Schulze Muscular Dystrophy Ability Clinical Study

Study Identifier:
Schulze
ClinicalTrials.gov Identifier:
NCT05409079
EudraCT Identifier:
N/A
EU CT Number:
N/A
Sponsor:
AbiliTech Medical Inc.
Unmapped

Study Details

Medical Condition
  • All Spinal Muscular Atrophies
Study Drug
    Date
    May 2022 - Jun 2023
    Patient Requirements
    Sex: Female & Male
    Age: 10+ years
    Requirements Information
    Inclusion and Exclusion Criteria
    Inclusion Criteria
    • Subjects between 10 and 99 years of age, with onset of neuromuscular conditions that cause quadriparesis
    • MMT score of 1-3 in the elbow, wrist and hand; and a MMT score of 2-3 in the shoulder of at least one of the subject's arms
    • 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 invasive 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 as defined by the investigator
    • 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

    Protocol Summary

    The primary objective of the Schulze study is to evaluate the function of the upper limbs of subjects diagnosed with neuromuscular disorders, with and without use of the Abilitech Assist 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. Secondary objectives also include characterization of user upper limb performance based on etiology.

    Trial Locations

    Location
    Status
    Location
    Gillette Children's
    Saint Paul, Minnesota, United States, 55101
    Status
    Recruiting

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