Recruiting

Muscular Dystrophy

Sponsor:

AbiliTech Medical Inc.

Code:

NCT05409079

Conditions

Muscular Dystrophies

Spinal Muscular Atrophy

Duchenne Muscular Dystrophy

Limb Girdle Muscular Dystrophy

FSHD

Eligibility Criteria

Sex: All

Age: 10+

Healthy Volunteers: Not accepted

Interventions

Abilitech Assist

Study Details

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.

Conditions

Muscular Dystrophies

Spinal Muscular Atrophy

Duchenne Muscular Dystrophy

Limb Girdle Muscular Dystrophy

FSHD

Study ID

NCT05409079

Start date

May 26, 2022

Status verified date

Dec, 2022

Completion date

Jun 30, 2023

Anticipated

Primary completion date

Jun 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

35 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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 measure

  • Canadian Occupational Performance Measure (COPM) [ Time Frame: Change from Baseline before device intervention (30 days), and after device intervention (60 days) ]
  • Roll Evaluation of Activities of Life (REAL) assessment [ Time Frame: Change from Baseline before device intervention (30 days), and after device intervention (60 days) ]

Central Contacts and Locations

Central contacts

Locations

Gillette Children's

Recruiting

Saint Paul, Minnesota, United States, 55101

Contacts

More Information

Sponsor

AbiliTech Medical Inc.

Last update posted

Dec 5, 2022

Last verified

Dec, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AbiliTech Medical Inc. on 2022-12-05.