Ablelite Pediatric Device Clinical Study

Study Overview
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Brief Summary
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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.

Official Title
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Ablelite Pediatric Device Clinical Study

Conditions
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Muscular Dystrophies

Intervention / Treatment
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* Device: AbleLite


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects between 9 and 18 years of age, with pediatric onset of neuromuscular conditions that cause quadriparesis MMT score of 1-3 in the elbow, wrist and hands, and an MMT score of 2- to 3 in the shoulder Ability of subject to raise their forearm off of their lap or laptray Willingness to comply and participate with the study protocol and attend the study sessions Ability to communicate verbally and respond to questions and commands Ability to provide informed consent Selected for participation based on investigator discretion Exclusion Criteria: Use of ventilator Open wounds or chronic pressure sores on upper extremities, neck, back or torso Significantly unstable upper extremity joints Unhealed bone fractures in the upper extremities Active rotator cuff tear, grade 2 or 3 Surgical fixations limiting full passive range of motion Uncontrolled upper-limb spasticity that significantly limits normal range of motion Uncontrollable pain in the neck, shoulders or upper limbs Ability to fully raise both hands simultaneously above their head with ease Lack passive shoulder abduction of 120 degrees Lack 90 degrees of passive elbow extension Unable to follow instructions Exhibit significant behavioral problems Inability to provide consent

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AbleLite<br>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. | Device: AbleLite<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) |