Ablelite Pediatric Device Clinical Study

Muscular Dystrophies Clinical Trial

Official title:

Ablelite Pediatric Device Clinical Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04308447
• Other study ID #: PR610003-100
• Secondary ID: 2R44HD089789-02
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: January 31, 2021

Study information

• Verified date: March 2020
• Source: AbiliTech Medical Inc.
• Contact: Director of Clinical and Product Management
• Phone: 833.225.3123
• Email: info[@]abilitechmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: January 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscular Dystrophies

Intervention

Device:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
AbiliTech Medical Inc.	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Gillette Children's Specialty Healthcare

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from Baseline before device intervention (30 days), and after device intervention (60 days)
Primary	Roll Evaluation of Activities of Life (REAL) assessment	The REAL is an instrument to help professionals assess a child's ability to care for themselves at home, at school and in the community.	Change from Baseline before device intervention (30 days), and after device intervention (60 days)