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

N/AUnknownNCT04199975

Chinese University of Hong Kong10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Upper Limb Deformities, Congenital

Interventions

OrthosesDEVICE

Power-Driven or Mechanical Orthoses

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Prince of Wales Hospital

Shatin, Hong Kong

RECRUITING

Outcomes

Primary Outcomes

Visual Analogue Scale (VAS) Pain Score

VAS pain score will be measured

Time frame: Baseline

Visual Analogue Scale (VAS) Pain Score

VAS pain score will be measured

Time frame: 1-week after

Short-Form Survey (SF-36)

Generic health status instrument to assess quality of life

Time frame: Baseline

Short-Form Survey (SF-36)

Generic health status instrument to assess quality of life

Time frame: 1-week after

Active and passive range of motion (ROM)

ROM will be measured to determine the joint stiffness

Time frame: Baseline

Active and passive range of motion (ROM)

ROM will be measured to determine the joint stiffness

Time frame: 1-week after

Disability of Arm, Shoulder and Hand (DASH) questionnaire

Specially designed tool to assess upper extremity disability and symptoms

Time frame: Baseline

Disability of Arm, Shoulder and Hand (DASH) questionnaire

Specially designed tool to assess upper extremity disability and symptoms

Time frame: 1-week after

Patients' Satisfaction Score

To grade the subjects' satisfaction regarding to their conditions (0=totally not satisfied; 10=fully satisfied)

Central Contacts

Chu Kay Michael Mak, FRCSEd(Orth)

CONTACT

(852) 3505 2742 mmak@ort.cuhk.edu.hk

Wai Ping Fiona Yu, MPH

CONTACT

fionayuwp@cuhk.edu.hk

Data from ClinicalTrials.gov

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