New 3D Printed Wrist Orthosis
Primary Purpose
Carpal Tunnel Syndrome, Ulnar Nerve Injury, Rhizarthrosis
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Wrist and Thumb orthosis
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome
Eligibility Criteria
Inclusion Criteria:
- Be between 18 and 70 years old
- Ability to accurately communicate comfort and discomfort,
- Carpal tunnel syndrome, or
- de Quervain's tenosynovitis, or
- Drop hand, or
- Ulnar nerve damage
- Rhizarthrosis, or
- Tendinopathy of the thumb
- And/or ulnar gale
Exclusion Criteria:
- - Spasticity in the upper limbs
- Paralysis, Insensitivity of the upper limbs
- Neuromuscular pathology affecting the upper limbs
Sites / Locations
- TOPMEDRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Thumb then wrist orthosis
Wrist then thumb orthosis
Arm Description
Outcomes
Primary Outcome Measures
Change in pain during treatment from baseline at day 14
Pain measure via 1-5 rating, possible scores range from1 (no pain) to 5 (worst possible pain). Change = (Day 14 score - baseline score)
Secondary Outcome Measures
Difficulty in donning the orthosis
Yes/No question about having difficulty putting on the orthosis. No unit.
Comfort
Comfort measure via 1-5 rating, possible scores range from1 (worst possible comfort) to 5 (best possible comfort). No unit.
Weight satisfaction rating at baseline
Weight satisfaction measure via 1-5 rating, possible scores range from1 (worst possible satisfaction) to 5 (best possible satisfaction). No unit.
Satisfaction on ease of donning
Satisfaction measure via 1-5 rating on ease of donning, possible scores range from 1 (worst possible satisfaction) to 5 (best possible satisfaction). No unit.
Satisfaction on ease of donning
Satisfaction measure via 1-5 rating on ease of donning, possible scores range from 1 (worst possible satisfaction) to 5 (best possible satisfaction). No unit.
Satisfaction on ease of doffing
Satisfaction measure via 1-5 rating on ease of doffing, possible scores range from 1 (worst possible satisfaction) to 5 (best possible satisfaction). No unit.
Satisfaction on ease of doffing
Satisfaction measure via 1-5 rating on ease of doffing, possible scores range from 1 (worst possible satisfaction) to 5 (best possible satisfaction). No unit.
Functional disability evaluation of the upper member
Evaluation of disability of arm, shoulder and hand in activities of daily living via Quick Disability of arm, shoulder and hand (Quick DASH) (validated 11 elements 5-point rating). Possible scores range from 1 (No difficulty) to 5 (Incapacity to complete task). No unit.
Functional disability evaluation of the upper member
Evaluation of disability of arm, shoulder and hand in activities of daily living via Quick Disability of arm, shoulder and hand (Quick DASH) (validated 11 elements 5-point rating). Possible scores range from 1 (No difficulty) to 5 (Incapacity to complete task). No unit.
Weight satisfaction rating at day 14 of intervention
Weight satisfaction measure via 1-5 rating, possible scores range from1 (worst possible satisfaction) to 5 (best possible satisfaction). No unit.
aesthetic satisfaction rating at day 14 of intervention
Aesthetic satisfaction measure via 1-5 rating, possible scores range from1 (worst possible satisfaction) to 5 (best possible satisfaction). No unit.
aesthetic satisfaction rating at baseline
Aesthetic satisfaction measure via 1-5 rating, possible scores range from1 (worst possible satisfaction) to 5 (best possible satisfaction). No unit.
material quality satisfaction rating at baseline
Material quality satisfaction measure via 1-5 rating, possible scores range from1 (worst possible satisfaction) to 5 (best possible satisfaction). No unit.
material quality satisfaction rating at day 14 of intervention
Material quality satisfaction measure via 1-5 rating, possible scores range from1 (worst possible satisfaction) to 5 (best possible satisfaction). No unit.
Full Information
NCT ID
NCT05597930
First Posted
October 20, 2022
Last Updated
July 10, 2023
Sponsor
TOPMED
Collaborators
Medicus, Natural Sciences and Engineering Research Council, Canada
1. Study Identification
Unique Protocol Identification Number
NCT05597930
Brief Title
New 3D Printed Wrist Orthosis
Official Title
Development and Validation of a New Wrist Orthosis by 3D Printing
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2, 2022 (Actual)
Primary Completion Date
May 24, 2024 (Anticipated)
Study Completion Date
May 24, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TOPMED
Collaborators
Medicus, Natural Sciences and Engineering Research Council, Canada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In order to offer a new product improving the healing and/or rehabilitation of injuries or injuries to the wrist and hand, Médicus is seeking to develop a new orthosis for the wrist and hand by 3D printing. This project will focus on the development of an orthosis related to carpal tunnel syndrome as well as droopy hand. Among the issues to be addressed in this development proposal, the investigators find: 1) Identification of the best methodology for taking digital impressions; design of an orthosis with the following characteristics: (i) no external attachment system, (ii) spiral design with a thumb ring, (iii) manufacturing by 3D printing and (iv) a cost of less than $150 ;3) Performing technical and clinical trials.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome, Ulnar Nerve Injury, Rhizarthrosis, Tendinopathy, Thumb, Tenosynovitis de Quervain, Hand Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Thumb then wrist orthosis
Arm Type
Experimental
Arm Title
Wrist then thumb orthosis
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Wrist and Thumb orthosis
Intervention Description
Custom 3D printed thumb and wrist orthosis
Primary Outcome Measure Information:
Title
Change in pain during treatment from baseline at day 14
Description
Pain measure via 1-5 rating, possible scores range from1 (no pain) to 5 (worst possible pain). Change = (Day 14 score - baseline score)
Time Frame
Baseline and day 14
Secondary Outcome Measure Information:
Title
Difficulty in donning the orthosis
Description
Yes/No question about having difficulty putting on the orthosis. No unit.
Time Frame
Each day during 2 weeks of intervention
Title
Comfort
Description
Comfort measure via 1-5 rating, possible scores range from1 (worst possible comfort) to 5 (best possible comfort). No unit.
Time Frame
Each day during 2 weeks of intervention
Title
Weight satisfaction rating at baseline
Description
Weight satisfaction measure via 1-5 rating, possible scores range from1 (worst possible satisfaction) to 5 (best possible satisfaction). No unit.
Time Frame
Baseline
Title
Satisfaction on ease of donning
Description
Satisfaction measure via 1-5 rating on ease of donning, possible scores range from 1 (worst possible satisfaction) to 5 (best possible satisfaction). No unit.
Time Frame
Baseline
Title
Satisfaction on ease of donning
Description
Satisfaction measure via 1-5 rating on ease of donning, possible scores range from 1 (worst possible satisfaction) to 5 (best possible satisfaction). No unit.
Time Frame
Day 14 of intervention
Title
Satisfaction on ease of doffing
Description
Satisfaction measure via 1-5 rating on ease of doffing, possible scores range from 1 (worst possible satisfaction) to 5 (best possible satisfaction). No unit.
Time Frame
Baseline
Title
Satisfaction on ease of doffing
Description
Satisfaction measure via 1-5 rating on ease of doffing, possible scores range from 1 (worst possible satisfaction) to 5 (best possible satisfaction). No unit.
Time Frame
Day 14 of intervention
Title
Functional disability evaluation of the upper member
Description
Evaluation of disability of arm, shoulder and hand in activities of daily living via Quick Disability of arm, shoulder and hand (Quick DASH) (validated 11 elements 5-point rating). Possible scores range from 1 (No difficulty) to 5 (Incapacity to complete task). No unit.
Time Frame
Baseline
Title
Functional disability evaluation of the upper member
Description
Evaluation of disability of arm, shoulder and hand in activities of daily living via Quick Disability of arm, shoulder and hand (Quick DASH) (validated 11 elements 5-point rating). Possible scores range from 1 (No difficulty) to 5 (Incapacity to complete task). No unit.
Time Frame
Day 14 of intervention
Title
Weight satisfaction rating at day 14 of intervention
Description
Weight satisfaction measure via 1-5 rating, possible scores range from1 (worst possible satisfaction) to 5 (best possible satisfaction). No unit.
Time Frame
Day 14 of intervention
Title
aesthetic satisfaction rating at day 14 of intervention
Description
Aesthetic satisfaction measure via 1-5 rating, possible scores range from1 (worst possible satisfaction) to 5 (best possible satisfaction). No unit.
Time Frame
Day 14 of intervention
Title
aesthetic satisfaction rating at baseline
Description
Aesthetic satisfaction measure via 1-5 rating, possible scores range from1 (worst possible satisfaction) to 5 (best possible satisfaction). No unit.
Time Frame
Baseline
Title
material quality satisfaction rating at baseline
Description
Material quality satisfaction measure via 1-5 rating, possible scores range from1 (worst possible satisfaction) to 5 (best possible satisfaction). No unit.
Time Frame
Baseline
Title
material quality satisfaction rating at day 14 of intervention
Description
Material quality satisfaction measure via 1-5 rating, possible scores range from1 (worst possible satisfaction) to 5 (best possible satisfaction). No unit.
Time Frame
Day 14 of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be between 18 and 70 years old
Ability to accurately communicate comfort and discomfort,
Carpal tunnel syndrome, or
de Quervain's tenosynovitis, or
Drop hand, or
Ulnar nerve damage
Rhizarthrosis, or
Tendinopathy of the thumb
And/or ulnar gale
Exclusion Criteria:
- Spasticity in the upper limbs
Paralysis, Insensitivity of the upper limbs
Neuromuscular pathology affecting the upper limbs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Edith Martin, PhD
Phone
4187801301
Email
emartin@topmed.ca
Facility Information:
Facility Name
TOPMED
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1S1C1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edith Martin, PhD
Phone
4187801301
Email
emartin@topmed.ca
First Name & Middle Initial & Last Name & Degree
Marianne Lancelot
Phone
4187801301
Email
mlancelot@topmed.ca
12. IPD Sharing Statement
Plan to Share IPD
No
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New 3D Printed Wrist Orthosis
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