New 3D Printed Wrist Orthosis

Study Overview
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Brief Summary
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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.

Official Title
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Development and Validation of a New Wrist Orthosis by 3D Printing

Conditions
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Carpal Tunnel Syndrome, Ulnar Nerve Injury, Rhizarthrosis, Tendinopathy, Thumb, Tenosynovitis de Quervain, Hand Disease

Intervention / Treatment
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* Device: Wrist and Thumb orthosis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thumb then wrist orthosis<br> | Device: Wrist and Thumb orthosis<br>* Custom 3D printed thumb and wrist orthosis<br>|
| Experimental: Wrist then thumb orthosis<br> | Device: Wrist and Thumb orthosis<br>* Custom 3D printed thumb and wrist orthosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Baseline and day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difficulty in donning the orthosis | Yes/No question about having difficulty putting on the orthosis. No unit. | Each day during 2 weeks of intervention | 
| Comfort | Comfort measure via 1-5 rating, possible scores range from1 (worst possible comfort) to 5 (best possible comfort). No unit. | Each day during 2 weeks of intervention | 
| 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. | Baseline | 
| 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. | Baseline | 
| 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. | Day 14 of intervention | 
| 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. | Baseline | 
| 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. | Day 14 of intervention | 
| 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. | Baseline | 
| 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. | Day 14 of intervention | 
| 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. | Day 14 of intervention | 
| 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. | Day 14 of intervention | 
| 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. | Baseline | 
| 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. | Baseline | 
| 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. | Day 14 of intervention |