Status:
UNKNOWN
Schulze Muscular Dystrophy Ability Clinical Study
Lead Sponsor:
AbiliTech Medical Inc.
Collaborating Sponsors:
Richard M. Schulze Family Foundation
Conditions:
Muscular Dystrophies
Spinal Muscular Atrophy
Eligibility:
All Genders
10+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2023
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT05409079
Start Date
May 26 2022
End Date
June 30 2023
Last Update
December 5 2022
Active Locations (1)
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1
Gillette Children's
Saint Paul, Minnesota, United States, 55101