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Schulze Muscular Dystrophy Ability Clinical Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05409079
Recruitment Status : Recruiting
First Posted : June 8, 2022
Last Update Posted : December 5, 2022
Sponsor:
Collaborator:
Richard M. Schulze Family Foundation
Information provided by (Responsible Party):
AbiliTech Medical Inc.

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 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 or disease Intervention/treatment Phase
Muscular Dystrophies Spinal Muscular Atrophy Duchenne Muscular Dystrophy Limb Girdle Muscular Dystrophy FSHD Cerebral Palsy Becker Muscular Dystrophy Device: Abilitech Assist Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Schulze Muscular Dystrophy Ability Clinical Study
Actual Study Start Date : May 26, 2022
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023


Arm Intervention/treatment
Experimental: Abilitech Assist
The Abilitech™ Assist device is a passively powered orthotic device designed to support and assist the arms of patients with neuromuscular weakness for activities of daily living.
Device: Abilitech Assist
The Abilitech™ Assist is an externally worn device supported by a body frame, which is designed to support and assist the arms in activities of daily living (ADL's). The Abilitech Assist is comprised of three parts: a modular body vest that adjusts to accommodate different body sizes, a single arm orthosis that attaches to the body vest, and an external power pack and controller for tensioning the arm's internal springs to adjust the arm's level of assist. The device augments a user's native arm function to provide lift assistance. Software customizes the spring tension for the level of assist required. The user can turn the system ON/OFF and toggle and adjust the level of assist (e.g., low, medium or high assist) using a pushbutton controller.




Primary Outcome Measures :
  1. Canadian Occupational Performance Measure (COPM) [ Time Frame: Change from Baseline before device intervention (30 days), and after device intervention (60 days) ]
    The Canadian Occupational Performance Measure is an evidence-based outcome measure designed to capture a client's self-perception of performance in everyday living, over time. The COPM results in two main scores - PERFORMANCE and SATISFACTION - each out of 10. PERFORMANCE and SATISFACTION scores can be generated for up to 5 individual occupational performance problems. Average PERFORMANCE and SATISFACTION scores can be calculated by summing individual problem scores and dividing by the number of problems. Change in scores for both PERFORMANCE and SATISFACTION can be calculated after a reassessment interval and a comparison of individual's score differences from Time 1 (assessment) to Time 2 (re-assessment). Increases in scores indicate improvement in task performance and satisfaction.

  2. Roll Evaluation of Activities of Life (REAL) assessment [ Time Frame: Change from Baseline before device intervention (30 days), and after device intervention (60 days) ]
    The REAL is an instrument to help professionals assess an individuals ability to care for themselves at home, at school and in the community. This assessment includes 136 total items with two domains(ADL: 78 items, IADL:58 items) that are rated using a 4-point scale (0-3) to describe whether an individual is unable, sleds, occasionally, or frequently able to complete a task. Scores are summed for each domain and compared over time with increases in scores indicating improvement in each domain.



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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  11. Lack 90 degrees of passive elbow extension
  12. Unable to follow instructions
  13. Exhibit significant behavioral problems
  14. Inability to provide consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05409079


Contacts
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Contact: Chief Executive Officer 833.225.3123 info@abilitechmedical.com

Locations
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United States, Minnesota
Gillette Children's Recruiting
Saint Paul, Minnesota, United States, 55101
Contact: Research       research@gillettechildrens.com   
Sponsors and Collaborators
AbiliTech Medical Inc.
Richard M. Schulze Family Foundation
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Responsible Party: AbiliTech Medical Inc.
ClinicalTrials.gov Identifier: NCT05409079    
Other Study ID Numbers: Schulze
First Posted: June 8, 2022    Key Record Dates
Last Update Posted: December 5, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Muscular Dystrophy, Duchenne
Muscular Dystrophies
Muscular Dystrophies, Limb-Girdle
Cerebral Palsy
Muscular Atrophy
Muscular Atrophy, Spinal
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Neuromuscular Manifestations
Neurologic Manifestations
Spinal Cord Diseases
Motor Neuron Disease
Neurodegenerative Diseases