Carpal Tunnel Syndrome, Hand Disease, Rhizarthrosis, Tendinopathy, Thumb, Tenosynovitis de Quervain, Ulnar Nerve Injury
Conditions
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.
Interventions
DEVICEWrist and Thumb orthosis
Custom 3D printed thumb and wrist orthosis
Sponsors
Medicus
Natural Sciences and Engineering Research Council, Canada
TOPMED
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain during treatment from baseline at day 14 | Baseline and 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
| Measure | Time frame | Description |
|---|---|---|
| Comfort | Each day during 2 weeks of intervention | 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 | 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 | Baseline | 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 | Baseline | 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 | Baseline | 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. |
| Difficulty in donning the orthosis | Each day during 2 weeks of intervention | Yes/No question about having difficulty putting on the orthosis. No unit. |
| aesthetic satisfaction rating at day 14 of intervention | 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 | 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 | 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 | 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. |
| Weight satisfaction rating at day 14 of intervention | 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. |
Countries
Canada
Contacts
Primary ContactEdith Martin, PhD
Outcome results
None listed