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

NCT ID: NCT04199975

Last Updated: 2019-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-04

Study Completion Date

2020-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Upper Limb Deformities, Congenital

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Orthoses

Only one single arm in this study

Group Type OTHER

Orthoses

Intervention Type DEVICE

Power-Driven or Mechanical Orthoses

Interventions

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Orthoses

Power-Driven or Mechanical Orthoses

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Michael Chu Kay MAK

Associate Consultant and Clinical Assistant Professor (Honorary)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chu Kay Michael Mak, FRCSEd(Orth)

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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Prince of Wales Hospital

Shatin, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Chu Kay Michael Mak, FRCSEd(Orth)

Role: CONTACT

Phone: (852) 3505 2742

Email: [email protected]

Wai Ping Fiona Yu, MPH

Role: CONTACT

Email: [email protected]

Facility Contacts

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Chu Kay Michael MAK, FRCSEd(Orth)

Role: primary

Wai Ping Fiona Yu, MPH

Role: backup

Other Identifiers

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Orthoses_Protocol_v1

Identifier Type: -

Identifier Source: org_study_id