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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04199975

Enrollment

Registered

2019-12-16

Start date

2019-10-04

Completion date

2020-09-30

Last updated

2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper Limb Deformities, Congenital

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.

Interventions

DEVICEOrthoses

Power-Driven or Mechanical Orthoses

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Hong Kong

Contacts

Primary ContactChu Kay Michael Mak, FRCSEd(Orth)

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

Backup ContactWai Ping Fiona Yu, MPH

fionayuwp@cuhk.edu.hk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026