Upper Limb Deformities, CongenitalNCT04199975
Customized Self-Controlled Power-Driven or Mechanical Orthoses for the Upper Limb - A Pilot Study
A study testing Orthoses in people with Upper Limb Deformities, Congenital, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Upper Limb Deformities, Congenital
- What is being tested?
- Orthoses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteHong Kong
- Study dates
- 4 Oct 2019to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Wai Ping Fiona Yu, MPH contact
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Shatin
Chu Kay Michael MAK, FRCSEd(Orth), (852) 3505 2742, mmak@ort.cuhk.edu.hk
Wai Ping Fiona Yu, MPH, fionayuwp@cuhk.edu.hk
About this study
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.
- Conditions
- Upper Limb Deformities, Congenital
- Being tested
- Orthoses
- Medical subject headings
- Upper Extremity Deformities, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrthosesDevice
Power-Driven or Mechanical Orthoses
| Study group | Role | What they receive |
|---|---|---|
| Orthoses | Other | Only one single arm in this study Receives: Device: Orthoses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS) Pain Score
VAS pain score will be measured
Measured: Baseline
Visual Analogue Scale (VAS) Pain Score
VAS pain score will be measured
Measured: 1-week after
Short-Form Survey (SF-36)
Generic health status instrument to assess quality of life
Measured: Baseline
Short-Form Survey (SF-36)
Generic health status instrument to assess quality of life
Measured: 1-week after
Active and passive range of motion (ROM)
ROM will be measured to determine the joint stiffness
Measured: Baseline
Active and passive range of motion (ROM)
ROM will be measured to determine the joint stiffness
Measured: 1-week after
Disability of Arm, Shoulder and Hand (DASH) questionnaire
Specially designed tool to assess upper extremity disability and symptoms
Measured: Baseline
Disability of Arm, Shoulder and Hand (DASH) questionnaire
Specially designed tool to assess upper extremity disability and symptoms
Measured: 1-week after
Patients' Satisfaction Score
To grade the subjects' satisfaction regarding to their conditions (0=totally not satisfied; 10=fully satisfied)
Measured: Baseline
Patients' Satisfaction Score
To grade the subjects' satisfaction regarding to their conditions (0=totally not satisfied; 10=fully satisfied)
Measured: 1-week after
Grip Strength
Will be measured in kg
Measured: Baseline
Grip Strength
Will be measured in kg
Measured: 1-week after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start4 Oct 2019
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Limb Deformities, CongenitalStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Chu Kay MAK, Chinese University of Hong Kong
- Investigators
- Chu Kay Michael Mak, FRCSEd(Orth), Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199975
- Sponsor's protocol ID
- Orthoses_Protocol_v1
- Status last verified
- Dec 2019
- First submitted
- 4 Dec 2019
- Last updated
- 16 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Customized Self-Controlled Power-Driven or Mechanical Orthoses for the Upper Limb - A Pilot Study
- ClinicalTrials.gov ID
- NCT04199975
- Acronym / sponsor ID
- Orthoses_Protocol_v1
- Conditions
- Upper Limb Deformities, Congenital
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 4 Oct 2019 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 16 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orthoses | Other | Device: OrthosesOnly one single arm in this study |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OrthosesPower-Driven or Mechanical Orthoses | Device | Orthoses |
Primary outcome
Visual Analogue Scale (VAS) Pain Score
Time frame: Baseline
VAS pain score will be measured
Visual Analogue Scale (VAS) Pain Score
Time frame: 1-week after
VAS pain score will be measured
Short-Form Survey (SF-36)
Time frame: Baseline
Generic health status instrument to assess quality of life
Short-Form Survey (SF-36)
Time frame: 1-week after
Generic health status instrument to assess quality of life
Active and passive range of motion (ROM)
Time frame: Baseline
ROM will be measured to determine the joint stiffness
Active and passive range of motion (ROM)
Time frame: 1-week after
ROM will be measured to determine the joint stiffness
Disability of Arm, Shoulder and Hand (DASH) questionnaire
Time frame: Baseline
Specially designed tool to assess upper extremity disability and symptoms
Disability of Arm, Shoulder and Hand (DASH) questionnaire
Time frame: 1-week after
Specially designed tool to assess upper extremity disability and symptoms
Patients' Satisfaction Score
Time frame: Baseline
To grade the subjects' satisfaction regarding to their conditions (0=totally not satisfied; 10=fully satisfied)
Patients' Satisfaction Score
Time frame: 1-week after
To grade the subjects' satisfaction regarding to their conditions (0=totally not satisfied; 10=fully satisfied)
Grip Strength
Time frame: Baseline
Will be measured in kg
Grip Strength
Time frame: 1-week after
Will be measured in kg
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wai Ping Fiona Yu, MPH contact
Chu Kay Michael Mak, FRCSEd(Orth) principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orthoses in people with Upper Limb Deformities, Congenital, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chu Kay Michael Mak, FRCSEd(Orth) ((852) 3505 2742, mmak@ort.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) Pain Score (time frame: Baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2019.