Customized Self-Controlled Power-Driven or Mechanical Orthoses for the Upper Limb - A Pilot Study

The Chinese University of Hong Kong

Status: Unknown

Conditions: Upper Limb Deformities, Congenital

Treatments: Device: Orthoses

Study type: Interventional

Funder types: Other

Identifiers

NCT04199975

Orthoses_Protocol_v1

Details and patient eligibility

About

Patients with congenital or acquired upper limb structural abnormalities and peripheral nerve or brachial plexus palsies have significant loss of function. The use of orthoses may improve function particularly in performing specific tasks for which the orthoses are designed, depending on the patients' deficiencies and needs. The performance of orthoses may be enhanced by being light-weight, motor-driven, and ergonomic.

This pilot, prospective study is designed to test the feasibility and effectiveness of the specially designed orthoses.

Enrollment: 10 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with any congenital or acquired upper limb structural abnormalities
• Patients' condition is not suitable for surgical intervention or patients are not keen for surgical treatment

Exclusion criteria

• Patients have no available muscle signal input
• Patients fitted with a pacemaker or an implantable cardioverter defibrillator (ICD) or other implantable electrical devices
• Patients with contact dermatitis

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Orthoses

Other group

Description:

Only one single arm in this study

Treatment:

Device: Orthoses