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Orthosis

3D Printed Wrist Orthosis for Carpal Tunnel Syndrome

N/A
Recruiting
Research Sponsored by TOPMED
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 14 of intervention
Awards & highlights

Study Summary

This trial will help develop a new 3D printed orthosis to aid with healing and rehab of wrist/hand injuries, like carpal tunnel & droopy hand, for under $150.

Who is the study for?
This trial is for adults aged 18-70 with conditions like Carpal Tunnel Syndrome, De Quervain's Tenosynovitis, Drop hand, Ulnar nerve damage, Rhizarthrosis or Tendinopathy of the thumb. Participants must be able to express comfort and discomfort clearly. It excludes those with neuromuscular issues, spasticity, paralysis or insensitivity in the upper limbs.Check my eligibility
What is being tested?
The study is testing a new type of wrist and thumb orthosis made using 3D printing technology. The goal is to create an affordable ($150), attachment-free brace that supports healing and rehabilitation for various hand and wrist injuries.See study design
What are the potential side effects?
Potential side effects may include discomfort while wearing the orthosis, skin irritation at contact points or reduced mobility due to improper fit. However, specific side effects will depend on individual experiences.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in pain during treatment from baseline at day 14
Secondary outcome measures
Comfort
Difficulty in donning the orthosis
Functional disability evaluation of the upper member
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Wrist then thumb orthosisExperimental Treatment1 Intervention
Group II: Thumb then wrist orthosisExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

MedicusUNKNOWN
TOPMEDLead Sponsor
7 Previous Clinical Trials
508 Total Patients Enrolled
Natural Sciences and Engineering Research Council, CanadaOTHER
58 Previous Clinical Trials
3,081 Total Patients Enrolled

Media Library

Wrist and Thumb Orthosis (Orthosis) Clinical Trial Eligibility Overview. Trial Name: NCT05597930 — N/A
Carpal Tunnel Syndrome Research Study Groups: Wrist then thumb orthosis, Thumb then wrist orthosis
Carpal Tunnel Syndrome Clinical Trial 2023: Wrist and Thumb Orthosis Highlights & Side Effects. Trial Name: NCT05597930 — N/A
Wrist and Thumb Orthosis (Orthosis) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05597930 — N/A
~6 spots leftby Jun 2025
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