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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Condition or disease | Intervention/treatment | Phase |
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Muscular Dystrophies Spinal Muscular Atrophy Duchenne Muscular Dystrophy Limb Girdle Muscular Dystrophy FSHD Cerebral Palsy Becker Muscular Dystrophy | Device: Abilitech Assist | Not Applicable |
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 |
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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.
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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. |
- 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.
- 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 |
Inclusion Criteria:
- 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 Criteria:
- 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
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
Contact: Chief Executive Officer | 833.225.3123 | info@abilitechmedical.com |
United States, Minnesota | |
Gillette Children's | Recruiting |
Saint Paul, Minnesota, United States, 55101 | |
Contact: Research research@gillettechildrens.com |
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 |
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 |
Muscular Dystrophies Muscular Dystrophy, Duchenne 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 |