Schulze Muscular Dystrophy Ability Clinical Study

  • days left to enroll
  • participants needed
  • sponsor
    AbiliTech Medical Inc.
Updated on 24 October 2022
range of motion
muscular dystrophy


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.

Condition Muscular Dystrophies, Spinal Muscular Atrophy, Duchenne Muscular Dystrophy, Limb Girdle Muscular Dystrophy, FSHD, Cerebral Palsy, Becker Muscular Dystrophy
Treatment Abilitech Assist
Clinical Study IdentifierNCT05409079
SponsorAbiliTech Medical Inc.
Last Modified on24 October 2022


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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