## Protocol Section
### Identification Module
**NCT ID:** NCT05409079

**Brief Title:** Schulze Muscular Dystrophy Ability Clinical Study

**Official Title:** Schulze Muscular Dystrophy Ability Clinical Study

#### Organization Study ID Info
**ID:** Schulze
#### Organization
**Class:** INDUSTRY
**Full Name:** AbiliTech Medical Inc.
### Status Module
#### Completion Date
**Date:** 2023-06-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-12-05

**Type:** ACTUAL

**Last Update Submit Date:** 2022-12-01

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2023-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-05-26

**Type:** ACTUAL

**Status Verified Date:** 2022-12

#### Study First Post Date
**Date:** 2022-06-08
**Type:** ACTUAL
**Study First Submit Date:** 2022-06-03
**Study First Submit QC Date:** 2022-06-03
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Richard M. Schulze Family Foundation

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** AbiliTech Medical Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** True

### Description Module

**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 Module

**Conditions:**

- Muscular Dystrophies

- Spinal Muscular Atrophy

- Duchenne Muscular Dystrophy

- Limb Girdle Muscular Dystrophy

- FSHD

- Cerebral Palsy

- Becker Muscular Dystrophy

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 35

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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 Names:**

- Device: Abilitech Assist

**Label:** Abilitech Assist

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Abilitech Assist

**Description:** 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.

**Name:** Abilitech Assist

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Canadian Occupational Performance Measure (COPM)

**Time Frame:** Change from Baseline before device intervention (30 days), and after device intervention (60 days)

**Description:** 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.

**Measure:** Roll Evaluation of Activities of Life (REAL) assessment

**Time Frame:** Change from Baseline before device intervention (30 days), and after device intervention (60 days)

### Eligibility Module

**Eligibility 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

**Minimum Age:** 10 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** info@abilitechmedical.com

**Name:** Chief Executive Officer

**Phone:** 833.225.3123

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Saint Paul

**Contacts:**

***Contact 1:***

- **Email:** research@gillettechildrens.com

- **Name:** Research

- **Role:** CONTACT

**Country:** United States

**Facility:** Gillette Children's

**State:** Minnesota

**Status:** RECRUITING

**Zip:** 55101

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001925

- Term: Brain Damage, Chronic

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000001284

- Term: Atrophy

- ID: D000020763

- Term: Pathological Conditions, Anatomical

- ID: D000020966

- Term: Muscular Disorders, Atrophic

- ID: D000009135

- Term: Muscular Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000009468

- Term: Neuromuscular Diseases

- ID: D000030342

- Term: Genetic Diseases, Inborn

- ID: D000040181

- Term: Genetic Diseases, X-Linked

- ID: D000020879

- Term: Neuromuscular Manifestations

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000013118

- Term: Spinal Cord Diseases

- ID: D000016472

- Term: Motor Neuron Disease

- ID: D000019636

- Term: Neurodegenerative Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5796

- Name: Cerebral Palsy

- Relevance: HIGH

- As Found: Cerebral Palsy

- ID: M12093

- Name: Muscular Dystrophies

- Relevance: HIGH

- As Found: Muscular Dystrophy

- ID: M12090

- Name: Muscular Atrophy

- Relevance: HIGH

- As Found: Muscular Atrophy

- ID: M12091

- Name: Muscular Atrophy, Spinal

- Relevance: HIGH

- As Found: Spinal Muscular Atrophy

- ID: M4589

- Name: Atrophy

- Relevance: LOW

- As Found: Unknown

- ID: M22185

- Name: Muscular Dystrophy, Duchenne

- Relevance: HIGH

- As Found: Becker Muscular Dystrophy

- ID: M13157

- Name: Paralysis

- Relevance: LOW

- As Found: Unknown

- ID: M26038

- Name: Muscular Dystrophies, Limb-Girdle

- Relevance: HIGH

- As Found: Limb Girdle Muscular Dystrophy

- ID: M5207

- Name: Brain Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M5202

- Name: Brain Damage, Chronic

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

- ID: M12092

- Name: Muscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22697

- Name: Muscular Disorders, Atrophic

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12411

- Name: Neuromuscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M23686

- Name: Genetic Diseases, Inborn

- Relevance: LOW

- As Found: Unknown

- ID: M24877

- Name: Genetic Diseases, X-Linked

- Relevance: LOW

- As Found: Unknown

- ID: M22619

- Name: Neuromuscular Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M15915

- Name: Spinal Cord Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M18879

- Name: Motor Neuron Disease

- Relevance: LOW

- As Found: Unknown

- ID: M4024

- Name: Amyotrophic Lateral Sclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M21558

- Name: Neurodegenerative Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T3963

- Name: Muscular Dystrophy

- Relevance: HIGH

- As Found: Muscular Dystrophy

- ID: T5342

- Name: Spinal Muscular Atrophy

- Relevance: HIGH

- As Found: Spinal Muscular Atrophy

- ID: T698

- Name: Becker Muscular Dystrophy

- Relevance: HIGH

- As Found: Becker Muscular Dystrophy

- ID: T1945

- Name: Duchenne Muscular Dystrophy

- Relevance: HIGH

- As Found: Duchenne Muscular Dystrophy

- ID: T3425

- Name: Limb-girdle Muscular Dystrophy

- Relevance: HIGH

- As Found: Limb Girdle Muscular Dystrophy

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

- ID: T349

- Name: Amyotrophic Lateral Sclerosis

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009136

- Term: Muscular Dystrophies

- ID: D000020388

- Term: Muscular Dystrophy, Duchenne

- ID: D000049288

- Term: Muscular Dystrophies, Limb-Girdle

- ID: D000002547

- Term: Cerebral Palsy

- ID: D000009133

- Term: Muscular Atrophy

- ID: D000009134

- Term: Muscular Atrophy, Spinal

### Misc Info Module

- Version Holder: 2024-05-24
