User-centred Assistive System for Arm Functions in Neuromuscular Subjects (USEFUL)

Politecnico di Milano

Status: Completed

Conditions: Muscular Dystrophy, Becker; Muscular Dystrophies; Muscular Dystrophy, Duchenne; Muscular Dystrophy, Limb-Girdle Type 2

Treatments: Device: Assistive device (Armon Ayura) test; Device: Assistive device (Jaeco Wrex) test

Study type: Interventional

Funder types: Other

Identifiers

NCT03127241

GUP 15021

Details and patient eligibility

About

Restore a lost function is a special experience for people affected by neuromuscular evolutive diseases. "From the patient's point of view improvement is measured by regaining lost abilities,-by being able to do something -anything-today I couldn't do yesterday ". Upper limb pain, stiffness and activity limitations have a crucial role in reducing patients' autonomy and worsening quality of life.

Real users' needs have been identified thought several workshops, and even if the commercial products might assure a benefit to some users and meet most of their requirements, so far a validation of the use of such devices by people with neuromuscular disease is missing.

We aim at field-testing the improvement in arm functions provided by the use of some commercial devices and assessing their impact to users' quality of life and independence. This step is essential to assure a widespread accessibility to these devices for most of the potential users, possibly providing health providers with direction and guidance towards Health Technology Assessment.

Clinical Trial design - The study proposes on-field validation of JAECO WREX, passive antigravity exoskeleton; and Armon Ayura, motorized arm exoskeleton for gravity compensation in a randomized controlled trial with crossover design. The clinical study will is multi-centric, involving both MEDEA and VALDUCE, and received the Ethical Committee approval.

Enrollment: 38 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• signed informed consent (we will expose the family the aims of our study and carefully describe the need of compliance with them)
• diagnosis of muscular dystrophy (genetic, histological and biochemical if necessary),specifically with Duchenne, Becker and Limb Girdle type 2 muscular dystrophy. No muscle biopsy will be performed, except in case there is a diagnostic need.
• being wheelchair bound
• having a scoring at the MRC scale for upper limb at the deltoid, biceps, triceps brachii muscles ranging from 2 to 4.

Exclusion criteria

• presence of additional diseases (for example: family history of mental retardation, epilepsy, cerebral palsy)
• behavioral and psychiatric disturbances (emotional problems, depression)
• absence of compliance to the study of the family and the caregivers

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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38 participants in 2 patient groups

Armon Ayura

Active Comparator group

Description:

Upper limb assistive device with active solutions for gravity compensation. Intervention: The upper limb exoskeleton is worn by the patient on the preferred arm, and it is used during daily life activities to support arm movements, particularly getting rid of gravity arm weight.

Treatment:

Device: Assistive device (Armon Ayura) test

Jaeco Wrex

Active Comparator group

Description:

Upper limb assistive device with passive solutions for gravity compensation. Intervention: The upper limb exoskeleton is worn by the patient on the preferred arm, and it is used during daily life activities to support arm movements, particularly getting rid of gravity arm weight.

Treatment:

Device: Assistive device (Jaeco Wrex) test