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Schulze Muscular Dystrophy Ability Clinical Study

Primary Purpose

Muscular Dystrophies, Spinal Muscular Atrophy, Duchenne Muscular Dystrophy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Abilitech Assist
Sponsored by
AbiliTech Medical Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscular Dystrophies

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gillette Children'sRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Abilitech Assist

Arm 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.

Outcomes

Primary Outcome Measures

Canadian Occupational Performance Measure (COPM)
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
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.

Secondary Outcome Measures

Full Information

First Posted
June 3, 2022
Last Updated
December 1, 2022
Sponsor
AbiliTech Medical Inc.
Collaborators
Richard M. Schulze Family Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05409079
Brief Title
Schulze Muscular Dystrophy Ability Clinical Study
Official Title
Schulze Muscular Dystrophy Ability Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 26, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbiliTech Medical Inc.
Collaborators
Richard M. Schulze Family Foundation

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscular Dystrophies, Spinal Muscular Atrophy, Duchenne Muscular Dystrophy, Limb Girdle Muscular Dystrophy, FSHD, Cerebral Palsy, Becker Muscular Dystrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Abilitech Assist
Arm Type
Experimental
Arm 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 Type
Device
Intervention Name(s)
Abilitech Assist
Intervention 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.
Primary Outcome Measure Information:
Title
Canadian Occupational Performance Measure (COPM)
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.
Time Frame
Change from Baseline before device intervention (30 days), and after device intervention (60 days)
Title
Roll Evaluation of Activities of Life (REAL) assessment
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.
Time Frame
Change from Baseline before device intervention (30 days), and after device intervention (60 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chief Executive Officer
Phone
833.225.3123
Email
info@abilitechmedical.com
Facility Information:
Facility Name
Gillette Children's
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research
Email
research@gillettechildrens.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Schulze Muscular Dystrophy Ability Clinical Study

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