Status:
UNKNOWN
Ablelite Pediatric Device Clinical Study
Lead Sponsor:
AbiliTech Medical Inc.
Collaborating Sponsors:
Gillette Children's Specialty Healthcare
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Muscular Dystrophies
Eligibility:
All Genders
9-18 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04308447
Start Date
July 1 2020
End Date
January 31 2021
Last Update
March 16 2020
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