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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04199975
Recruitment Status : Recruiting
First Posted : December 16, 2019
Last Update Posted : December 16, 2019
Sponsor:
Information provided by (Responsible Party):
Michael Chu Kay MAK, Chinese University of Hong Kong

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.


Condition or disease Intervention/treatment Phase
Upper Limb Deformities, Congenital Device: Orthoses Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Customized Self-Controlled Power-Driven or Mechanical Orthoses for the Upper Limb - A Pilot Study
Actual Study Start Date : October 4, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Arm Intervention/treatment
Orthoses
Only one single arm in this study
Device: Orthoses
Power-Driven or Mechanical Orthoses




Primary Outcome Measures :
  1. Visual Analogue Scale (VAS) Pain Score [ Time Frame: Baseline ]
    VAS pain score will be measured

  2. Visual Analogue Scale (VAS) Pain Score [ Time Frame: 1-week after ]
    VAS pain score will be measured

  3. Short-Form Survey (SF-36) [ Time Frame: Baseline ]
    Generic health status instrument to assess quality of life

  4. Short-Form Survey (SF-36) [ Time Frame: 1-week after ]
    Generic health status instrument to assess quality of life

  5. Active and passive range of motion (ROM) [ Time Frame: Baseline ]
    ROM will be measured to determine the joint stiffness

  6. Active and passive range of motion (ROM) [ Time Frame: 1-week after ]
    ROM will be measured to determine the joint stiffness

  7. Disability of Arm, Shoulder and Hand (DASH) questionnaire [ Time Frame: Baseline ]
    Specially designed tool to assess upper extremity disability and symptoms

  8. Disability of Arm, Shoulder and Hand (DASH) questionnaire [ Time Frame: 1-week after ]
    Specially designed tool to assess upper extremity disability and symptoms

  9. Patients' Satisfaction Score [ Time Frame: Baseline ]
    To grade the subjects' satisfaction regarding to their conditions (0=totally not satisfied; 10=fully satisfied)

  10. Patients' Satisfaction Score [ Time Frame: 1-week after ]
    To grade the subjects' satisfaction regarding to their conditions (0=totally not satisfied; 10=fully satisfied)

  11. Grip Strength [ Time Frame: Baseline ]
    Will be measured in kg

  12. Grip Strength [ Time Frame: 1-week after ]
    Will be measured in kg



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04199975


Contacts
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Contact: Chu Kay Michael Mak, FRCSEd(Orth) (852) 3505 2742 mmak@ort.cuhk.edu.hk
Contact: Wai Ping Fiona Yu, MPH fionayuwp@cuhk.edu.hk

Locations
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Hong Kong
Prince of Wales Hospital Recruiting
Shatin, Hong Kong
Contact: Chu Kay Michael MAK, FRCSEd(Orth)    (852) 3505 2742    mmak@ort.cuhk.edu.hk   
Contact: Wai Ping Fiona Yu, MPH       fionayuwp@cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Chu Kay Michael Mak, FRCSEd(Orth) Chinese University of Hong Kong
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Responsible Party: Michael Chu Kay MAK, Associate Consultant and Clinical Assistant Professor (Honorary), Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT04199975    
Other Study ID Numbers: Orthoses_Protocol_v1
First Posted: December 16, 2019    Key Record Dates
Last Update Posted: December 16, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Limb Deformities, Congenital
Upper Extremity Deformities, Congenital
Congenital Abnormalities
Musculoskeletal Abnormalities
Musculoskeletal Diseases