New 3D Printed Wrist Orthosis

TOPMED20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carpal Tunnel Syndrome Ulnar Nerve Injury Rhizarthrosis Tendinopathy, Thumb

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Time frame: Baseline and day 14

Secondary Outcomes

Difficulty in donning the orthosis

Yes/No question about having difficulty putting on the orthosis. No unit.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline

Functional disability evaluation of the upper member

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Day 14 of intervention

New 3D Printed Wrist Orthosis

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts