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

Upper Limb Deformities, Congenital Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04199975
• Other study ID #: Orthoses_Protocol_v1
• Status: Recruiting
• Phase: N/A
• Start date: October 4, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: December 2019
• Source: Chinese University of Hong Kong
• Contact: Chu Kay Michael Mak, FRCSEd(Orth)
• Phone: (852) 3505 2742
• Email: mmak[@]ort.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Upper Extremity Deformities, Congenital
• Upper Limb Deformities, Congenital

Intervention

Device:
• Orthoses
Power-Driven or Mechanical Orthoses

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

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