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Ablelite Pediatric Device Clinical Study

Primary Purpose

Muscular Dystrophies

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
AbleLite
Sponsored by
AbiliTech Medical Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscular Dystrophies

Eligibility Criteria

9 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subjects between 9 and 18 years of age, with pediatric onset of neuromuscular conditions that cause quadriparesis
  2. MMT score of 1-3 in the elbow, wrist and hands, and an MMT score of 2- to 3 in the shoulder
  3. Ability of subject to raise their forearm off of their lap or laptray
  4. Willingness to comply and participate with the study protocol and attend the study sessions
  5. Ability to communicate verbally and respond to questions and commands
  6. Ability to provide informed consent
  7. Selected for participation based on investigator discretion

Exclusion Criteria:

  1. Use of ventilator
  2. Open wounds or chronic pressure sores on upper extremities, neck, back or torso
  3. Significantly unstable upper extremity joints
  4. Unhealed bone fractures in the upper extremities
  5. Active rotator cuff tear, grade 2 or 3
  6. Surgical fixations limiting full passive range of motion
  7. Uncontrolled upper-limb spasticity that significantly limits normal range of motion
  8. Uncontrollable pain in the neck, shoulders or upper limbs
  9. Ability to fully raise both hands simultaneously above their head with ease
  10. Lack passive shoulder abduction of 120 degrees
  11. Lack 90 degrees of passive elbow extension
  12. Unable to follow instructions
  13. Exhibit significant behavioral problems
  14. Inability to provide consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    AbleLite

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 22, 2020
    Last Updated
    March 11, 2020
    Sponsor
    AbiliTech Medical Inc.
    Collaborators
    Gillette Children's Specialty Healthcare, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04308447
    Brief Title
    Ablelite Pediatric Device Clinical Study
    Official Title
    Ablelite Pediatric Device Clinical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 1, 2020 (Anticipated)
    Primary Completion Date
    December 31, 2020 (Anticipated)
    Study Completion Date
    January 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    AbiliTech Medical Inc.
    Collaborators
    Gillette Children's Specialty Healthcare, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Device Product Not Approved or Cleared by U.S. FDA
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Muscular Dystrophies

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    AbleLite
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    AbleLite
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Canadian Occupational Performance Measure (COPM)
    Description
    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.
    Time Frame
    Change from Baseline before device intervention (30 days), and after device intervention (60 days)
    Title
    Roll Evaluation of Activities of Life (REAL) assessment
    Description
    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.
    Time Frame
    Change from Baseline before device intervention (30 days), and after device intervention (60 days)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    9 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Director of Clinical and Product Management
    Phone
    833.225.3123
    Email
    info@abilitechmedical.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Ablelite Pediatric Device Clinical Study

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