Schulze Muscular Dystrophy Ability Clinical Study
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ClinicalTrials.gov Identifier: NCT05409079 |
Recruitment Status :
Recruiting
First Posted : June 8, 2022
Last Update Posted : December 5, 2022
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Sponsor:
AbiliTech Medical Inc.
Collaborator:
Richard M. Schulze Family Foundation
Information provided by (Responsible Party):
AbiliTech Medical Inc.
Tracking Information | |||||||
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First Submitted Date ICMJE | June 3, 2022 | ||||||
First Posted Date ICMJE | June 8, 2022 | ||||||
Last Update Posted Date | December 5, 2022 | ||||||
Actual Study Start Date ICMJE | May 26, 2022 | ||||||
Estimated Primary Completion Date | June 30, 2023 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Schulze Muscular Dystrophy Ability Clinical Study | ||||||
Official Title ICMJE | Schulze Muscular Dystrophy Ability Clinical Study | ||||||
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. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | 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.
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Study Arms ICMJE | 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.
Intervention: Device: Abilitech Assist
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
35 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | June 30, 2023 | ||||||
Estimated Primary Completion Date | June 30, 2023 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 10 Years and older (Child, Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT05409079 | ||||||
Other Study ID Numbers ICMJE | Schulze | ||||||
Has Data Monitoring Committee | Not Provided | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | AbiliTech Medical Inc. | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | AbiliTech Medical Inc. | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Richard M. Schulze Family Foundation | ||||||
Investigators ICMJE | Not Provided | ||||||
PRS Account | AbiliTech Medical Inc. | ||||||
Verification Date | December 2022 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |