Ablelite Pediatric Device Clinical Study

NCT04308447 | Unknown FDA Device

• 2 other identifiers: PR610003-1002R44HD089789-02
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Muscular Dystrophies

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (1)

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.

Device: AbleLite

Interventions

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.

AbleLite

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbiliTech Medical Inc.: lead
• Gillette Children's Specialty Healthcare: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

MeSH Terms

Conditions

Muscular Dystrophies

Condition Hierarchy (Ancestors)

Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Director of Clinical and Product Management

CONTACT

833.225.3123; info@abilitechmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2020
• First Posted: March 16, 2020
• Study Start: July 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: January 31, 2021
• Last Updated: March 16, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share