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

Not Applicable

• Conditions: Upper Limb Deformities, Congenital
• Interventions: Device: Orthoses

• Registration Number: NCT04199975
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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

Not available

Study Timeline

• Study Start: 2019-10-04
• Status Verified: 2019-12
• Study First Submitted: 2019-12-04
• Study First Submitted QC: 2019-12-13
• Last Update Submitted: 2019-12-13
• Study First Posted: 2019-12-16
• Last Update Posted: 2019-12-16
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Orthoses	Orthoses	Only one single arm in this study

Primary Outcome Measures

Name	Time	Method
Disability of Arm, Shoulder and Hand (DASH) questionnaire	1-week after	Specially designed tool to assess upper extremity disability and symptoms
Grip Strength	1-week after	Will be measured in kg
Patients' Satisfaction Score	1-week after	To grade the subjects' satisfaction regarding to their conditions (0=totally not satisfied; 10=fully satisfied)
Visual Analogue Scale (VAS) Pain Score	1-week after	VAS pain score will be measured
Short-Form Survey (SF-36)	1-week after	Generic health status instrument to assess quality of life
Active and passive range of motion (ROM)	1-week after	ROM will be measured to determine the joint stiffness

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Shatin, Hong Kong