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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05597930
Other study ID # RD-21-0376
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 2, 2022
Est. completion date May 24, 2024

Study information

Verified date July 2023
Source TOPMED
Contact Edith Martin, PhD
Phone 4187801301
Email emartin@topmed.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date May 24, 2024
Est. primary completion date May 24, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Intervention

Device:
Wrist and Thumb orthosis
Custom 3D printed thumb and wrist orthosis

Locations

Country Name City State
Canada TOPMED Québec Quebec

Sponsors (3)

Lead Sponsor Collaborator
TOPMED Medicus, Natural Sciences and Engineering Research Council, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Difficulty in donning the orthosis Yes/No question about having difficulty putting on the orthosis. No unit. Each day during 2 weeks of intervention
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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