Loading clinical trials...

Schulze Muscular Dystrophy Ability Clinical Study | Clinical Trials | Clareo Health

UNKNOWNNA

Schulze Muscular Dystrophy Ability Clinical Study

NCT05409079•AbiliTech Medical Inc.

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.

Eligibility

Age

10 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subjects between 10 and 99 years of age, with onset of neuromuscular conditions that cause quadriparesis
•2. 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
•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 invasive 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 as defined by the investigator
•10. Lack passive shoulder abduction of 120 degrees
+4 more criteria

Locations (1)

Gillette Children's

Saint Paul, Minnesota, United States

Key Dates

Start Date

May 26, 2022

Primary Completion Date

June 30, 2023

Completion Date

June 30, 2023

Last Updated

December 5, 2022

Enrollment

ESTIMATED participants

Conditions

Muscular DystrophiesSpinal Muscular AtrophyDuchenne Muscular DystrophyLimb Girdle Muscular DystrophyFSHDCerebral PalsyBecker Muscular Dystrophy

Interventions

Abilitech Assist

DEVICE

Contacts

Chief Executive Officer

CONTACT

833.225.3123 info@abilitechmedical.com

A Study in Participants With Duchenne Muscular Dystrophy Amenable to Exon 44 Skipping to Evaluate the Safety and Efficacy of ENTR-601-44

NCT07037862

Duchenne Muscular Dystrophy (DMD)

View study

RECRUITING

Genetic and Physical Study of Childhood Nerve and Muscle Disorders

NCT01568658

Muscular DystrophiesMuscle Myopathies+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 5, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Schulze Muscular Dystrophy Ability Clinical Study

Inclusion Criteria

Exclusion Criteria

A Study in Participants With Duchenne Muscular Dystrophy Amenable to Exon 44 Skipping to Evaluate the Safety and Efficacy of ENTR-601-44

Genetic and Physical Study of Childhood Nerve and Muscle Disorders

A Study of SGT-003 Gene Therapy in Ambulant Males With Duchenne Muscular Dystrophy (IMPACT DUCHENNE)

A Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy (DMD)

Characterization of New Phenotypes of Patients With Spinal Muscular Atrophy Treated With SMN Restoring Therapy

Long Read Analysis in Spinal Muscular Atrophy - LOREASI