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

December 13, 2019 updated by: Michael Chu Kay MAK, Chinese University of Hong Kong

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Chu Kay Michael Mak, FRCSEd(Orth), Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2019

Primary Completion (Anticipated)

September 30, 2020

Study Completion (Anticipated)

September 30, 2020

Study Registration Dates

First Submitted

December 4, 2019

First Submitted That Met QC Criteria

December 13, 2019

First Posted (Actual)

December 16, 2019

Study Record Updates

Last Update Posted (Actual)

December 16, 2019

Last Update Submitted That Met QC Criteria

December 13, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Orthoses_Protocol_v1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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