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

Primary Purpose

Upper Limb Deformities, Congenital

Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Orthoses
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Upper Limb Deformities, Congenital

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Prince of Wales HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Orthoses

Arm Description

Only one single arm in this study

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 4, 2019
Last Updated
December 13, 2019
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04199975
Brief Title
Customized Self-Controlled Power-Driven or Mechanical Orthoses for the Upper Limb - A Pilot Study
Official Title
Customized Self-Controlled Power-Driven or Mechanical Orthoses for the Upper Limb - A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 4, 2019 (Actual)
Primary Completion Date
September 30, 2020 (Anticipated)
Study Completion Date
September 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Limb Deformities, Congenital

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chu Kay Michael Mak, FRCSEd(Orth)
Phone
(852) 3505 2742
Email
mmak@ort.cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Wai Ping Fiona Yu, MPH
Email
fionayuwp@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chu Kay Michael Mak, FRCSEd(Orth)
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Shatin
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chu Kay Michael MAK, FRCSEd(Orth)
Phone
(852) 3505 2742
Email
mmak@ort.cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Wai Ping Fiona Yu, MPH
Email
fionayuwp@cuhk.edu.hk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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