support (electric powered to balance arm) |
| OG001 | JAECO WREX | Participants will trial the JAECO Wilmington Robotic EXoskeleton (WREX) dynamic arm support. JAECO Wrex: Passive mechanical arm support (elastic bands to balance arm) |
|
|
|
| Primary | Change in Upper Extremity Position Through Actigraphy | Measured through the ActiGraph GT9X wrist worn activity monitoring device: The multi-axis activity monitor (gyroscope within the monitor) measures activity counts (movement) per second in the x, y, and z planes. Change in average activity counts (movement) in x, y, and z planes during the 4-week trial period compared to the 2-week baseline period are reported (higher activity counts means more movement during trial). X plane is horizontal movement, y plane is vertical movement, and z plane extends outward from the body. | All participants who completed the testing period while wearing the Actigraph are reported. Comparisons between groups (Kinova and WREX) were not analyzed due to small sample sizes in both groups. | Posted | Mean | Standard Deviation | Activity Counts | Collection of activity counts through the ActiGraph GT9x occurs from baseline through the end of the 4-week device trial. |
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| Secondary | Goal Attainment Scale (GAS) | The GAS is a personal interview which allows the individual to determine important and personally meaningful goals. Each participant chose three individualized goals to work on and assess at the end of the study. Goal scaling is standardized in order to calculate the extent to which a patient's goals are met.The GAS uses a 5-point rating scale to determine if the goal was not met (-2) up to a greater than expected meeting of the personal goal (+2). A score of 0 indicates the goal was met as anticipated. We report the average change in the score of each goal when the participant uses the trial device. Here we use change scores which range from 0 (performed the same with and without the device) to 4 (participant performed at a greater than expected level with the device). | Participants were included in this analysis if they completed the Goal Attainment Scale (GAS) with and without the use of the arm device (Kinova or WREX). Sample sizes were too small to use statistical analyses for comparisons between groups. | Posted | Mean | Standard Deviation | score on a scale | The GAS is completed and scored at baseline and at the end of the 4 week trial with and without the device. |
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|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | JAECO WREX | Participants will trial the JAECO Wilmington Robotic EXoskeleton (WREX) dynamic arm support. JAECO Wrex: Passive mechanical arm support (elastic bands to balance arm) | 0 | 6 | 0 | 6 | 0 | 6 |
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| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D040181 | Genetic Diseases, X-Linked |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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| Average z axis change score |
|
Counts from each axis (x, y, z) were measured across baseline and during the 4-week trial to explore arm movement and positioning during the use of an upper extremity arm device. Counts (within each participant) were summed. A change score from trial minus baseline was calculated for each axis. We provide an average change score and standard deviation across participants with Kinova and participants with WREX.
| Goal 3 |
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