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

Study Overview
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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.

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

Conditions
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Upper Limb Deformities, Congenital

Intervention / Treatment
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* Device: Orthoses


Participation Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Orthoses<br>Only one single arm in this study | Device: Orthoses<br>* Power-Driven or Mechanical Orthoses<br>|

What is the study measuring?
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Primary Outcome Measures

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