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| ID | Type | Description | Link |
|---|---|---|---|
| 2R44HD089789-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Gillette Children's Specialty Healthcare | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The primary objective of the AbleLite early feasibility study is to evaluate the function of the upper limbs of participants diagnosed with neuromuscular disorders as children, with and without use of the Abilitech AbleLite device in the clinic and home environments. Functional outcomes will include documenting active range of motion and the ability to perform activities of daily living (ADLs) using the standardized Canadian Occupational Performance Measure (COPM) and the Role Evaluation of Activities of Life (REAL) assessments. Secondary objectives are to assess the safety record and report on adverse events (AEs) and parameters related to device usage, including device usage time and the time required to don/doff the device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AbleLite | Experimental | The AbleLite device is a passively powered orthotic device designed to support and assist the arms of patients with neuromuscular weakness for activities of daily living. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AbleLite | Device | The AbleLite device is a passively powered orthotic device designed to support and assist the arms of patients with neuromuscular weakness for activities of daily living. |
| Measure | Description | Time Frame |
|---|---|---|
| Canadian Occupational Performance Measure (COPM) | The Canadian Occupational Performance Measure is an evidence-based outcome measure designed to capture a client's self-perception of performance in everyday living, over time. | Change from Baseline before device intervention (30 days), and after device intervention (60 days) |
| Roll Evaluation of Activities of Life (REAL) assessment | The REAL is an instrument to help professionals assess a child's ability to care for themselves at home, at school and in the community. | Change from Baseline before device intervention (30 days), and after device intervention (60 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical and Product Management | Contact | 833.225.3123 | info@abilitechmedical.com |
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| ID | Term |
|---|---|
| D009136 | Muscular Dystrophies |
| ID | Term |
|---|---|
| D020966 | Muscular Disorders, Atrophic |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
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| D009422 | Nervous System Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |