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Schulze Muscular Dystrophy Ability Clinical Study

A

Abilitech Medical

Status

Enrolling

Conditions

Cerebral Palsy
FSHD
Muscular Dystrophies
Becker Muscular Dystrophy
Limb Girdle Muscular Dystrophy
Duchenne Muscular Dystrophy
Spinal Muscular Atrophy

Treatments

Device: Abilitech Assist

Study type

Interventional

Funder types

Industry
Other

Identifiers

NCT05409079
Schulze

Details and patient eligibility

About

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.

Enrollment

35 estimated patients

Sex

All

Ages

10+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

35 participants in 1 patient group

Abilitech Assist
Experimental group
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.
Treatment:
Device: Abilitech Assist

Trial contacts and locations

1

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Central trial contact

Chief Executive Officer

Data sourced from clinicaltrials.gov

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