Ablelite Pediatric Device Clinical Study

NCT ID: NCT04308447

Last Updated: 2020-03-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2021-01-31

Brief Summary

The primary objective of the AbleLite early feasibility study is to evaluate the function of the upper limbs of participants diagnosed with neuromuscular disorders as children, with and without use of the Abilitech AbleLite 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.

Conditions

Muscular Dystrophies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AbleLite

The AbleLite device is a passively powered orthotic device designed to support and assist the arms of patients with neuromuscular weakness for activities of daily living.

Group Type: EXPERIMENTAL

AbleLite

Intervention Type: DEVICE

The AbleLite 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

AbleLite

The AbleLite 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

Eligibility Criteria

Inclusion Criteria

1. Subjects between 9 and 18 years of age, with pediatric onset of neuromuscular conditions that cause quadriparesis

2. MMT score of 1-3 in the elbow, wrist and hands, and an MMT score of 2- to 3 in the shoulder

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 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

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 Eligible Age: 9 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gillette Children's Specialty Healthcare

OTHER

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

AbiliTech Medical Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Director of Clinical and Product Management

Role: CONTACT

info@abilitechmedical.com

833.225.3123

Other Identifiers

2R44HD089789-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PR610003-100

Identifier Type: -

Identifier Source: org_study_id