NCT04199975

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 4, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 16, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

December 16, 2019

Status Verified

December 1, 2019

Enrollment Period

12 months

First QC Date

December 4, 2019

Last Update Submit

December 13, 2019

Conditions

Upper Limb Deformities, Congenital

Outcome Measures

Primary Outcomes (12)

  • Visual Analogue Scale (VAS) Pain Score

    VAS pain score will be measured

    Baseline

  • Visual Analogue Scale (VAS) Pain Score

    VAS pain score will be measured

    1-week after

  • Short-Form Survey (SF-36)

    Generic health status instrument to assess quality of life

    Baseline

  • Short-Form Survey (SF-36)

    Generic health status instrument to assess quality of life

    1-week after

  • Active and passive range of motion (ROM)

    ROM will be measured to determine the joint stiffness

    Baseline

  • Active and passive range of motion (ROM)

    ROM will be measured to determine the joint stiffness

    1-week after

  • Disability of Arm, Shoulder and Hand (DASH) questionnaire

    Specially designed tool to assess upper extremity disability and symptoms

    Baseline

  • Disability of Arm, Shoulder and Hand (DASH) questionnaire

    Specially designed tool to assess upper extremity disability and symptoms

    1-week after

  • Patients' Satisfaction Score

    To grade the subjects' satisfaction regarding to their conditions (0=totally not satisfied; 10=fully satisfied)

    Baseline

  • Patients' Satisfaction Score

    To grade the subjects' satisfaction regarding to their conditions (0=totally not satisfied; 10=fully satisfied)

    1-week after

  • Grip Strength

    Will be measured in kg

    Baseline

  • Grip Strength

    Will be measured in kg

    1-week after

Study Arms (1)

Orthoses

OTHER

Only one single arm in this study

Device: Orthoses

Interventions

OrthosesDEVICE

Power-Driven or Mechanical Orthoses

Orthoses

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

RECRUITING

MeSH Terms

Conditions

Upper Extremity Deformities, Congenital

Interventions

Orthotic Devices

Condition Hierarchy (Ancestors)

Limb Deformities, CongenitalMusculoskeletal AbnormalitiesMusculoskeletal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Orthopedic EquipmentSurgical EquipmentEquipment and Supplies

Study Officials

  • Chu Kay Michael Mak, FRCSEd(Orth)

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chu Kay Michael Mak, FRCSEd(Orth)

CONTACT

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

Wai Ping Fiona Yu, MPH

CONTACT

fionayuwp@cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Consultant and Clinical Assistant Professor (Honorary)

Study Record Dates

First Submitted

December 4, 2019

First Posted

December 16, 2019

Study Start

October 4, 2019

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

December 16, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)